Comparison of Efficacy and Pharmacoeconomic Outcomes Between Calfactant and Poractant Alfa in Preterm Infants With Respiratory Distress Syndrome.

OBJECTIVES: In order to evaluate the impact of the surfactant of choice selection, primary end points were to compare the average number of doses per patient, need for mechanical ventilation on day 3, hospital length of stay, and in-hospital mortality between calfactant and poractant alfa in preterm infants with respiratory distress syndrome (RDS). Secondary outcomes included administration complications, development of bronchopulmonary dysplasia (BPD), and estimated average per patient cost among the study population. METHODS: A retrospective chart review was performed at a level IV neonatal intensive care unit between January 2020 and December 2021 to compare the efficacy, safety, and pharmacoeconomic outcomes -following a surfactant of choice switch from calfactant to poractant alfa in preterm infants with RDS. RESULTS: Final analysis included 253 premature infants with gestational age (GA) between 22 and 36 weeks who met inclusion criteria. A total of 118 patients who received calfactant required higher average number of doses, 1.5 vs 1.3 doses (p = 0.031), and had more administration complications than 135 patients who received poractant alfa (10.2 vs 2.2%, p = 0.008). The need for redosing, mechanical ventilation on day 3, hospital length of stay, in-hospital mortality, and development of BPD were comparable between both groups. However, the estimated average per patient cost for poractant alfa was 32% higher than calfactant ($1,901 vs $1,439, p <0.001). CONCLUSIONS: Despite the pharmacoeconomic disadvantage, preterm infants who received poractant alfa needed fewer doses and were less likely to have administration complications compared with those who received calfactant.

Implementation of less-invasive surfactant administration in a Canadian neonatal intensive care unit.

BACKGROUND: Less-invasive surfactant administration (LISA) is a recent technique used extensively in Europe but rarely used in North America. The aim of this study was to describe our experience following LISA implementation using poractant in a Canadian neonatal intensive care (NICU). METHODS: A retrospective analysis was conducted from June 2017 to April 2021 of LISA procedures in preterm infants. Data were collected on patient characteristics, outcomes following LISA, laryngoscopy, and adverse events. The primary outcome was the rate of successful LISA procedures. SETTING: Level IIIa academic NICU. RESULTS: LISA was successful in 93 of 101 infants (92%). Median gestational age was 30.9 weeks (interquartile range [IQR]: 29.4-33.0). All infants received atropine and fentanyl premedication. Eight LISA procedures were unsuccessful: five because of thoracic rigidity and three because of inability to expose the vocal cords. In the 93 successful procedures, a second dose of surfactant was needed for 15 of 93 infants (16.1%), either by repeated LISA (7/15; 7.5%) or by endotracheal intubation (8/15; 8.6%). In 63.4% of successful procedures, one laryngoscopy attempt was made. The median duration of laryngoscopy attempts was 60 s (IQR: 52-110). Two types of catheters were used: the multi-access catheter (MAC) or the Angiocath in 67% and 33% of procedures, respectively. One infant had bradycardia and 30.6% had profound desaturation of <75%. CONCLUSION: LISA with poractant alfa was implemented in a Canadian NICU with a high degree of procedural success. Fentanyl may lead to more adverse events with a risk of interrupting LISA and may not be the ideal agent for this procedure. These results may encourage wider dissemination of LISA in North America.

Preclinical Assessment of Nebulized Surfactant Delivered through Neonatal High Flow Nasal Cannula Respiratory Support.

High-flow nasal cannula (HFNC) is a non-invasive respiratory support (NRS) modality to treat premature infants with respiratory distress syndrome (RDS). The delivery of nebulized surfactant during NRS would represent a truly non-invasive method of surfactant administration and could reduce NRS failure rates. However, the delivery efficiency of nebulized surfactant during HFNC has not been evaluated in vitro or in animal models of respiratory distress. We, therefore, performed first a benchmark study to compare the surfactant lung dose delivered by commercially available neonatal nasal cannulas (NCs) and HFNC circuits commonly used in neonatal intensive care units. Then, the pulmonary effect of nebulized surfactant delivered via HFNC was investigated in spontaneously breathing rabbits with induced respiratory distress. The benchmark study revealed the surfactant lung dose to be relatively low for both types of NCs tested (Westmed NCs 0.5 ± 0.45%; Fisher & Paykel NCs 1.8 ± 1.9% of a nominal dose of 200 mg/kg of Poractant alfa). The modest lung doses achieved in the benchmark study are compatible with the lack of the effect of nebulized surfactant in vivo (400 mg/kg), where arterial oxygenation and lung mechanics did not improve and were significantly worse than the intratracheal instillation of surfactant. The results from the present study indicate a relatively low lung surfactant dose and negligible effect on pulmonary function in terms of arterial oxygenation and lung mechanics. This negligible effect can, for the greater part, be explained by the high impaction of aerosol particles in the ventilation circuit and upper airways due to the high air flows used during HFNC.

