Methods |
Randomized controlled trial |
Participants |
Inborn infants less than 32 weeks gestation with respiratory distress syndrome (RDS) were randomly assigned to receive either colfosceril palmitate (Exosurf Neonatal) an artificial surfactant, or beractant (Survanta) an animal derived surfactant |
Interventions |
Colfosceril palmitate (Exosurf Neonatal) or beractant (Survanta) |
Outcomes |
Endotracheal or hypopharyngeal aspirates were obtained from these infants and from control infants who had normal lungs. The aspirates were taken prior to and up to 28 days following surfactant administration. Phospholipids were separated by thin layer chromatography and expressed as a per cent of total phospholipid measured. Infants with normal lungs had a higher proportion of phosphatidylcholine than those with RDS prior to treatment. The infants with normal lungs had a greater proportion of phosphatidylinositol in their lung aspirates than both treatment groups at 24 h. Infants in the beractant (Survanta) group had a higher proportion of phosphatidylglycerol at 48 h than the group with normal lungs. No other differences were found in phospholipid composition up to 28 days. There were no major differences in the phospholipid profile in infants with RDS treated with either colfosceril palmitate (Exosurf Neonatal) or beractant (Survanta). Neither the clinical differences initially seen between infants treated with either colfosceril palmitate (Exosurf Neonatal) or beractant (Survanta) nor the long‐term outcome could be explained by the phospholipid composition of serial samples of lung aspirates |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment (selection bias) |
Low risk |
Blinding of randomization: yes |
Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Blinding of intervention: unclear |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Blinding of outcome measurement: unclear |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Complete follow‐up: yes |
Selective reporting (reporting bias) |
High risk |
Many clinically important outcome measures not reported |