Phibbs 1991.
Methods | Randomized Single Center Blinding of randomization: Yes (sealed envelopes) Blinding of intervention: No Complete Follow‐up: Short term: Yes Long term: none Blinding of outcome measurement: No Stratification: Based on birthweight | |
Participants | Neonates Birthweight >650 grams Clinical diagnosis of hyaline membrane disease Ventilatory support for infants 650‐1250 grams: (mean airway pressure equal to or >7 cm H20) FiO2 equal to or > 0.4 for infants >1250 grams: mean airway pressure equal to or >8 cm H2; FiO2 equal to or >0.5 Arterial catheter No major congenital anomaly No meconium aspiration Granulocyte count equal to or >1000/mm3 Age 4‐24 hours Infants randomized: Exosurf = 57 Air placebo = 53 | |
Interventions | Intratracheal Exosurf Neonatal (5ml/kg) given in 4 aliquots or sham treatment (air) | |
Outcomes | Incidence of major complications: chronic lung disease patent ductus arteriosus intracranial hemorrhage mortality ventilatory requirements | |
Notes | 110 infants randomized 6 excluded from analysis (4 treated, 2 control) |