Table 1

 Summary of data from randomised controlled trials

AuthorSurfactantEntry criteriaExclusionsPrimary outcomeSample size calculationNumber of centresControl groupBlindedTechnique of randomisation
Dunn10 Calf (now  called  BLES)< 30 weeksMalformations, rupture  of membranes > 2  weeks and  oligohydramniosDifference in arterial,  alveolar oxygen ratio  of 0.1 (0.15)60 per group at 90%  power at α =0.051YesNoEnvelopes sequentially  numbered. Randomisation not  stated. Stratified 24-26 weeks  and 27-29 weeks
Kendig11 Calf (now  called  Infasurf)< 30 weeksMalformations15% difference in  survival450 total at 80% power  and α =0.05 3NoNoEnvelopes consecutively  numbered for each centre.  Randomised blocks of 8
Egberts12 Curosurf26-30  weeksMalformations, ROM >  3 weeks40% increase in  transcutaneous  oxygen to FiO2 ratio,  50% reduction in x
 ray of RDS
50 per group for 1st  outcome and 57 per  group for second  outcome at 80% power  and α =0.054NoNoEnvelopes in each centre in  blocks of 4 or 8
Kattwinkel 13 Infasurf29-32  weeksMalformations, positive  blood culture at birth.  Judged too mature,  severe perinatal  asphyxia7% difference in  moderate RDS ( mean  airway pressure => 8  cm H2O or FiO2  =>0.4)1320 total at 90% power  and α =0.058NoNoEnvelopes. Randomisation not  stated
Walti14 Curosurf25-31  weeksMalformations, stillborn,  ROM > 3 weeks20% difference in  survival without BPD  at 28 days250 total at 90% power  and α =0.0512NoNoEnvelopes Randomisation not  stated
Bevilacqua 15 Curosurf24-30  weeksMalformations or  infectionTo reduce by 30% the  incidence of grade 3-4  RDS280 total at 80% power  and α 5%18NoNoEnvelopes stratified for gestation