A Randomized, Controlled Trial to Investigate the Efficacy of Nebulized Poractant Alfa in Premature Babies with Respiratory Distress Syndrome.

OBJECTIVE: To investigate the efficacy and safety of nebulized poractant alfa (at 200 and 400 mg/kg doses) delivered in combination with nasal continuous positive airway pressure compared with nasal continuous positive airway pressure alone in premature infants with diagnosed respiratory distress syndrome. STUDY DESIGN: This randomized, controlled, multinational study was conducted in infants at 280/7 to 326/7 weeks of gestation. The primary outcome was the incidence of respiratory failure in the first 72 hours of life, defined as needing endotracheal surfactant and/or mechanical ventilation owing to prespecified criteria. Secondary outcomes included the time to respiratory failure in the first 72 hours, duration of ventilation, mortality, incidence of bronchopulmonary dysplasia, and major associated neonatal comorbidities. In addition, the safety and tolerability of the treatments were assessed reporting the number and percentage of infants with treatment-emergent adverse events and adverse drug reactions during nebulization. RESULTS: In total, 129 infants were randomized. No significant differences were observed for the primary outcome: 24 (57%), 20 (49%), and 25 (58%) infants received endotracheal surfactant and/or mechanical ventilation within 72 hours in the poractant alfa 200 mg/kg, poractant alfa 400 mg/kg, and nasal continuous positive airway pressure groups, respectively. Similarly, secondary respiratory outcomes did not differ among groups. Enrollment was halted early owing to a change in the benefit-risk balance of the intervention. Nebulized poractant alfa was well-tolerated and safe, and no serious adverse events were related to the study treatment. CONCLUSIONS: The intervention did not decrease the likelihood of respiratory failure within the first 72 hours of life. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03235986.

Surfactant-Assisted Distal Pulmonary Distribution of Budesonide Revealed by Mass Spectrometry Imaging.

Direct lung administration of budesonide in combination with surfactant reduces the incidence of bronchopulmonary dysplasia. Although the therapy is currently undergoing clinical development, the lung distribution of budesonide throughout the premature neonatal lung has not yet been investigated. Here, we applied mass spectrometry imaging (MSI) to investigate the surfactant-assisted distal lung distribution of budesonide. Unlabeled budesonide was either delivered using saline as a vehicle (n = 5) or in combination with a standard dose of the porcine surfactant Poractant alfa (n = 5). These lambs were ventilated for one minute, and then the lungs were extracted for MSI analysis. Another group of lambs (n = 5) received the combination of budesonide and Poractant alfa, followed by two hours of mechanical ventilation. MSI enabled the label-free detection and visualization of both budesonide and the essential constituent of Poractant alfa, the porcine surfactant protein C (SP-C). 2D ion intensity images revealed a non-uniform distribution of budesonide with saline, which appeared clustered in clumps. In contrast, the combination therapy showed a more homogeneous distribution of budesonide throughout the sample, with more budesonide distributed towards the lung periphery. We found similar distribution patterns for the SP-C and budesonide in consecutive lung tissue sections, indicating that budesonide was transported across the lungs associated with the exogenous surfactant. After two hours of mechanical ventilation, the budesonide intensity signal in the 2D ion intensity maps dropped dramatically, suggesting a rapid lung clearance and highlighting the relevance of achieving a uniform surfactant-assisted lung distribution of budesonide early after delivery to maximize the anti-inflammatory and maturational effects throughout the lung.

Dose Effect of Poractant Alfa in Neonatal RDS: Analysis of Combined Data from Three Prospective Studies.

