Administración de surfactante mediante técnica mínimamente invasiva en neonatos / Administration of Surfactants by Minimally Invasive Technique in Neonates

Introducción: La administración de surfactante pulmonar tradicionalmente se realiza mediante un tubo endotraqueal, pero desde hace años existen técnicas menos invasivas como la administración mediante másscara laríngea, aerosolización y cateterización traqueal. Objetivos: Demostrar la evolución de tres neonatos que recibieron surfactante pulmonar mediante una cateterización traqueal y describir la técnica empleada para su administración. Presentación de casos: Se atendieron tres recién nacidos de muy bajo peso al nacer, que ingresaron en la unidad de cuidados intensivos neonatales del Hospital General Docente Iván Portuondo, San Antonio de los Baños, con síndrome de dificultad respiratoria del prematuro. Todos se trataron con surfactante pulmonar exógeno, Surfacen®, el cual se administró mediante cateterización traqueal empleando un catéter umbilical. Se trata de una técnica mínimamente invasiva que se realizó sin dificultades y siempre en el primer intento. Los tres pacientes mostraron mejoría clínica, gasométrica y radiográfica con esta forma de administración y solo uno de ellos tuvo una complicación durante el proceder, que no constituyó una limitante para su realización. Este método permitió mantener una ventilación no invasiva, y fue innecesaria la intubación endotraqueal en los neonatos. Los profesionales encargados de la ejecución de esta técnica recibieron entrenamiento previo. Conclusiones: La administración mínimamente invasiva de surfactante pulmonar resultó un método eficaz con el que se consiguió la resolución total del cuadro de dificultad respiratoria en los neonatos. El procedimiento empleado permitió una administración rápida y segura del Surfacen®(AU)

Introduction: Pulmonary surfactant administration is traditionally performed by endotracheal tube, but for years there have been less invasive techniques such as administration by laryngeal mask, aerosolization and tracheal catheterization. Objectives: To demonstrate the evolution of three neonates who received pulmonary surfactant via tracheal catheterization and to describe the technique used for its administration. Case presentation: Three very low birth weight newborns were attended and admitted to the neonatal intensive care unit of Iván Portuondo General Teaching Hospital, at San Antonio de los Baños municipality, with preterm respiratory distress syndrome. All were treated with exogenous pulmonary surfactant, Surfacen®, which was administered by tracheal catheterization using an umbilical catheter. This is a minimally invasive technique that was performed without difficulty and always on the first attempt. The three patients showed clinical, gasometric and radiographic improvement with this form of administration and only one of them had a complication during the procedure, which did not constitute a limitation for its performance. This method allowed maintaining non-invasive ventilation, and endotracheal intubation was unnecessary in neonates. The professionals in charge of performing this technique received previous training. Conclusions: Minimally invasive administration of pulmonary surfactant was an effective method that achieved total resolution of respiratory distress in neonates. The procedure used allowed rapid and safe administration of Surfacen®(AU)

Eficácia do uso do surfactante exógeno em recém-nascidos de uma UTI Neonatal / Effectiveness of the use of exogenous surfactant in newborn in a neonatal ICU

Introdução: A Doença da Membrana Hialina (DMH) é provocada pela ausência ou deficiência de surfactante, acomete os recém-nascidos prematuros, e o tratamento é realizado com surfactante exógeno. Objetivo: Avaliar a eficácia da terapia com o uso do surfactante exógeno nos distúrbios respiratórios em recém-nascidos. Métodos: Um estudo transversal, descritivo e quantitativo foi realizado com 31 recém-nascidos admitidos na UTI Neonatal do Hospital Santa Casa de Misericórdia de Patrocínio, MG. Para a coleta dos dados, foi elaborado um roteiro estruturado pelas pesquisadoras. Os dados foram analisados por meio dos testes estatísticos: Kolmogorov-Smirnov, Fisher (p ≤ 0,05) e Wilcoxon (p ≤ 0,05). Resultados: O DMH prevaleceu no sexo feminino (51,6%), a maioria prematuros (83,9%) e com baixo peso ao nascer (51,6%). Daqueles que necessitaram do corticoide antenatal, 38,7% usaram duas doses, sendo o Grau III da DMH o mais evidente (35,5%). Todos os recém-nascidos usaram ao menos uma dose de surfactante (58,1%), devido a DMH (87,1%) e a Síndrome da Aspiração Meconial (12,9%). Conclusão: Conclui-se que o distúrbio respiratório mais encontrado nos prematuros foi a DMH, comprovando a evolução positiva dos neonatos após administração do surfactante exógeno e constatando a eficácia do medicamento como tratamento, utilizando-se apenas uma dose.

Seguridad del tratamiento con surfactante pulmonar en el síndrome de dificultad respiratoria aguda en niños / Safety of pulmonary surfactant therapy in acute respiratory distress syndrome in children

RESUMEN Introducción: Los surfactantes pulmonares junto a otras medidas terapéuticas constituyen un tratamiento de elección en diversas afecciones respiratorias. Objetivo: Demostrar la seguridad del tratamiento con Surfacen® en el síndrome de dificultad respiratoria aguda en niños. Materiales y Métodos: Ensayo clínico fase III multicéntrico, abierto, controlado y aleatorizado con dos grupos de tratamiento. El Grupo A recibió tratamiento convencional de oxigenación y ventilación mecánica combinado con Surfacen® en dosis de 100 mg cada ocho horas durante tres días. El Grupo B recibió tratamiento convencional. Se incluyeron niños entre los 28 días de nacido hasta 18 años de edad, de cualquier sexo, con diagnóstico de síndrome de dificultad respiratoria aguda. Se identificó y cuantificó la aparición de eventos adversos, intensidad, actitud seguida ante su aparición, resultado, relación de causalidad y mortalidad al día 28. Resultados: Se incluyeron 42 niños: 20 en el grupo A y 22 en el grupo B. En el grupo A se reportaron 23 eventos adversos en nueve pacientes y en el grupo B, 97 eventos adversos en 18 pacientes. La hipertensión arterial fue el evento adverso más frecuente. En el grupo A, 73,9% de los eventos adversos se manifestaron con intensidad severa, 86,9 % se mantuvo sin cambios frente al medicamento, 73,9 % tuvo causalidad remota respecto al surfactante. La mortalidad al día 28 fue de 41,5 %; en el grupo A, 20 % y en el grupo B, 62%. Conclusiones: Surfacen® fue bien tolerado y seguro al notificarse un número reducido de eventos adversos relacionados con su administración.

