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. 1998 Jul 27;1998(3):CD001149. doi: 10.1002/14651858.CD001149

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)