Aim: To evaluate the effect of the initial dose of poractant alfa on clinical outcomes in neonatal respiratory distress syndrome (RDS) and to assess adherence to treatment guidelines recommending a dose of 200 mg/kg. Methods: Records of neonates who received poractant alfa with a less invasive technique (LISA) or with the INtubate-SURfactant-Extubate (INSURE) technique were retrieved from the aggregated datasets of three prospective RDS studies conducted between 2015 and 2019. The impact of poractant dose on neonatal outcomes was analyzed by multivariate logistic regression. The primary endpoint was the need for early (<72 h of life) mechanical ventilation (MV). Typical complications of prematurity and the need for surfactant retreatment were secondary endpoints. Deviation from the 200 mg/kg dose of surfactant was a measure of compliance with the treatment guidelines. As a complementary analysis, the rates of adverse outcomes were compared for infants receiving high (200 mg/kg ±10%) and low (100 mg/kg ±10%) doses of poractant. Results: Of 994 eligible infants, 574 received poractant alfa with LISA, and 420 received poractant with INSURE. A logistic regression model using data from all 994 infants showed that the surfactant dose had a significant effect on reducing the need for MV and retreatment; the respective odds ratios were 0.92 (95% CI: 0.90-0.95) and 0.93 (95% CI: 0.90-0.96) per 10-mg/kg dose increment of poractant alfa. This dose effect was observed across all gestational age ranges and in infants treated with LISA. In newborns treated with INSURE, the dose of surfactant only influenced the rates of retreatment (p = 0.036) but not MV (p = 0.170). No impact on other neonatal outcomes was observed. In the subset of infants who received high (N = 502) and low (N = 58) doses of poractant, the high-dose group had lower rates of MV (34 vs. 48%, p = 0.042) and lower rates of retreatment (11 vs. 21%, p = 0.045). Surfactant underdosage increased with gestational age and ranged from a minimum of -3 mg/kg in <26 weeks to a maximum of -23.5 mg/kg in >32 weeks. Conclusions: The initial dose of poractant alfa significantly impacts the need for invasive ventilation and retreatment. More mature newborns are at a greater risk of underdosing.

Effect of two different early rescue surfactant treatments on mortality in preterm infants with respiratory distress syndrome.

INTRODUCTION: Although current evidence suggests that initial dose of 200 mg/kg poractant alfa reduces mortality in the treatment of respiratory distress syndrome (RDS), these data were obtained in a highly heterogeneous group of patients and neither of them addressed mortality as primary outcome. OBJECTIVE: The aim of this study was to investigate the effects of poractant alfa and beractant on mortality when administered as early rescue surfactant therapy in very preterm infants. METHODS: We retrospectively evaluated preterm infants followed in our unit between May 2017 and November 2018 whose gestational age (GA) was ≤28 weeks and received surfactant within the first 2 hours of life. Morbidities and mortality rates were compared between infants who received initial doses of 200 mg/kg poractant alfa and 100 mg/kg beractant. RESULTS: Data from 200 infants who met the inclusion criteria were analyzed. There were 112 patients in the poractant alfa group and 88 patients in beractant group. Mean gestational age in these groups was 26 ± 2 and 25.8 ± 1.8 weeks (P = 0.45) and mean birth weight was 812 ± 243 and 840 ± 208 g (P = 0.39), respectively. The poractant alfa and beractant groups had similar rates of overall mortality (53.5% vs 56.8%), mortality in first 7 days (30.5% vs 25.8%), and beyond day 7 (16.4% vs 13.3%) (P > 0.05). There were no differences in the incidence of preterm morbidities among the two groups. CONCLUSION: We were unable to demonstrate the superiority of poractant in terms of mortality in very preterm infants with RDS. These findings need to be supported by multicenter, randomized controlled trials.

From bench to bedside: in vitro and in vivo evaluation of a neonate-focused nebulized surfactant delivery strategy.

