Clinical outcomes after more conservative management of patent ductus arteriosus in preterm infants / Desfechos clínicos após tratamento mais conservador da persistência do canal arterial em prematuros

Abstract Objective: Management of patent ductus arteriosus is still controversial. This study aimed to describe the impact of a more conservative approach on treatment rates and on main outcomes of prematurity, especially in preterm infants with <26 weeks of gestation. Method: Clinical charts review of infants ≤30 weeks with patent ductus arteriosus between 2009 and 2016 at two centers. In 2011, the authors changed patent ductus arteriosus management: in first period (2009-2011), patients who failed medical treatment underwent surgical closure; in second period (2012-2016), only those with cardiopulmonary compromise underwent surgical ligation. Medical treatment, surgical closure, mortality, and survival-without-morbidity were compared. Results: This study included 188 patients (27 ± 2 weeks, 973 ± 272 grams); 63 in P1 and 125 in P2. In P2, significantly lower rates of medical treatment (85.7% P1 versus 56% P2, p < 0.001) and surgical closure (34.5% P1 versus 16.1% P2, p < 0.001) were observed. No differences were found in chronic lung disease (28.8% versus 13.9%, p = 0.056), severe retinopathy of prematurity (7.5% versus 11.8%, p = 0.403), necrotizing enterocolitis (15.5% versus 6.9%, p = 0.071), severe intraventricular hemorrhage (25.4% versus 18.4%, p = 0.264), mortality (17.5% versus 15.2%, p = 0.690) or survival-without-morbidity adjusted OR = 1.10 (95% CI: 0.55-2.22); p = 0.783. In P2, 24.5% patients were discharged with patent ductus arteriosus. The subgroup born between 23 and 26 weeks (n = 82) showed significant differences: lower incidence of chronic lung disease (50% versus 19.6%, p = 0.019) and more survival-without-morbidity (20% versus 45.6%, p = 0.028) were found. Conclusion: A conservative approach in preterm infants with patent ductus arteriosus can avoid medical and surgical treatments, without a significant impact in survival-without-morbidity. However, two-thirds of preterm infants under 26 weeks are still treated.

Resumo Objetivo O tratamento da persistência do canal arterial ainda é controverso. Nosso objetivo foi descrever o impacto de uma abordagem mais conservadora em nossas taxas de tratamento e nos principais desfechos da prematuridade, especialmente em prematuros com < 26 semanas de gestação. Método Revisão de prontuários de lactentes com ≤ 30 semanas e persistência do canal arterial entre 2009-2016 em dois centros. Em 2011, mudamos o manejo da persistência do canal arterial: no primeiro período (2009-2011), os pacientes que não apresentaram sucesso com o tratamento clínico foram submetidos a fechamento cirúrgico; no segundo período (2012-2016), apenas aqueles com comprometimento cardiopulmonar foram submetidos ao fechamento cirúrgico. Comparamos o tratamento clínico, fechamento cirúrgico, mortalidade e sobrevida sem morbidade. Resultados Foram incluídos 188 pacientes (27 ± 2 semanas, 973 ± 272 gramas); 63 em P1 e 125 em P2. Em P2, foram observadas taxas significativamente mais baixas de tratamento clínico (85,7% no P1 versus 56% no P2, p < 0,001) e fechamento cirúrgico (34,5% no P1 versus 16,1% no P2, p < 0,001). Não foram encontradas diferenças em relação à doença pulmonar crônica (28,8% versus 13,9%, p = 0,056), retinopatia grave da prematuridade (7,5% versus 11,8%, p = 0,403), enterocolite necrosante (15,5% versus 6,9%, p = 0,071), hemorragia intraventricular grave (25,4% versus 18,4%, p = 0,264), mortalidade (17,5% versus 15,2%, p = 0,690) ou OR ajustado pela sobrevida sem morbidade = 1,10 (IC95%: 0,55-2,22); p = 0,783. Em P2, 24,5% dos pacientes receberam alta com persistência do canal arterial. O subgrupo nascido entre 23 a 26 semanas (n = 82) apresentou diferenças significativas, foram encontradas menor incidência de doença pulmonar crônica (50% versus 19,6%, p = 0,019) e maior sobrevida sem morbidade (20% versus 45,6%, p = 0,028). Conclusão Uma abordagem conservadora em prematuros com persistência do canal arterial pode evitar tratamentos clínicos e cirúrgicos, sem um impacto significativo na sobrevida sem morbidade. No entanto, dois terços dos prematuros com menos de 26 semanas ainda são tratados.

Clinical outcomes after more conservative management of patent ductus arteriosus in preterm infants.