ABSTRACT Introduction: Pulmonary surfactants, together with other therapeutic measures, constitute a treatment of choice for various respiratory conditions. Objective: To demonstrate the safety of the treatment with Surfacen® in acute respiratory distress syndrome in children. Material and Methods: A multicenter, open, controlled, randomized Phase III clinical trial with two treatment groups. Group A received conventional oxygen therapy and mechanical ventilation combined with Surfacen® at a dosage of 100 mg every eight hours for three days. Group B received conventional treatment. Children 28 days of life to 18 years of age, of either sex, with the diagnosis of acute respiratory distress syndrome were included. The occurrence of adverse events, intensity, attitude followed after the appearance, outcome, and relationship between causality and mortality at day 28 were identified and quantified. Results: A total of 42 children were included: twenty children in group A and twenty-two ones in group B. In group A, 23 adverse events were reported in nine patients, while 97 adverse events were reported in 18 patients from group B. Hypertension was the most frequent adverse event. In group A, 73.9 % of adverse events of severe intensity were reported, 86.9 % remained unchanged after the administration of the drug, and 73.9 % had a remote causality with respect to the surfactant. Mortality at day 28 was 41.5 %; 20 % in group A, and 62 % in group B. Conclusions: Surfacen® was safe and well tolerated since a small number of adverse events related to its administration were reported.

Proteinosis alveolar pulmonar: reporte de caso en paciente con linfoma no hodgkin mesentérico / Pulmonary alveolar proteinosis: report of a case in patient with history of mesenteric non-hodgkin lymphoma

Objetivos: Exponer en base a un caso clínico una revisión de literatura reciente sobre Proteinosis alveolar pulmonar (PAP). Presentación del caso: Revisión de ficha clínica electrónica de paciente de sexo masculino de 76 años con antecedente de linfoma no Hodgkin (LNH) mesentérico, estirpe B de tipo folicular, quien acude en forma reiterada a servicios de urgencia por cuadro de dos meses de evolución de fiebre, compromiso del estado general y tos. Al examen físico destaca crépitos en hemitórax derecho. Se realizó Tomografía computada (TC) de tórax que mostró opacidades pulmonares en vidrio esmerilado periféricas, con engrosamiento septal liso y algunas bandas retráctiles subpleurales. Se manejó ambulatoriamente con Azitromicina por una semana. Sin respuesta, evoluciona con baja de peso y diaforesis nocturna. Nueva TC de tórax en enero 2021, muestra nuevos focos de "empedrado" periféricos extensos, descrito como "crazy paving", focos de vidrio esmerilado difusos extensos, sin condensación y con resolución de bandas retráctiles. Estudio infeccioso negativo. Se realiza lavado broncoalveolar (LBA) con estudio histológico de líquido que muestra proceso inflamatorio crónico con abundantes macrófagos y material proteináceo. Discusión: Tras el descarte de patología infecciosa, se orientó el estudio hacia otras causas de enfermedad parenquimatosa pulmonar. Así, resulta fundamental la descripción correcta del patrón imagenológico tomográfico y el LBA que resultaron compatibles con PAP. Conclusión: La PAP es una patología infrecuente, pero una historia clínica adecuada, el planteamiento de diagnósticos diferenciales de neumonía de lenta resolución, asociado el reconocimiento del patrón radiológico característico y el estudio histológico con LBA permiten realizar un diagnóstico certero, con gran implicancia terapéutica.

Objective: To present a review of recent literature on pulmonary alveolar proteinosis (PAP) based on a clinical case. Presentation of the case: Review of electronic clinical record of a 76 years-old masculine patient with history of mesenteric Non-Hodgkin Lymphoma (NHL) follicular-type lineage B, who repeatedly attended the emergency services due to a two-month history of symptoms of fever, compromised general condition and cough. Physical examination revealed crepitus in the right hemithorax. Chest computed tomography (CT) was performed, which showed peripheral ground-glass pulmonary opacities, with smooth septal thickening and some subpleural retractile bands. He was managed on an outpatient basis with Azithromycin for one week. No response; evolves with weight loss and night diaphoresis. New chest CT in January 2021, shows new extensive peripheral "cobblestone" foci, described as "crazy paving", extensive diffuse ground glass foci, without condensation and with resolution of retractile bands. Negative infectious study. Bronchoalveolar lavage (BAL) was performed with a histological study of the fluid showing a chronic inflammatory process with abundant macrophages and proteinaceous material. Discussion: After ruling out infectious pathology, the study was oriented towards other causes of pulmonary parenchymal disease. Thus, the correct description of the tomographic imaging pattern and the BAL that were compatible with PAP are essential. Conclusion: PAP is an infrequent pathology, but an adequate clinical history, the approach to differential diagnoses of slowly resolving pneumonia, associated with the recognition of the characteristic radiological pattern and the histological study with BAL allow an accurate diagnosis to be made, with great therapeutic implications.

Disfunción del transportador del surfactante pulmonar ABCA3: reporte de un caso peruano / Surfactant ABCA3 transporter dysfunction: a case report from Peru

Resumen Introducción: Los trastornos genéticos que afectan la homeostasis del surfactante pulmonar son una causa importante del síndrome de dificultad respiratoria en el recién nacido a término y de enfermedad pulmonar intersticial difusa en niños. El transportador ABCA3 (ATP binding cassette A3) interviene en la producción normal del surfactante que recubre el interior de las paredes alveolares y funciona como agente tensioactivo. Caso clínico: Recién nacido a término que presentó dificultad respiratoria a los 3 días de vida y requirió ventilación mecánica. Los estudios para determinar otras causas de enfermedad pulmonar fueron negativos. Se realizó una biopsia de pulmón para realizar estudios de microscopía óptica y microscopía electrónica. Esta última mostró pequeños cuerpos lamelares anómalos, además de condensaciones electrodensas periféricas, características de las mutaciones del transportador ABCA3. Se inició tratamiento con pulsos de metilprednisolona, hidroxicloroquina, azitromicina y corticoides inhalados a dosis altas, y la respuesta clínica y radiológica fue favorable durante el seguimiento. Conclusiones: La correlación de las características clínicas y de las imágenes (tomografía y microscopía electrónica) puede ser útil para el diagnóstico de la disfunción del surfactante pulmonar, especialmente en los países de bajos y medianos recursos que no disponen de estudios genéticos para determinar las diferentes mutaciones del transportador ABCA3. Este es uno de los primeros casos reportados en Perú con respuesta adecuada al tratamiento y evolución favorable durante el seguimiento.