BACKGROUND: Non-invasive delivery of nebulized surfactant has been a neonatology long-pursued goal. Nevertheless, the clinical efficacy of nebulized surfactant remains inconclusive, in part, due to the great technical challenges of depositing nebulized drugs in the lungs of preterm infants. The aim of this study was to investigate the feasibility of delivering nebulized surfactant (poractant alfa) in vitro and in vivo with an adapted, neonate-tailored aerosol delivery strategy. METHODS: Particle size distribution of undiluted poractant alfa aerosols generated by a customized eFlow-Neos nebulizer system was determined by laser diffraction. The theoretical nebulized surfactant lung dose was estimated in vitro in a clinical setting replica including a neonatal continuous positive airway pressure (CPAP) circuit, a cast of the upper airways of a preterm neonate, and a breath simulator programmed with the tidal breathing pattern of an infant with mild respiratory distress syndrome (RDS). A dose-response study with nebulized surfactant covering the 100-600 mg/kg nominal dose-range was conducted in RDS-modelling, lung-lavaged spontaneously-breathing rabbits managed with nasal CPAP. The effects of nebulized poractant alfa on arterial gas exchange and lung mechanics were assessed. Exogenous alveolar disaturated-phosphatidylcholine (DSPC) in the lungs was measured as a proxy of surfactant deposition efficacy. RESULTS: Laser diffraction studies demonstrated suitable aerosol characteristics for inhalation (mass median diameter, MMD = 3 µm). The mean surfactant lung dose determined in vitro was 13.7% ± 4.0 of the 200 mg/kg nominal dose. Nebulized surfactant delivered to spontaneously-breathing rabbits during nasal CPAP significantly improved arterial oxygenation compared to animals receiving CPAP only. Particularly, the groups of animals treated with 200 mg/kg and 400 mg/kg of nebulized poractant alfa achieved an equivalent pulmonary response in terms of oxygenation and lung mechanics as the group of animals treated with instilled surfactant (200 mg/kg). CONCLUSIONS: The customized eFlow-Neos vibrating-membrane nebulizer system efficiently generated respirable aerosols of undiluted poractant alfa. Nebulized surfactant delivered at doses of 200 mg/kg and 400 mg/kg elicited a pulmonary response equivalent to that observed after treatment with an intratracheal surfactant bolus of 200 mg/kg. This bench-characterized nebulized surfactant delivery strategy is now under evaluation in Phase II clinical trial (EUDRACT No.:2016-004547-36).

Health Economics and Outcomes of Surfactant Treatments for Respiratory Distress Syndrome Among Preterm Infants in US Level III/IV Neonatal Intensive Care Units.

OBJECTIVE: To compare length of stay (LOS), costs, mechanical ventilation (MV), and mortality in preterm infants treated in the Neonatal Intensive Care Unit (NICU) with beractant (BE), calfactant (CA), and poractant alfa (PA) for Respiratory Distress Syndrome (RDS). METHODS: This study evaluated preterm infants born between 2010 and 2013 with RDS diagnosis, gestational age of 25 to 36 weeks, birthweight of ≥500 g, and age of ≤2 days on first surfactant administration. Multivariable regression was used to evaluate all NICU outcomes. RESULTS: Of 13,240 infants meeting the study criteria, 4136 (31.2%) received BE, 2502 (18.9%) received CA, and 6602 (49.9%) received PA. Adjusted analyses estimated similar mean LOS (BE 26.7 days, CA 27.8 days, and PA 26.2 days) and hospital costs (BE: $50,929; CA: $50,785; and PA: $50,212). Compared to PA, BE and CA were associated with greater odds of MV use on day 3 (OR = 1.56 and 1.60, respectively) and day 7 (OR = 1.39 and 1.28, respectively; all p < 0.05). Adjusted NICU mortality was significantly higher only with CA vs PA (OR = 1.51; p = 0.015). CONCLUSION: Adjusted NICU LOS and costs were similar among BE, CA, and PA. Infants receiving PA were less likely to be on MV at 3 and 7 days, and PA treatment was associated with lower odds of NICU mortality when compared to CA.

Surfactant preparations for preterm infants with respiratory distress syndrome: past, present, and future.

Following the first successful trial of surfactant replacement therapy for preterm infants with respiratory distress syndrome (RDS) by Fujiwara in 1980, several animal-derived natural surfactants and synthetic surfactants have been developed. Synthetic surfactants were designed to overcome limitations of natural surfactants such as cost, immune reactions, and infections elicited by animal proteins contained in natural surfactants. However, first-generation synthetic surfactants that are protein-free have failed to prove their superiority over natural surfactants because they lack surfactant protein (SP). Lucinactant, a second-generation synthetic surfactant containing the SP-B analog, was better or at least as effective as the natural surfactant, suggesting that lucinactant could act an alternative to natural surfactants. Lucinactant was approved by the U. S. Food and Drug Administration in March 2012 as the fifth surfactant to treat neonatal RDS. CHF5633, a second-generation synthetic surfactant containing SP-B and SP-C analogs, was effective and safe in a human multicenter cohort study for preterm infants. Many comparative studies of natural surfactants used worldwide have reported different efficacies for different preparations. However, these differences are believed to due to site variations, not actual differences. The more important thing than the composition of the surfactant in improving outcome is the timing and mode of administration of the surfactant. Novel synthetic surfactants containing synthetic phospholipid incorporated with SP-B and SP-C analogs will potentially represent alternatives to natural surfactants in the future, while improvement of treatment modalities with less-invasive or noninvasive methods of surfactant administration will be the most important task to be resolved.