OBJECTIVE: Management of patent ductus arteriosus is still controversial. This study aimed to describe the impact of a more conservative approach on treatment rates and on main outcomes of prematurity, especially in preterm infants with <26 weeks of gestation. METHOD: Clinical charts review of infants ≤30 weeks with patent ductus arteriosus between 2009 and 2016 at two centers. In 2011, the authors changed patent ductus arteriosus management: in first period (2009-2011), patients who failed medical treatment underwent surgical closure; in second period (2012-2016), only those with cardiopulmonary compromise underwent surgical ligation. Medical treatment, surgical closure, mortality, and survival-without-morbidity were compared. RESULTS: This study included 188 patients (27±2 weeks, 973±272 grams); 63 in P1 and 125 in P2. In P2, significantly lower rates of medical treatment (85.7% P1 versus 56% P2, p<0.001) and surgical closure (34.5% P1 versus 16.1% P2, p<0.001) were observed. No differences were found in chronic lung disease (28.8% versus 13.9%, p=0.056), severe retinopathy of prematurity (7.5% versus 11.8%, p=0.403), necrotizing enterocolitis (15.5% versus 6.9%, p=0.071), severe intraventricular hemorrhage (25.4% versus 18.4%, p=0.264), mortality (17.5% versus 15.2%, p=0.690) or survival-without-morbidity adjusted OR=1.10 (95% CI: 0.55-2.22); p=0.783. In P2, 24.5% patients were discharged with patent ductus arteriosus. The subgroup born between 23 and 26 weeks (n=82) showed significant differences: lower incidence of chronic lung disease (50% versus 19.6%, p=0.019) and more survival-without-morbidity (20% versus 45.6%, p=0.028) were found. CONCLUSION: A conservative approach in preterm infants with patent ductus arteriosus can avoid medical and surgical treatments, without a significant impact in survival-without-morbidity. However, two-thirds of preterm infants under 26 weeks are still treated.

Effects of therapeutic approach on the neonatal evolution of very low birth weight infants with patent ductus arteriosus / Efeitos da abordagem terapêutica da persistência de canal arterial sobre a evolução neonatal de recém-nascidos de extremo baixo peso

OBJECTIVE: To analyze the effects of treatment approach on the outcomes of newborns (birth weight [BW] < 1,000 g) with patent ductus arteriosus (PDA), from the Brazilian Neonatal Research Network (BNRN) on: death, bronchopulmonary dysplasia (BPD), severe intraventricular hemorrhage (IVH III/IV), retinopathy of prematurity requiring surgical (ROPsur), necrotizing enterocolitis requiring surgery (NECsur), and death/BPD. METHODS: This was a multicentric cohort study, retrospective data collection, including newborns (BW < 1000 g) with gestational age (GA) < 33 weeks and echocardiographic diagnosis of PDA, from 16 neonatal units of the BNRN from January 1, 2010 to Dec 31, 2011. Newborns who died or were transferred until the third day of life, and those with presence of congenital malformation or infection were excluded. Groups: G1 - conservative approach (without treatment), G2 - pharmacologic (indomethacin or ibuprofen), G3 - surgical ligation (independent of previous treatment). Factors analyzed: antenatal corticosteroid, cesarean section, BW, GA, 5 min. Apgar score < 4, male gender, Score for Neonatal Acute Physiology Perinatal Extension (SNAPPE II), respiratory distress syndrome (RDS), late sepsis (LS), mechanical ventilation (MV), surfactant (< 2 h of life), and time of MV. Outcomes: death, O2 dependence at 36 weeks (BPD36wks), IVH III/IV, ROPsur, NECsur, and death/BPD36wks. Statistics: Student's t-test, chi-squared test, or Fisher's exact test; Odds ratio (95% CI); logistic binary regression and backward stepwise multiple regression. Software: MedCalc (Medical Calculator) software, version 12.1.4.0. p-values < 0.05 were considered statistically significant. RESULTS: 1,097 newborns were selected and 494 newborns were included: G1 - 187 (37.8%), G2 - 205 (41.5%), and G3 - 102 (20.6%). The highest mortality was observed in G1 (51.3%) and the lowest in G3 (14.7%). The highest frequencies of BPD36wks (70.6%) ...