Abstract Background: Genetic disorders affecting pulmonary surfactant homeostasis are a major cause of respiratory distress syndrome in full-term newborn and childhood interstitial lung disease. The ABCA3 transporter (ATP binding cassette A3) intervenes in the normal production of surfactant that covers the interior of alveolar walls and plays a fundamental role as a surfactant. Case report: Male term newborn who presented respiratory distress 3 days after birth and required mechanical ventilation. Studies to determine other causes of lung disease were negative. Lung biopsy was performed for the study with light microscopy and electron microscopy. Electron microscopy showed small abnormal lamellar bodies in addition to peripheral electrodense condensations characteristic of ABCA3 transporter mutation. Treatment was started with pulses of methylprednisolone, hydroxychloroquine, azithromycin, and high-dose inhaled corticosteroids, finding a favorable clinical and radiological response to follow-up. Conclusions: Correlation of clinical characteristics and images (tomography and electron microscopy) can be useful for the diagnosis of lung surfactant dysfunction, especially in low and medium-income countries where genetic studies to determine the different ABCA3 transporter mutations are not available. This is one of the first cases reported in Peru with an adequate response to treatment and favorable evolution to follow-up.

Retratamento com surfactante em prematuros de muito baixo peso: preditores de risco e sua influência nos resultados neonatais / Retreatment with surfactant in very low birth weight preterm infants: risk predictors and their influence on neonatal outcomes

ABSTRACT Objective: To assess clinical predictors and outcomes associated to the need for surfactant retreatment in preterm infants. Methods: Retrospective cohort study, including very low birth weight preterm infants from January 2006 to December 2015 who underwent surfactant replacement therapy. Beractant was used (100 mg/kg), repeated every six hours if FiO2 ≥0.40. The subjects were classified into two groups: single surfactant dose; and more than one dose (retreatment). We evaluated maternal and neonatal predictors for the need of retreatment and neonatal outcomes associated to retreatment. Results: A total of 605 patients (44.5%) received surfactant; 410 (67.8%) one dose, and 195 (32.2%) more than one dose: 163 (83.5%) two doses and 32 (16.4%) three doses. We could not find clinical predictors for surfactant retreatment. Retreatment was associated to a greater chance of BPD in infants >1000 g (RR 1.78; 95%CI 1.30‒2.45) and ≤1000 g (RR 1.33; 95%CI 1.04‒1.70), in infants with gestational age<28 weeks (RR 1.56; 95%CI 1.12‒2.18) and ≥28 weeks (RR 1.50; 95%CI 1.17‒1.92), in neonates with early sepsis (RR 1.48; 95%CI 1.20‒1.81), and in infants not exposed to antenatal corticosteroids (RR 1.62; 95%CI 1.20‒2.17) Conclusions: We could not find predictor factors associated to surfactant retreatment. The need for two or more doses of surfactant was significantly related to bronchopulmonary dysplasia.

RESUMO Objetivo: Avaliar preditores clínicos e resultados associados à necessidade de retratamento com surfactante. Métodos: Coorte retrospectiva com prematuros de muito baixo peso, no período de janeiro de 2006 a dezembro de 2015, em uso de terapia de reposição de surfactante. O surfactante utilizado foi beractante (100 mg/kg), repetido a cada seis horas se FiO2≥0.40. Foram analisados dois grupos: dose única de surfactante e mais de uma dose (retratamento). Foram avaliados preditores maternos e neonatais para retratamento e resultados neonatais. Resultados: 605 pacientes (44,5%) receberam surfactante; 410 (67,8%) uma dose e 195 (32,2%) mais de uma dose: 163 (83,5%) duas doses e 32 (16.4%) três doses. Não foram encontrados fatores associados ao retratamento com surfactante. A displasia broncopulmonar (DBP) foi associada ao retratamento (p<0.01). A presença de retratamento aumentou a chance de ocorrência de DBP em neonatos >1000 g (RR 1,78; IC95% 1,30‒2,45) e ≤1000 g (RR 1,33; IC95% 1,04‒1,70), em recém-nascidos com idade gestacional <28 semanas (RR 1,56; IC95% 1,12‒218) e ≥28 semanas (RR 1,50; IC95% 1,17‒1,92), naqueles com sepse precoce (RR 1,48; IC95% 1,20‒1,81), e nos que não foram expostos ao corticoide antenatal (RR 1,62; IC95% 1,20‒2,17). Conclusões: Não encontramos fatores preditores associados à necessidade de retratamento. A necessidade de duas ou mais doses de surfactante está associada à displasia broncopulmonar.

Surfactant in SARS-CoV-2 ­ a therapeutic option based on underlying lung cell damage? / Surfactante em SARS-CoV-2 ­ uma opção terapêutica baseada no dano celular subjacente aos pneumócitos?

Introduction: the severe acute respiratory syndrome ­ coronavirus 2 (SARS Cov-2), leads to a diffuse alveolar deterioration due infection of type II pneumocytes. The type II pneumocytes are involved in synthesis and secretion of pulmonary surfactant in pulmonary alveoli. Objective: the purpose of this study is to discuss the indication of surfactant replacement as a potential adjunctive treatment modality for SARS CoV-2, similarly treatment to neonatal respiratory distress syndrome. Methodology: we argue that SARS can be triggered by surfactant deficiency secondary to production deficiency determined by type 2 pneumocyte injuries. In this sense, we carried out a bibliographic review. Conclusion: thus, the replacement of human surfactant could be a potential treatment modality for SARS CoV-2, in the same way that it is indicated for the treatment of neonatal respiratory distress syndrome.

Introdução: a síndrome respiratória aguda grave ­ coronavírus 2 (SARS Cov-2), leva a uma deterioração alveolar difusa devido à infecção do pneumócitos tipo II. Os pneumócitos tipo II estão envolvidos na síntese e secreção de surfactante pulmonar nos alvéolos pulmonares. Objetivo: o objetivo deste estudo é discutir a indicação de reposição de surfactante como uma potencial modalidade de tratamento adjuvante para SARS CoV-2, similarmente ao tratamento da síndrome do desconforto respiratório neonatal. Metodologia: argumentamos que a SARS pode ser desencadeada pela deficiência de surfactante, secundária à deficiência da sua produção determinada por lesões de pneumócitos tipo 2. Nesse sentido, realizamos uma revisão bibliográfica. Conclusão: o uso de surfactante humana pode ser uma potencial modalidade de tratamento para a SARS CoV-2, da mesma forma que é indicada para o tratamento da síndrome do desconforto respiratório neonatal.

