PICO Summary: Do protein containing synthetic surfactant preparations improve pulmonary outcomes more than animal derived surfactant preparations in preterm infants with the need for mechanical ventilation for RDS?

BackgroundRespiratory distress syndrome (RDS) causes significant mortality and morbidity in preterm infants. The introduction of surfactant was an important improvement in neonatal care (Jobe, 1993). Several animal as well as synthetic derived surfactant preparations have been developed and tested. Studies show that administration of animal derived surfactant preparations lead to better pulmonary outcomes and lower mortality compared to non-protein containing synthetic derived surfactant preparations (Soll and Blanco, 2001). Recently developed surfactant preparations with peptides added in an aqueous dispersion of phospholipids are believed to mimic endogenous pulmonary protein functions. Protein (or peptide) containing synthetic surfactants may have an increased resistance to inactivation, less infectious risk, less risk of inflammation and immunogenicity, and less batch-to-batch variability.
ParticipantsInfants < 37 weeks' gestation or low birth weight infants (<2500 g) at risk for or having RDS (i.e. oxygen requirement, respiratory distress and consistent chest radiograph).
InterventionSynthetic derived protein (or peptide) containing surfactant preparations.
ComparisonAnimal derived surfactant preparations.
Outcome(s)• Incidence of mortality < 28 days of age, at 36 weeks postmenstrual age and prior to hospital discharge.
 • Incidence of bronchopulmonary dysplasia (BPD) defined as need for oxygen at 28 days of age and/or 36 weeks postmenstrual age.
 • Need for mechanical ventilation, i.e. ventilation continuing for 1 h or more after surfactant administration in the early treatment group or initiated for respiratory insufficiency or apnea in either group.
StudiesRandomized or quasi-randomized controlled trials.
Study description and settingTwo multicenter randomized controlled clinical trials met selection criteria and were included in this review.
ResultsBoth studies compared prophylactic administered protein containing synthetic surfactant (lucinactant) to animal derived surfactants (beractant or poractant alfa). Meta-analyses of these two trials randomizing 1037 infants showed no significant differences in the three outcomes, although a trend towards decreased risk of mortality both at 28 days and at 36 weeks postmenstrual age is noted in the group that received protein containing synthetic surfactant (typical RR 0.79, 95% CI 0.61, 1.02; typical RR 0.81, 95% CI 0.64, 1.03, respectively).
Confidence in resultsHigh quality evidence for all primary outcomes reported.
Key figure(s)Thumbnail image of
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Figure captionMortality at 28 days postnatal age (above) and 36 weeks postmenstrual age (below)
Search for eligible studiesCENTRAL, MEDLINE, EMBASE, CINAHL, abstracts from scientific meetings published in Pediatric Research and reference lists of identified trials and reviews were searched through August 2007.
ConclusionProtein containing synthetic surfactant preparations represent a promising but as yet unproven therapy for the prevention or treatment of RDS.
CitationPfister RH, Soll R, Wiswell TE. Protein containing synthetic surfactant versus animal derived surfactant extract for the prevention and treatment of respiratory distress syndrome. Cochrane Database of Systematic Reviews 2007, Issue 4. Art. No.: CD006069. DOI: 10.1002/14651858.CD006069.pub3.
Date completed5 February 2010
People who helped prepare this Cochrane PICO:Wes Onland (w.onland@amc.uva.nl), Fellow Neonatology, Emma Children's Hospital AMC, Amsterdam, The Netherlands.