Trial reportPloS one2017
Poractant alfa versus bovine lipid extract surfactant for infants 24+0 to 31+6 weeks gestational age: A randomized controlled trial.
Trial report in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01709409 (A Randomized, Controlled, Partially Double-blinded, Phase 3, Multi-center Trial to Determine if Curosurf® Reduces the Duration of Mechanical Ventilation in Infants 24+0 to 31+6 Weeks Gestational Age), which is not on this map. Cited by 14 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Controlled, Partially Double-blinded, Phase 3, Multi-center Trial to Determine if Curosurf® Reduces the Duration of Mechanical Ventilation in Infants 24+0 to 31+6 Weeks Gestational Age
Who cites it
14 citing papers in PubMed, 3 syntheses or guidelines pooled it, 19 citations in OpenAlex.
- Eligibility Criteria and Representativeness of Randomized Clinical Trials That Include Infants Born Extremely Premature: A Systematic Review.The Journal of pediatrics · 2021Pooled it
- Porcine versus bovine surfactant therapy for RDS in preterm neonates: pragmatic meta-analysis and review of physiopathological plausibility of the effects on extra-pulmonary outcomes.Respiratory research · 2020Pooled it
- Porcine vs bovine surfactant therapy for preterm neonates with RDS: systematic review with biological plausibility and pragmatic meta-analysis of respiratory outcomes.Respiratory research · 2019Pooled it
- Commentary on: Comparison of Bovine Lipid Extract Surfactant and Poractant Alfa Administered via LISA in Preterm Infants (28 + 0 to 34 + 6 Week) With Respiratory Distress Syndrome: A Randomized Controlled Trial.Pediatric pulmonology · 2025Article
- Research progress on pathophysiologic mechanisms, clinical treatment and predictive biomarkers in bronchopulmonary dysplasia: from the perspective of oxidative stress.Frontiers in pediatrics · 2024Review
- Comparing the clinical and economic efficiency of four natural surfactants in treating infants with respiratory distress syndrome.PloS one · 2023Article
- Poractant alfa versus bovine lipid extract surfactant: prospective comparative effectiveness study.Journal of perinatology : official journal of the California Perinatal Association · 2022Article
- Guidelines for surfactant replacement therapy in neonates.Paediatrics & child health · 2021Review
- Characteristics and outcomes of preterm neonates according to number of doses of surfactant received.Journal of perinatology : official journal of the California Perinatal Association · 2021Article
- "Optimal surfactant delivery protocol using the bovine lipid extract surfactant: a quality improvement study".Journal of perinatology : official journal of the California Perinatal Association · 2021Article
- A call for a streamlined ethics review process for multijurisdictional, child health research studies.Paediatrics & child health · 2020Article
- High-volume surfactant administration using a minimally invasive technique: Experience from a Canadian Neonatal Intensive Care Unit.Paediatrics & child health · 2019Article
- Effective in vivo treatment of acute lung injury with helical, amphipathic peptoid mimics of pulmonary surfactant proteins.Scientific reports · 2018Article
- Effects of bovine lipid extract surfactant administration in preterm infants treated for respiratory distress syndrome.Health science reports · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo compare the efficacy and safety of poractant alfa and bovine lipid extract surfactant in preterm infants. STUDY
designRandomized, partially-blinded, multicenter trial. Infants <32 weeks needing surfactant before 48 hours were randomly assigned to receive poractant alfa or bovine lipid extract surfactant. The primary outcome was being alive and extubated at 48 hours post-randomization. Secondary outcomes included need for re-dosing, duration of respiratory support and oxygen, bronchopulmonary dysplasia, mortality and complications during administration.
resultsThree centers recruited 87 infants (mean 26.7 weeks and 906 grams) at a mean age of 5.9 hours, between March 2013 and December 2015. 21/42 (50%) were alive and extubated at 48 hours in the poractant alfa group vs 26/45 (57.8%) in the bovine lipid extract surfactant group; adjusted OR 0.76 (95% CI 0.30-1.93) (p = 0.56). No differences were observed in the need to re-dose. Duration of oxygen support (41.5 vs 62 days; adjusted OR 1.69 95% CI 1.02-2.80; p = 0.04) was reduced in infants who received poractant alfa. We observed a trend in bronchopulmonary dysplasia among survivors (51.5% vs 72.1%; adjusted OR 0.35 95%CI 0.12-1.04; p = 0.06) favoring poractant alfa. Twelve infants died before discharge, 9 in the poractant alfa group and 3 in the bovine lung extract group. Severe airway obstruction following administration was observed in 0 (poractant alfa) and 5 (bovine lipid extract surfactant) infants (adjusted OR 0.09 95%CI <0.01-1.27; p = 0.07).
conclusionNo statistically significant difference was observed in the proportion of infants alive and extubated within 48h between the two study groups. Poractant alfa may be more beneficial and associated with fewer complications than bovine lipid extract surfactant. However, we observed a trend towards higher mortality in the poractant alfa group. Larger studies are needed to determine whether observed possible benefits translate in shorter hospital admissions, or other long term benefits and determine whether there is a difference in mortality.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.