Surfactant preparations for preterm infants with respiratory distress syndrome: past, present, and future / 소아과

Following the first successful trial of surfactant replacement therapy for preterm infants with respiratory distress syndrome (RDS) by Fujiwara in 1980, several animal-derived natural surfactants and synthetic surfactants have been developed. Synthetic surfactants were designed to overcome limitations of natural surfactants such as cost, immune reactions, and infections elicited by animal proteins contained in natural surfactants. However, first-generation synthetic surfactants that are protein-free have failed to prove their superiority over natural surfactants because they lack surfactant protein (SP). Lucinactant, a second-generation synthetic surfactant containing the SP-B analog, was better or at least as effective as the natural surfactant, suggesting that lucinactant could act an alternative to natural surfactants. Lucinactant was approved by the U. S. Food and Drug Administration in March 2012 as the fifth surfactant to treat neonatal RDS. CHF5633, a second-generation synthetic surfactant containing SP-B and SP-C analogs, was effective and safe in a human multicenter cohort study for preterm infants. Many comparative studies of natural surfactants used worldwide have reported different efficacies for different preparations. However, these differences are believed to due to site variations, not actual differences. The more important thing than the composition of the surfactant in improving outcome is the timing and mode of administration of the surfactant. Novel synthetic surfactants containing synthetic phospholipid incorporated with SP-B and SP-C analogs will potentially represent alternatives to natural surfactants in the future, while improvement of treatment modalities with less-invasive or noninvasive methods of surfactant administration will be the most important task to be resolved.

Poractant Alfa Versus Beractant for Neonatal Respiratory Distress Syndrome: A Retrospective Cost Analysis.

OBJECTIVES: The objectives of this study were to determine the average medication cost per patient of poractant alfa and beractant, and to compare the outcomes of treatment with these agents. METHODS: We conducted a retrospective, observational, cohort study of patients who received surfactant, before and after an institutional formulary change from beractant to poractant alfa. The primary outcome was the average medication cost per case. Secondary measures were clinical outcomes, including duration of respiratory support, length of hospital stay, and the occurrence of complications. RESULTS: A total of 114 patients were enrolled; 38 were treated with poractant alfa and 76 patients were treated with beractant. Baseline characteristics were similar between groups. The average medication cost per patient was $1756.44 ± $1030.06 and $1329.78 ± $705.64 for poractant alfa and beractant, respectively (p = 0.011). Patients treated with poractant alfa had a shorter length of stay (45.0 ± 30.5 days) than patients treated with beractant (65.1 ± 37.1 days) (p = 0.010). Rates of pneumothoraces, pulmonary hemorrhage, necrotizing enterocolitis, intraventricular hemorrhage, and mortality did not differ significantly between groups. CONCLUSIONS: We found an unanticipated increase in drug cost with poractant alfa compared to beractant.

Comparison of the Pharmacoeconomics of Calfactant and Poractant Alfa in Surfactant Replacement erapy.

OBJECTIVE: To compare the pharmacy costs of calfactant (Infasurf, ONY, Inc.) and poractant alfa (Curosurf, Chiesi USA, Inc., Cary, NC). METHODS: The University of South Alabama Children's and Women's Hospital switched from calfactant to poractant alfa in 2013 and back to calfactant in 2015. Retrospectively, we used deidentified data from pharmacy records that provided type of surfactant administered, gestational age, birth weight, and number of doses on each patient. We examined differences in the number of doses by gestational ages and the differences in costs by birth weight cohorts because cost per dose is based on weight. RESULTS: There were 762 patients who received calfactant and 432 patients who received poractant alfa. The average number of doses required per patient was 1.6 administrations for calfactant-treated patients and 1.7 administrations for poractant alfa-treated patients, p = 0.03. A higher percentage of calfactant patients needed only 1 dose (53%) than poractant alfa patients (47%). The distribution of the number of doses for calfactant-treated patients was significantly lower than for the poractant alfa-patients, p < 0.001. Gestational age had no consistent effect on the number of doses required for either calfactant or poractant alfa. Per patient cost was higher for poractant alfa than for calfactant in all birth weight cohorts. Average per patient cost was $1160.62 for poractant alfa, 38% higher than the average per patient cost for calfactant ($838.34). Using poractant alfa for 22 months is estimated to have cost $202,732.75 more than it would have cost if the hospital had continued using calfactant. CONCLUSION: Our experience showed a strong pharmacoeconomic advantage for the use of calfactant compared to the use of poractant alfa because of similar average dosing and lower per patient drug costs.