Dolor y variabilidad de la frecuencia cardíaca en recién nacidos prematuros que recibieron surfactante: un estudio piloto / Neonatal pain and heart rate variability in preterm infants treated with surfactant: a pilot study

Objetivo. Evaluar la percepción del dolor de recién nacidos prematuros a quienes se les administró surfactante mediante diferentes técnicas, utilizando la variabilidad de la frecuencia cardíaca (VFC).Métodos. Se aleatorizó a los recién nacidos que requirieron tratamiento con surfactante por SDR a los grupos INSURE o MIST. El análisis de la VFC se realizó con la tecnología NIPE para evaluar el componente parasimpático del sistema nervioso autónomo de los recién nacidos. Se registró la VFC antes, durante y después de administrar el surfactante. La evaluación del dolor se determinó con la escala PIPP. Resultados. Se incluyó a 14 recién nacidos en el estudio. Los grupos tenían características demográficas similares. Los puntajes de la escala PIPP no difirieron entre los grupos INSURE y MIST (p = 0,05). Se observó una diferencia estadísticamente significativa en la mediana de la VFC durante la administración del surfactante entre los grupos INSURE y MIST (52 frente a 56, p = 0,03). El análisis de la VFC fue similar entre los grupos antes y después de administrar el surfactante.Conclusión. La administración de surfactante mediante la técnica MIST podría ser más cómoda para los recién nacidos prematuros con SDR. No obstante, es necesario realizar otros estudios con series más importantes.

Objective. We aimed to assess the pain perception of preterm infants treated with different surfactant administration techniques by using heart rate variability (HRV).Methods. Preterm infants who required surfactant therapy for RDS were randomized to INSURE or MIST groups. HRV analysis was performed by Newborn Infant Parasympathetic Evaluation monitor. HRV was recorded before, during and after surfactant administration. Pain assessment was determined by Premature Infant Pain Profile (PIPP) score.Results. Fourteen infants were enrolled in the study. Demographic characteristics of the groups were similar. PIPP scores did not differ between INSURE and MIST groups (p = 0.05). Statistically significant difference in median HRV during surfactant administration was observed between INSURE and MIST groups (52 vs. 56, p = 0.03). HRV analysis was similar between groups before and after surfactant administration. Conclusion. Surfactant administration with MIST technique might be more comfortable for preterm infants with RDS. However further studies with larger series are needed.

Rapid diagnosis of respiratory distress syndrome by oral aspirate in premature newborns / Diagnóstico rápido da síndrome do desconforto respiratório por aspirado bucal em recém-nascidos prematuros

Abstract Objective: The stable microbubble test on gastric aspirate and on amniotic fluid has been used for the diagnosis of respiratory distress syndrome in the newborn. However, no study has performed this test on oral aspirates from premature infants. The objective of this study was to evaluate the performance of the stable microbubble test on oral aspirates from preterm newborns to predict respiratory distress syndrome. Method: This study included infants with gestational age <34 weeks. Oral fluids were obtained immediately after birth and gastric fluids were collected within the first 30 minutes of life. The samples were frozen and tested within 72 hours. Results: The sample was composed of paired aspirates from 64 newborns, who were divided into two groups: respiratory distress syndrome group (n = 21) and control group (n = 43). The median (interquartile range) of the stable microbubble count in the oral samples of infants with respiratory distress syndrome was significantly lower than that of infants who did not develop respiratory symptoms: respiratory distress syndrome group = 12 (8 -22) stable microbubbles/mm2; control group = 100 (48 -230) microbubbles/mm2 (p < 0.001). The correlation between microbubble count in gastric and oral aspirates was 0.90 (95% confidence interval = 0.85 -0.95; p < 0.001). Considering a cut-off point of 25 microbubbles/mm2, the sensitivity and the specificity of the stable microbubble test were 81.4% and 85.7%, respectively. Conclusion: The study suggests that the stable microbubble test performed on oral aspirate is a reliable alternative to that performed on gastric fluid for the prediction of respiratory distress syndrome in the newborn.

Resumo Objetivo: O teste das microbolhas estáveis no aspirado gástrico e no líquido amniótico foi usado no diagnóstico da síndrome do desconforto respiratório do recém-nascido. Contudo, nenhum estudo fez esse teste nos aspirados bucais de neonatos prematuros. O objetivo deste estudo foi avaliar o desempenho do teste das microbolhas estáveis em aspirados bucais de recém-nascidos prematuros para prever síndrome do desconforto respiratório. Método: Este estudo incluiu neonatos com idade gestacional < 34 semanas. Os fluidos orais foram obtidos imediatamente após o nascimento e os fluidos gástricos foram coletados nos primeiros 30 minutos de vida. As amostras foram congeladas e testadas em 72 horas. Resultados: A amostra foi composta de aspirados pareados de 64 recém-nascidos, divididos em dois grupos: grupo de síndrome do desconforto respiratório (n = 21) e grupo de controle (n = 43). A mediana (intervalo interquartil) da contagem das microbolhas estáveis nas amostras de fluido oral dos neonatos com síndrome do desconforto respiratório foi significativamente menor que a dos neonatos que não desenvolveram sintomas respiratórios: grupo de síndrome do desconforto respiratório = 12 (8-22) microbolhas estáveis/mm2; grupo de controle = 100 (48-230) microbolhas/mm2 (p < 0,001). A correlação entre a contagem das microbolhas nos aspirados gástricos e bucais foi 0,90 (intervalo de confiança de 95% = 0,85-0,95; p < 0,001). Considerando um ponto de corte de 25 microbolhas/mm2, a sensibilidade e a especificidade do teste das microbolhas estáveis foram 81,4% e 85,7%, respectivamente. Conclusão: O estudo sugere que o teste das microbolhas estáveis feito no aspirado bucal é uma opção confiável ao fluido gástrico para a predição da síndrome do desconforto respiratório do recém-nascido.