OBJETIVO: Analisar os efeitos da terapêutica adotada para o canal arterial (CA) em recém-nascidos (RN) < 1.000gadmitidos em unidades neonatais (UN) da Rede Brasileira de Pesquisas Neonatais (RBPN), sobre os desfechos: óbito, displasia broncopulmonar (DBP), hemorragia intraventricular grave (HIVIII/IV), retinopatia da prematuridade cirúrgica (ROPcir), enterocolite necrosante cirúrgica (ECNcir) e o desfecho combinado óbito e DBP. MÉTODOS: Estudo multicêntrico, de coorte, coleta de dados retrospectiva, incluindo RN de 16 UN da RBPN de 01/01/2010 a 31/12/2011, PN < 1.000 g, idade gestacional (IG) < 33 semanas e diagnóstico ecocardiográfico de PCA. Excluídos: óbitos ou transferências até o terceiro dia de vida, infecções congênitas ou malformações. Grupos:G1 - conservadora (sem intervenção medicamentosa ou cirúrgica), G2 - farmacológica (indometacina ou ibuprofeno) e G3 - cirúrgico (com ou sem tratamento farmacológico anterior). Analisou-se: uso de esteroide antenatal, parto cesárea, PN, IG, Apgar5' < 4, sexo masculino, SNAPPE II, síndrome do dDesconforto respiratório (SDR), sepse tardia, ventilação mecânica (VM), surfactante < 2 horas de vida, tempo de VM e os desfechos: óbito, dependência de oxigênio com 36 semanas (DBP36s), HIV III/IV, ROPcir, ECNcir e óbito/DBP36s. Estatística: Teste t-Student, Qui-Quadrado ou teste Exato de Fisher. Testes de Regressão Binária Logística e Regressão Múltipla Stepwise Backward. MedCalc (Medical Calculator) software, versão 12.1.4.0.p < 0,05. RESULTADOS: Foram selecionados 1.097 RN e 494 foram incluídos: G1-187 (37,8%), G2-205 (41,5%) e G3-102 (20,6%). Verificou-se: maior mortalidade (51,3%) no G1 e menor no G3(14,7%); maior frequência DBP36s (70,6%) e ROPcir (23,5%) ...

Effects of therapeutic approach on the neonatal evolution of very low birth weight infants with patent ductus arteriosus.

OBJECTIVE: To analyze the effects of treatment approach on the outcomes of newborns (birth weight [BW] < 1,000 g) with patent ductus arteriosus (PDA), from the Brazilian Neonatal Research Network (BNRN) on: death, bronchopulmonary dysplasia (BPD), severe intraventricular hemorrhage (IVH III/IV), retinopathy of prematurity requiring surgical (ROPsur), necrotizing enterocolitis requiring surgery (NECsur), and death/BPD. METHODS: This was a multicentric, cohort study, retrospective data collection, including newborns (BW < 1000 g) with gestational age (GA) < 33 weeks and echocardiographic diagnosis of PDA, from 16 neonatal units of the BNRN from January 1, 2010 to Dec 31, 2011. Newborns who died or were transferred until the third day of life, and those with presence of congenital malformation or infection were excluded. Groups: G1 - conservative approach (without treatment), G2 - pharmacologic (indomethacin or ibuprofen), G3 - surgical ligation (independent of previous treatment). Factors analyzed: antenatal corticosteroid, cesarean section, BW, GA, 5 min. Apgar score < 4, male gender, Score for Neonatal Acute Physiology Perinatal Extension (SNAPPE II), respiratory distress syndrome (RDS), late sepsis (LS), mechanical ventilation (MV), surfactant (< 2 h of life), and time of MV. OUTCOMES: death, O2 dependence at 36 weeks (BPD36wks), IVH III/IV, ROPsur, NECsur, and death/BPD36wks. STATISTICS: Student's t-test, chi-squared test, or Fisher's exact test; Odds ratio (95% CI); logistic binary regression and backward stepwise multiple regression. Software: MedCalc (Medical Calculator) software, version 12.1.4.0. p-values < 0.05 were considered statistically significant. RESULTS: 1,097 newborns were selected and 494 newborns were included: G1 - 187 (37.8%), G2 - 205 (41.5%), and G3 - 102 (20.6%). The highest mortality was observed in G1 (51.3%) and the lowest in G3 (14.7%). The highest frequencies of BPD36wks (70.6%) and ROPsur were observed in G3 (23.5%). The lowest occurrence of death/BPD36wks occurred in G2 (58.0%). Pharmacological (OR 0.29; 95% CI: 0.14-0.62) and conservative (OR 0.34; 95% CI: 0.14-0.79) treatments were protective for the outcome death/BPD36wks. CONCLUSION: The conservative approach of PDA was associated to high mortality, the surgical approach to the occurrence of BPD36wks and ROPsur, and the pharmacological treatment was protective for the outcome death/BPD36wks.