Effect of syndrome and its nursing application of Poractant Alfa Injection in treatment of neonatal respiratory distress / 中国生化药物杂志

Objective To observe and analyze the Poractant Alfa Injection treatment of neonatal respiratory distress syndrome and the effect of nursing. Methods A total of 60 cases of neonatal respiratory distress syndrome were used as the research object, the patients were divided into two groups of test analysis, study group and control group of 30 patients, two groups of children were using Poractant Alfa Injection for treatment, the control group with routine nursing, the study group using humanized nursing, nursing effect comparison. Results After treatment and nursing, blood gas monitoring index in the study group, mechanical ventilation parameters were better than the control group, P<0.05, the difference was statistically significant. At the same time the study group with family satisfaction with care and compared with the control group increased significantly (P<0.05). Conclusion For children with neonatal respiratory distress syndrome during the treatment by Poractant Alfa Injection, The effect of humanistic nursing is more obvious, which can effectively improve the clinical symptoms of children, and the implementation of nursing intervention can also improve the satisfaction of the families of the children and the effect of treatment.

Effect of syndrome and its nursing application of Poractant Alfa Injection in treatment of neonatal respiratory distress / 中国生化药物杂志

Objective To observe and analyze the Poractant Alfa Injection treatment of neonatal respiratory distress syndrome and the effect of nursing. Methods A total of 60 cases of neonatal respiratory distress syndrome were used as the research object, the patients were divided into two groups of test analysis, study group and control group of 30 patients, two groups of children were using Poractant Alfa Injection for treatment, the control group with routine nursing, the study group using humanized nursing, nursing effect comparison. Results After treatment and nursing, blood gas monitoring index in the study group, mechanical ventilation parameters were better than the control group, P<0.05, the difference was statistically significant. At the same time the study group with family satisfaction with care and compared with the control group increased significantly (P<0.05). Conclusion For children with neonatal respiratory distress syndrome during the treatment by Poractant Alfa Injection, The effect of humanistic nursing is more obvious, which can effectively improve the clinical symptoms of children, and the implementation of nursing intervention can also improve the satisfaction of the families of the children and the effect of treatment.

Effects comparison of Poractant Alfa Injection and ambroxol hydrochloride in treating neonatal respiratory distress syndrome :a Meta analysis / 重庆医学

Objective To systematically assess the clinical effect and safety of Poractant Alfa Injection and ambroxol hydro-chloride in treating neonatal respiratory distress syndrome (NRDS) .Methods The home and abroad randomized controlled trials ( RCTs ) on the comparison of clinical effect and safety of Poractant Alfa Injection and ambroxol hydrochloride in treating NRDS were retrieved by computer .The literature quality was evaluated by the modified JADAD scale .Rev Man5 .3 .1 software was used for conducting the meta analysis .Results Twenty-four RCT were included .The meta analysis results showed that compared with ambroxol hydrochloride ,Poractant Alfa Injection for treating NRDS could more significantly increase the PH value (MD= -0 .02 , 95% CI:-0 .03- -0 .01 ,P<0 .01) ,increased the PaO2 value(MD= -2 .92 ,95% CI:-4 .59 - -1 .26 ,P<0 .01) ,decreased the PaCO2 value (MD=0 .95 ,95% CI:0 .12-1 .77 ,P=0 .02) ,reduced the FiO2 value(MD=0 .03 ,95% CI:0 .01-0 .05 ,P<0 .01) ,en-hanced the Pa O2/FiO2 ratio (MD= -7 .62 ,95% CI:-10 .87 - -4 .37 ,P<0 .01) ,reduced the short term complications (RR=1 .67 ,95% CI:1 .31-2 .12 ,P<0 .01) and long-term complications (RR=2 .85 ,95% CI:1 .14-7 .07 ,P=0 .02) ,shortened the hos-pitalization days (RR=3 .03 ,95% CI:0 .94 -5 .11 ,P<0 .01) as well as decreased the mortality rate (RR=1 .96 ,95% CI:1 .15-3 .34 ,P=0 .01) .However ,there were no statistical differences in the durations of continuous positive airway pressure (CPAP) me-chanical ventilation ,oxygen inhalation time ,time of clinical symptom outcome ,incidence rate of NRDS and total effective rate of treatment between the two groups .Conclusion Currently published evidences show that Poractant Alfa Injection is superior to am-broxol hydrochloride in treating NRDS ,however ,due to limited number of included RCD and medium quality ,the conclusion needs large scale and multicenter RCT verification .