Proteinosis alveolar pulmonar / Pulmonary alveolar proteinosis an update

La Proteinosis Alveolar Pulmonar (PAP) es una enfermedad poco frecuente, caracterizada por la acumulación de material lipoproteico derivado del surfactante pulmonar al interior de los alvéolos por una falla de depuración de este material por los macrófagos alveolares, siendo la causa más frecuente de esta disfunción la acción bloqueadora producida por anticuerpos anti factor estimulante de colonias de granulocitos y macrófagos (GM-CSF) lo que lleva a un deterioro del intercambio gaseoso. La evolución es variable abarcando desde la resolución espontánea hasta la insuficiencia respiratoria grave y la muerte. Se describen tres formas de PAP: Genética, secundaria y autoinmune (antes primaria o idiopática) siendo esta última la más frecuente en adultos. Clínicamente, se manifiesta por disnea, tos seca e hipoxemia que pueden ser progresivas. En la radiografía de tórax se encuentran opacidades bilaterales y la tomografía computarizada de tórax de alta resolución (TACAR) muestra vidrio esmerilado con sobre posición de engrosamiento septal intra e interlobulillar, patrón conocido como "crazy paving". El diagnóstico se basa en la clínica y en el lavado broncoalveolar con material PAS positivo. La biopsia quirúrgica es confirmatoria. El tratamiento clásico es el lavado pulmonar total (LPT) para remover el contenido alveolar. Otras alternativas son la administración de GM-CSF subcutáneo o inhalado, plasmaferesis y rituximab, cuyos resultados son variables. Diferentes autores han modificado la forma del LPT y combinado los diferentes métodos de tratamiento con el fin de obtener resultados más rápidos y efectivos.

Pulmonary Alveolar Proteinosis (PAP) is a rare disease characterized by the accumulation of surfactant derived lipoproteinaceous material filling the alveoli, secondary to failure of its clearance by macrophages. Most of the patients are adults that have auto antibodies directed to Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF). The evolution is towards disturbed gaseous exchange with a wide spectrum of disease from spontaneous recovery to death. There are three forms of PAP: genetic, secondary and autoimmune. Symptoms are scarce and patients may present with dyspnea, dry cough and hypoxemia. Chest X ray shows bilateral opacities and thorax CT depicts ground glass opacities surrounded by septal widening, the so called "crazy paving" pattern. Diagnosis is made on clinical and radiological grounds and confirmed by PAS positive staining of bronchoalveolar lavage material or surgical lung biopsy. Accepted treatment is whole lung lavage (WLL) with saline. Alternatives are subcutaneous or inhaled GM-CSF, Plasmapheresis or Rituximab, and even modification of the method of WLL and combination of different manner of treatment.

A randomized controlled trial of the laryngeal mask airway for surfactant administration in neonates / Ensaio controlado randomizado de máscara laríngea para administração de surfactantes em neonatos

Abstract Objective: To compare the short-term efficacy of surfactant administration by laryngeal mask airway versus endotracheal tube. Methods: Preterm infants (28-35 weeks of gestational age), weighing 1 kg or more, with respiratory distress syndrome, requiring nasal continuous positive airway pressure, with increased respiratory effort and/or fraction of inspired oxygen (FiO2) ≥ 0.40 to maintain oxygen saturation 91-95%, were randomized to receive surfactant by LMA following nCPAP or by ETT following mechanical ventilation (MV). The primary outcome was a clinical response defined as FiO2 ≤ 0.30 three hours after surfactant. Secondary outcomes for LMA group were: need of surfactant retreatment during the first 24 h, MV requirement, and presence of surfactant in gastric content. Results: Forty-eight patients were randomized; 26 in the LMA group and 22 in the ETT group. Six of 26 patients (23%) in the LMA group and five of 22 patients (22.7%) in the ETT group did not meet the primary outcome (p = 0.977). Fourteen (53.8%) of the LMA patients were not intubated nor ventilated; 12 (46.1%) were ventilated: for surfactant failure (23%), for nCPAP failure (11.5%), and for late complications (11.5%). Groups were similar regarding prenatal status, birth conditions, and adverse events. No significant gastric content was found in 61.5% of the LMA patients. Oxygen and second dose surfactant requirements, arterial/alveolar ratio, and morbidities were similar among groups. Conclusions: Surfactant administration by LMA showed short-term efficacy, with similar supplementary oxygen need compared to surfactant by ETT, and lower MV requirement. Further studies with larger sample size are necessary to confirm these results.

Resumo Objetivo: Comparar a eficácia de curto prazo da administração de surfactante por máscara laríngea em comparação com o tubo endotraqueal. Métodos: Neonatos prematuros (28-35 semanas de idade gestacional), com 1 kg ou mais, com síndrome do desconforto respiratório, que necessitavam de pressão positiva nasal contínua nas vias aéreas, com aumento do esforço respiratório e/ou fração de oxigênio inspirado (FiO2) ≥ 0,40 para manter a saturação de oxigênio 91-95%, foram randomizados para receber surfactante por ML seguido por nCPAP ou por TE seguido por ventilação mecânica (VM). O resultado clínico primário foi definido como FiO2 ≤ 0,30 três horas após o surfactante. Os resultados secundários do grupo de ML foram: necessidade de segunda dose de surfactante nas primeiras 24 horas, necessidade de VM e presença de surfactante no conteúdo gástrico. Resultados: Foram randomizados 48 pacientes; 26 no grupo de ML e 22 no grupo de TE. Seis dentre os 26 pacientes (23%) do grupo de ML e cinco dentre 22 pacientes (22,7%) do grupo de TE não apresentaram o resultado primário (p = 0,977); 14 (53,8%) dos pacientes do grupo de ML não foram intubados nem ventilados; 12 (46,1%) foram submetidos a VM: por falha do surfactante (23%), por falha da nCPAP (11,5%) e por complicações tardias (11,5%). Os grupos foram semelhantes em relação às condições pré-natais e de nascimento e a ocorrência de eventos adversos. Não foi encontrado conteúdo gástrico significativo em 61,5% dos pacientes do grupo de ML. As necessidades de oxigênio e da segunda dose de surfactante, o índice arterial/alveolar e as morbidades foram semelhantes entre os grupos. Conclusões: A administração de surfactante por ML mostrou eficácia de curto prazo com necessidade complementar de oxigênio semelhante ao surfactante por TE e menor necessidade de VM. Serão necessários estudos adicionais com tamanho da amostra maior para confirmar esses resultados.

Madurez pulmonar fetal: evaluación ecográfica, ¿es confiable?

