Phibbs 1991.
Methods | Randomized Single center Blinding of randomization: yes (sealed envelopes) Stratification based on gestational age and gender Blinding of intervention: no Complete follow‐up: yes Blinding of outcome measures: no | |
Participants | Premature infants Gestational age <34 weeks Birthweight 700‐1350 grams No major congenital anomaly Infants randomized: Exosurf = 38 Air Placebo = 39 | |
Interventions | Intratracheal Exosurf Neonatal (5 ml/kg) or sham treatment (air) in delivery room after intubation and minimal ventilation | |
Outcomes | PRIMARY OUTCOME:
Respiratory Distress Syndrome
Ventiltory requirements SECONDARY OUTCOMES: Complications of prematurity Neonatal and Respiratory Mortality |
|
Notes | Infants with congenital malformations excluded from all analyses (2 treatment, 1 control) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Stratification based on gestational age and gender |
Allocation concealment? | Low risk | Blinding of randomization: yes (sealed envelopes) |
Blinding? All outcomes | High risk | Blinding of intervention: no Blinding of outcome measures: no |
Incomplete outcome data addressed? All outcomes | Low risk | Complete follow‐up: yes |
Free of selective reporting? | Low risk | |
Free of other bias? | Low risk |