Comparison of efficacy and safety of two available natural surfactants in Iran, Curosurf and Survanta in treatment of neonatal respiratory distress syndrome: A randomized clinical trial.

INTRODUCTION: The benefit of surfactant prescription for respiratory distress syndrome (RDS) has been approved. Curosurf and Survanta are two commonly used natural surfactants in Iran. Previous studies did not report priority for one of these two drugs. The present study aimed to compare the effectiveness and safety of Curosurf and Survanta in treatment of RDS. METHODS: In this randomized clinical trial, neonates were born with RDS diagnosis in two governmental and referral hospitals of Tehran (the capital of Iran) in 2014 were randomly selected. Neonates were randomly assigned into two groups receiving 100 mg/kg Curosurf or Survanta as soon as possible after randomization. Complications, mortality and needing the second dose were compared between the two groups. RESULTS: A total 112 patients with the mean gestational age of 32.59 ± 3.39 weeks were evaluated (56 patients in each group). There were no significant differences regarding birth weight, gestational age, delivery method, and parity between the two groups (P > 0.05). The complications were occurred in 18 neonates (32.1%) of Curosurf group and 20 neonates (35.7%) of Survanta group (RR = 0.922, 95% CI = 0.617-1.379). There were no significant differences regarding complications, mortality, and needing nasal CPAP and endotracheal tube between the two groups. In the neonates with gestational age of 29-32 weeks the IVH and NEC incidence were significantly more in Curosurf group compared to Survanta group (27.8% vs 0% and 22.3% vs 0%, P < 0.05). CONCLUSION: There was no significant difference in complications or mortality between those two groups; however Curosurf was associated with less need of ET tube (in >32 birth weeks subgroup) and NCPAP (in 29-32 birth weeks subgroup) (p = 0.008). Further evaluations with longer follow-up duration are needed for comparing these two surfactants.

Effect of Budesonide combined with Poractant Alfa preventing bronchopulmonary dysplasia in preterm infants / 中华实用儿科临床杂志

Objective To evaluate the effect of Budesonide combined with Poractant Alfa(pulmonary surfactants,PS) on preventing the bronchopulmonary dysplasia (BPD) in preterm infants.Methods One hundred and twenty preterm infants 6 hours after birth(gestational ages≤32 weeks and birth weights ≤1500 g)admitted to the Department of Newborn Medicine,the Affiliated Hospital of Southeast Medical University from October 2013 to February 2015 were randomly divided into 4 group(30 cases in each group).Group A was a control group,group B was neonatal respiratory distress syndrome(NRDS) group,group C was NRDS with PS group,and group D was NRDS with PS and Budesonide group.Thirty-two-week preterms without other diseases and without uptaking oxygen within 48 h were assigned as group A.Group B were treated by continuous uptaking oxygen with continuous positive airway pressure(CPAP) (oxygen uptaken lasting more than 48 h and oxygen concentrations more than 40％).Group C were treated with 100 mg/kg PS within 48 h on the basis of group B.Group D were treated with 0.25 mg/kg Budesonide suspension for inhalation on the basis of group C.The pH value,partial pressure of oxygen [pa(O2)],partial pressure of carbon dioxide [pa(CO2)] in the blood gas analysis were all detected in all groups before treatment,1,6,12,24 and 48 hours after using drug,respectively.All groups were also observed for whether to use respirator assisted ventilation,the duration of high oxygen use,the total time of uptaking oxygen,the rate of using PS again,the rate of BPD,the total hospitalization days and the adverse effects.The adverse effects included high blood pressure,high blood sugar,necrotizing enterocolitis and the incidence of nosocomial infection.Results Compared with group B,the pH value at 1 and 6 hours after using drugs,the pa(O2) and pa(CO2) at 1,6 and 12 hours after using drugs were improved obviously in the group C,and the differences were statistically significant (all P＜0.01).Compared with group B,the above indicators were improved more obvious in group D,and the differences were statistically significant (all P＜0.01).Moreover,compared with the group B,the oxygen inhalation duration,the rate of having a respirator assisted ventilation and using PS again,and the incidence of BPD were obviously decreased in other groups,the differences were statistically significant (all P＜0.05).The incidence of BPD in group D was less than that of group C,and the differences were statistically significant (3.33％ vs 10.00％,x2=4.00,P=0.046).The total oxygen time and the rate of adverse effects of each group were similar.The differences were not statistically significant (all P＞0.05).Conclusions Budesonide combined with Poractant Alfa can prevent BPD in preterm infants.Its effect is better than the simple use of Poractant Alfa,and the rate of adverse effects are not increased significantly.