El objetivo de la presente comunicación es revisar la importancia del tema de la madurez fetal mediante procedimientos no invasivos empleando los ultrasonidos en sus variantes de flujometria Doppler y escala de grises. Los autores destacan la importancia de precisar con la mayor exactitud el grado de madurez pulmonar alcanzada por el feto a la hora de tomar la decisión de interrumpir la gestación por diversas indicaciones. Todo ello con la finalidad de evitar las consecuencias de la prematuridad que incluyen el síndrome de dificultad respiratoria (SOR) del recién nacido ocasionado por la ausencia de surfactante pulmonar que pudiera inclusive llevarlo a la muerte. Coinciden los autores en que se trata de un diagnóstico multiparamétrico que tiene como punto de partida el cálculo de la edad gestacional a partir de un primer estudio ultrasonográfico realizado entre las 5 y 10 semanas, luego la evaluación de la impedancia vascular del lecho pulmonar por medio del Doppler, acompañado de otros parámetros tales como la madurez intestinal, el grado de corticalización cerebral, la presencia de núcleos de osificación, la edad biométrica fetal actual y la estimación del peso. Concluyen enfatizando que ante la duda y la existencia de un feto sano, con crecimiento adecuado, perfil biofísico y hemodinámico normal, la conducta más sensata es la de esperar la culminación de la gestación según los nuevos criterios que redefinen la duración del embarazo y que han sido propuestos por la ACOG.

The purpose of this communication is to review the importance of fetal maturity determination by non-invasive procedures using ultrasound Doppler velocimetry and grayscale. The authors emphasize the importance of precisely specifying fetal lung maturity when deciding to terminate pregnancyfor various indications in order to avoid consequences of prematurity including newborn's respiratory distress syndrome (ROS) due to absence of lung su rfactant that could lead even to death. The authors coincide that a multiparameter diagnosis of gestational age calculation starts from a first ultrasound study between 5 and 10 weeks, assessment of lung vascular impedance by Doppler accompanied by intestinal maturity, degree of cerebral corticalization, presence of nuclei ossification, current biometric fetal age and estimation of weight. They conclude emphasizing that in doubt and presence of a healthy fetus, with good growth, and normal hemodynamic biophysical profile, the more sensible course is to wait for the completion of gestation according to new criteria that redefine the duration of pregnancy and has been proposed by the ACOG.

Actualización en la evaluación de la madurez pulmonar fetal por ultrasonido

El síndrome de dificultad respiratoria (SDR) del recién nacido persiste como una de las principales causas de morbilidad y mortalidad en neonatos prematuros. A pesar que la evidencia científica reciente cuestiona la utilidad de las pruebas para evaluar la madurez pulmonar fetal para determinar el momento más adecuado para el parto en ciertas complicaciones obstétricas, existe un conjunto de indicaciones relativas en las cuales una prueba no invasiva puede encontrar aplicación. El objetivo del presente trabajo es revisar los trabajos publicados en la literatura sobre el empleo de la ecografía como método para predecir la morbilidad respiratoria neonatal, utilizando la evaluación Doppler de la arteria pulmonar y el análisis cuantitativo de la textura ecográfica del pulmón fetal.

Respiratory distress syndrome (RDS) of the newborn remains a major cause of morbidity and mortality in preterm infants. Although the latest scientific evidence questions the utility of fetal lung maturity testing to determine the most suitable moment for delivery in certain obstetrical complications, there is a set of relative indications in which a non-invasive test can find application. The aim ofthis paper is to review studies published on the use of ultrasound as a method to predict neonatal respiratory morbidity, using both Doppler evaluation ofthe pulmonary artery and ultrasound quantitative analysis of fetallung texture.

Comparing the effects of minimal handling protocols on the physiological parameters of preterm infants receiving exogenous surfactant therapy / Comparação dos efeitos de protocolos de manuseio mínimo em parâmetros fisiológicos de prematuros submetidos à terapia de surfactante exógeno

BACKGROUND: The practice of minimal handling is recommended for preterm infants (PTIs). However, few studies have investigated the effects of this practice among these infants or the time needed to ensure greater physiological stability, especially after exogenous surfactant treatments. OBJECTIVE: The current study compared the effects of two protocols of minimal handling on the physiological variables of PTIs after surfactant therapy. METHOD : An exploratory prospective observational study was performed with 40 PTIs weighing less than 1,500 g. The infants were divided into two groups and monitored for 72 hours. One group received the standard minimal handling procedure during the first 12 hours after surfactant therapy; the other group (i.e., the modified group) received minimal handling within 72 hours after surfactant therapy. Infant heart rate (HR), oxygen saturation, body temperature, and the adverse events associated with changes to these variables were monitored every 10 minutes. RESULTS : Significant between-group differences were not found with regard to the occurrence of the adverse events associated with physiological changes (p>0.05). CONCLUSION: The practice of minimal handling among very low birth weight infants did not alter their physiological stability when performed either 12 or 72 hours after surfactant therapy. .

CONTEXTUALIZAÇÃO: A prática de manuseio mínimo é recomendada a recém-nascidos pré-termo. Contudo, há escassez de estudos, na literatura, sobre os efeitos da utilização dessa prática nesses recém-nascidos e sobre o tempo necessário para garantir maior estabilidade fisiológica a eles, principalmente após terapia com surfactante exógeno. OBJETIVO: Comparar o efeito de dois protocolos de manuseio mínimo em variáveis fisiológicas de recém-nascidos pré-termo após terapia com surfactante. MÉTODO: Foi realizado um estudo observacional prospectivo exploratório com 40 recém-nascidos, menores que 1500g, distribuídos em dois grupos que foram monitorizados e seguidos durante 72 horas. Um grupo permaneceu em manuseio mínimo padrão durante as primeiras 12 horas após surfactante; o outro grupo, denominado grupo modificado, ficou em manuseio mínimo por 72 horas após surfactante. As variáveis de frequência cardíaca, saturação periférica de oxigênio e temperatura axilar e eventos adversos associados a essas variáveis foram monitorados de dez em dez minutos. RESULTADOS: Não houve diferenças significativas na ocorrência de eventos adversos associados às variáveis estudadas, entre os grupos, em relação ao tempo de manuseio mínimo (p>0,05). CONCLUSÃO: A prática de manuseio mínimo em recém-nascidos de muito baixo peso não alterou a estabilidade fisiológica quando executada durante 12 horas ou 72 horas após administração surfactante. .

High postoperative serum levels of surfactant type B as novel prognostic markers for congenital heart surgery / Níveis séricos pós-operatórios tipo surfactante B elevados como novos marcadores prognósticos para cirurgia cardíaca congênita

Objective: Congenital heart diseases are observed in 5 to 8 of every 1000 live births. The presence of a valuable biomarker during the surgical periods may aid the clinician in a more accurate prognosis during treatment. Methods: For this reason, surfactant protein B plasma levels may help to evaluate patients with cardiac problems diminishing the alveolocapillary membrane stability. In this study, plasma levels of this biomarker were measured in the preoperative and postoperative periods. This study was conducted to detect the differences between pulmonary hypertensive and normotensive patients. The differences before and after cardiopulmonary bypass were examined. Results: The differences in cardiopulmonary bypass time, cross-clamp time , inotropic support dose, and duration of intensive care of patients with and without pulmonary hypertensive were found to be statistically significant (P<0.05). The results revealed that this pathophysiological state was related to other variables that were studied. We believe that the differences in preoperative and postoperative SPB levels could be attributed to alveolocapillary membrane damage and alveolar surfactant dysfunction. We found that this pathophysiological condition was significantly associated with postoperative parameters. Conclusion: The findings of the current study showed that surfactant protein B was present in the blood of patients with a congenital heart disease during the preoperative period. Long by-pass times may exert damage to the alveolocapillary membrane in patients with pulmonary hypertension and preoperative heart failure, and it is recommended to keep the option of surfactant therapy in mind during the postoperative course at the intensive care unit before preparing the patients for extubation. .

Objetivo: As cardiopatias congênitas são observadas em 5 a 8 em cada 1.000 nascidos vivos. A presença de um biomarcador importante durante os períodos cirúrgicos pode auxiliar o clínico a um prognóstico mais preciso durante o tratamento. Métodos: Por esta razão, os níveis plasmáticos de proteína B do surfactante podem ajudar a avaliar os pacientes com problemas cardíacos, diminuindo a estabilidade da membrana alvéolo-capilar. Neste estudo, os níveis plasmáticos deste biomarcador foram medidos nos períodos pré-operatório e pós-operatório. Este estudo foi realizado para detectar as diferenças entre pacientes hipertensos e normotensos em nível pulmonar. As diferenças antes e depois da circulação extracorpórea foram examinadas. Resultados: As diferenças no tempo de circulação extracorpórea, tempo de pinçamento, a dose de drogas vasoativas, e a duração da terapia intensiva de pacientes com e sem hipertensão pulmonar foram estatisticamente significativas (P<0,05). Os resultados revelaram que este estado fisiopatológico foi relacionado a outras variáveis que foram estudadas. Acreditamos que as diferenças nos níveis de SPB pré-operatório e pós-operatório pode ser atribuída a danos na membrana alvéolo-capilar e disfunção do surfactante alveolar. Descobrimos que esta condição fisiopatológica foi significativamente associada com parâmetros pós-operatórios. Conclusão: Os resultados do estudo mostraram que a proteína B surfactante estava presente no sangue de pacientes com doença cardíaca congênita no pré-operatório. Longos tempos de circulação extracorpórea podem exercer danos na membrana alvéolo-capilar em pacientes com ...

Metodología para elaborar el Plan Maestro de Validación de los procesos de producción del Centro Nacional de Sanidad Agropecuaria / Methodology to design the Master Plan of Validation of production processes of National Center of Agricultural Health

La metodología para la elaboración del Plan Maestro de Validación de los procesos de producción del Centro Nacional de Sanidad Agropecuaria, se diseñó a partir de los requisitos contenidos en la Regulación 16 del 2006 de Buenas Pràcticas de Fabricación de medicamentos. Abarcó la política de la organización para la actividad de validación su estructura organizativa, las instalaciones, sistemas, equipos y procesos que se deben validar; el formato de la documentación a utilizar; la planificación y calendario de cada actividad; los resultados de cada protocolo ejecutado, el control de los cambios que se generan; un resumen de las validaciones anteriores; cumplimiento del plan propuesto; las conclusiones donde se precisan de forma resumida si los procesos validados estàn bajo control, los resultados màs relevantes, así como las acciones correctivas y preventivas a tomar; por último se define la distribución de toda la información generada, conformando así el Plan Maestro de Validación. Este sistema de validación se muestra a través de procedimientos, protocolos y registros aplicados en el proceso de fabricación de Surfacen®, medicamento para uso humano que se fabrica en el Centro Nacional de Sanidad Agropecuaria.

The methodology to design the Validation Master Plan the production processes of National Center of Agricultural Health was created from the requirements present in the Regulation 16, 2006 of Good Practices of drugs manufacture including the organization policy for validation activity of its organizing structure, installations, systems, equipments and processes to be validated, documentation format used, planning and calendar of each activity; the results from each protocol performed, the generating changes control, abstract of prior validations, fulfillment of proposed plan, conclusions where are determined in a summarized way if the validated processes are under control, the more relevant results, as well as how the corrective and preventive actions executed, and lastly, the distribution of all the generated information is defined, thus creating the validation of Master Plan. This validation system is showed thorough procedures, protocols and registries applied in manufacturing process of Surfacen® a human use drug manufactured in the National Center of Agricultural Health.

Validación de puntos críticos de la producción de Surfacen / Validation of critical features of Surfacen production

El Surfacen® es un medicamento utilizado en el tratamiento del síndrome de dificultad respiratorio del recién nacido, causa importante de mortalidad y morbilidad neonatal. Este se fabrica en el Centro Nacional de Sanidad Agropecuaria (La Habana, Cuba) bajo un Sistema de Gestión de la Calidad y Buenas Prßcticas de Fabricación. El pulmón porcino constituye la materia prima fundamental, y es a partir de su calidad microbiológica y la del proceso productivo que se garantiza un producto final libre de contaminantes microbianos y de pirógenos. A partir del dise±o de protocolos específicos y de las regulaciones existentes se demostró que la crianza de cerdos, su proceso de sacrificio y los materiales utilizados en la obtención de los lavados pulmonares, permiten alcanzar una calidad microbiológica definida y bajo control. El proceso de producción fue capaz de eliminar la carga microbiana presente en los lavados pulmonares que junto al resto de las operaciones de preparación de materiales estériles, su traslado, uso, al igual que la limpieza y desinfección de las ßreas limpias, el llenado aséptico y el personal garantizaron la esterilidad del producto final. Todos estos resultados permiten concluir que los procesos críticos de la producción de Surfacen® estßn validados y garantizan que este sea estéril, libre de pirógenos y sin residuales tóxicos, lo que demuestra su seguridad, reproducibilidad y consistencia.