Efficacy of surfactant-TA, calfactant and poractant alfa for preterm infants with respiratory distress syndrome: a retrospective study.

PURPOSE: To compare the efficacy of the new drug calfactant with the commonly used drugs surfactant-TA and poractant alfa. MATERIALS AND METHODS: A total of 332 preterm infants at 24-31 weeks' gestation with respiratory distress syndrome (RDS) were enrolled and allocated to three groups according to the surfactant instilled; Group 1 (n=146, surfactant-TA), Group 2 (n=96, calfactant), and Group 3 (n=90, poractant alfa). The diagnosis of RDS and the decision to replace the pulmonary surfactant were left to the attending physician and based on patient severity determined by chest radiography and blood gas analysis. Data were collected and reviewed retrospectively using patient medical records. RESULTS: Demographic factors including gestational age, birth weight, Apgar score, clinical risk index for babies II score, and maternal status before delivery were not different between the study groups. Instances of surfactant redosing and pulmonary air leaks, as well as duration of mechanical ventilation, were also not different. Rates of patent ductus arteriosus, intraventricular hemorrhage (≥grade III), periventricular leukomalacia, high stage retinopathy of prematurity, necrotizing enterocolitis (≥stage II), and mortality were also similar, as was duration of hospital stay. Cases of pulmonary hemorrhage and moderate to severe bronchopulmonary dysplasia were increased in Group 3. CONCLUSION: Calfactant is equally as effective as surfactant-TA and poractant alfa. This was the first study comparing the efficacy of surfactant-TA, calfactant, and poractant alfa in a large number of preterm infants in Korea. Further randomized prospective studies on these surfactants are needed.

Clinical study of poractant alfa injection therapy for neonatal respiratory distress syndrome / 中国基层医药

Objective To investigate the effect of poractant alfa injection(PS) on neonatal respiratory distress syndrome(NRDS).Methods According to the digital table,80 cases of NRDS were randomly divided into the control group (40 cases) and the treatment group (40 cases).Both two groups were treated by mechanical ventilation and conventional symptomatic,supportive treatment.The treatment group was given PS intratracheal injection,the control group was given 0.9％ sodium chloride injection intratracheal injection.The clinical symptoms,blood gas analysis and the improvement of X-ray chest film were dynamicly observed,the clinical efficacy was compared between the two groups.Results In the treatment group,PaO2 returned to ＞ 60mmHg time,PaCO2 returned to ＜ 50mmHg time,mechanical ventilation time were (2.13 ± 0.21) h,(12.56 ± 0.11) h,(18.2 ± 0.33) h,which were shorter than those in the control group [(12.41 ± 0.13) h,(89.87 ± 0.26) h,(76.13 ± 0.65) h,t =2.632,2.403,1.895,all P ＜ 0.05] ;39 cases in the treatment group were cured(97.5％),30 cases in the control group were cured(75.0％),the difference of cure rate between the two groups was statistically significant(x2 =8.53,P ＜ 0.05).The incidence rate of comnplications such as pulnonary hemorrhage,pneumothorax,intracranial hemorrhage in the treatment group was 7.5％,which was significantly lower than 32.5％ in the control group (x2 =7.81,P ＜ 0.05).Conclusion PS in the treatment of NRDS has obvious curative effect and less adverse reactions,it can be used in clinical application.