Surfacen® is a drug used in treatment of newborn respiratory distress syndrome, a significant cause of neonatal mortality and morbidity. This drug is manufactured by National Center of Farming and livestock Hygiene (La Habana, Cuba) under a Management System of Quality and Good Practices of Manufacture. Pig lung is the essential raw material, and it is from microbiologic quality and that of productive process, that a free of microbial contaminant and pyrogen end product is guaranteed. From design of specific protocols and of the available regulations, it was demonstrated that pig breeding, its sacrifice process, and materials used in achievement of lung lavages, allow us to obtain a defined microbiologic quality and under control. Production process was able to eliminate microbial charge present in lung lavages, which together with the remainder preparation tasks of sterile materials, its transfer, use, as well as cleaning and disinfection of clean areas, the aseptic filling, and staff guaranteed sterility of end product. All these results allow us to conclude that the critical processes of Surfacen® production are validated and guarantee that this one be sterile, pyrogen-free, and without toxic residuals, demonstrating its safety, reproducibility and consistence.

Relación entre mecanismos involucrados y dianas terapéuticas en el síndrome de dificultad respiratoria agudo / Association between involved mechanisms and therapeutic targets in the acute respiratory distress syndrome

El surfactante pulmonar constituye un sistema multicomponente de vital importancia para la respiración de los organismos pulmonados. Su afectación se asocia al desarrollo de enfermedades respiratorias de diversas gravedades, siendo el síndrome de dificultad respiratoria agudo uno de los problemas de salud no resueltos a nivel mundial. El presente artículo revisa el estado actual del conocimiento de este síndrome, se incluye su definición, etiología, epidemiología, factores que lo determinan con especial énfasis en los mecanismos inflamatorios/oxida-tivos involucrados, fundamentalmente en la enzima fosfolipasa A2 de secreción así como las perspectivas en la investigación en cuanto a la búsqueda de medicamentos más eficaces para su tratamiento.

Pulmonary surfactant is one multi-component system of vital importance for breathing of organisms with lungs. When this surfactant is negatively affected, this is associated with the development of respiratory diseases with several degrees of severity, being the acute respiratory distress syndrome one of the unsolved health problems worldwide. The present article reviews the present situation of knowledge about this syndrome including definition, etiology, epidemiology, determining factors, making special emphasis on inflammatory/oxidative mechanisms involved, mainly secretory A2 phospholipase enzyme, as well as the research prospects around search of more efficient drugs to treat this condition.

Después de medio siglo de estudio del sistema surfactante pulmonar / After half a century of studying the pulmonary surfactant system

Se examinó la historia y el estado actual del conocimiento sobre el sistema surfactante pulmonar endógeno, enfatizando en la composición bioquímica y sus funciones biológicas al nivel pulmonar; así como en las fuentes y vías de obtención de los surfactantes exógenos; algunos productos que han logrado introducirse con éxito en la práctica clínica y otros que están en fases avanzadas de su ciclo de obtención y evaluación. Aborda las metas de la investigación en este campo.

The history and present state of the knowledge about the endogenous pulmonary surfactant system was examined, making emphasis on the biochemical composition and its biological functions at the lung level, as well as on the sources and ways of obtention of the exogenous surfactants, on some products that have been successfully introduced into the medical practice and on others that are at advanced stages of their cycle of obtention and evaluation. It also approaches the goals of research in this field.

Estudio controlado del tratamiento de la enfermedad de membrana hialina del recién nacido pretérmino con surfactante pulmonar exógeno (porcino vs. bovino) / Treatment of hyaline membrane disease in the preterm newborn with exogenous lung surfanctant. A controlled study

Introducción: La enfermedad de membrana hialina (EMH) por deficiencia de surfactante pulmonar en el neonato prematuro es una causa importante de morbimortalidad. El surfactante pulmonar exógeno ha revolucionado el tratamiento de esta entidad en países desarrollados, aunque este beneficio ha sido menor en países en vías de desarrollo. El surfactante porcino de manufactura cubana es económico, y su uso comparado con otros surfactantes es desconocido. Material y métodos: Se llevó a cabo un estudio prospectivo, controlado, aleatorizado, abierto, en 44 recién nacidos prematuros con EMH. Un grupo recibió surfactante bovino (SB) (Survanta), y el otro surfactante porcino (SP) de fabricación cubana (Surfacen). Se evaluó la respuesta en variables de oxigenación y ventilación, días de oxígeno suplementario, ventilación mecánica, incidencia de complicaciones, tiempo de hospitalización y mortalidad. Resultados: 23 pacientes recibieron el surfactante bovino, y 21 el porcino. Los dos grupos fueron similares clínicamente y en sus patrones de respuesta de oxigenación y ventilación, con una tendencia a mayor incremento inicial en la oxigenación en el grupo tratado con SP. La incidencia de complicaciones fue similar en los dos grupos. Fallecieron 10 pacientes (47.6%) en el grupo SP, y 12 (52.2%) en el grupo SB (p>0.05). Conclusiones: El surfactante porcino tuvo efectos clínicos similares al bovino en las variables de oxigenación y ventilación estudiadas; no hubo diferencia significativa en complicaciones y mortalidad. El surfactante porcino es una alternativa efectiva y de menor costo que el surfactante bovino para el tratamiento de la EMH.

Background: Hyaline membrane disease (HMD) due to lung surfactant deficiency in the preterm newborn is an important cause of neonatal morbidity and mortality. Exogenous lung surfactant has transformed HMD therapy in developed countries, but an equivalent benefit has not been accomplished in developing countries due to a variety of factors. Porcine surfactant developed in Cuba is an inexpensive alternative to other surfactants, and its use has not been studied in our settings. Methods: A randomized, open, prospective and controlled trial was undertaken in 44 preterm newborns with HMD diagnosis. One group received bovine surfactant (BS) (Survanta) and the other Cuban porcine surfactant (PS) (Surfacen). The following clinical response variables were evaluated: oxygenation and ventilation indexes, days with supple mentary oxygen, days with mechanical ventilation, incidence of compli cations, time of hospitalization, and mortality. Results: 23 Patients received bovine surfactant and 21 the porcine type. The two groups were clinically similar, with patterns of oxygenation and ventilation response that were the same between groups, with a tendency to higher initial oxygenation increase in the PS group. The incidence of complications was similar between groups. Ten Patients (47.6%) died in the PS group, versus 12 (52.2%) in the BS group (p>0.05) Conclusions: Porcine surfactant had similar clinical effects than bovine surfactant in the oxygenation and ventilation variables, with no significant differences in complications or mortality. Porcine surfactant is an effective and lower cost alternative to bovine surfactant in the treatment of HMD.