Summary of data from randomised controlled trials
| Author | Surfactant | Entry criteria | Exclusions | Primary outcome | Sample size calculation | Number of centres | Control group | Blinded | Technique of randomisation |
|---|---|---|---|---|---|---|---|---|---|
| Dunn10 | Calf (now called BLES) | < 30 weeks | Malformations, rupture of membranes > 2 weeks and oligohydramnios | Difference in arterial, alveolar oxygen ratio of 0.1 (0.15) | 60 per group at 90% power at α =0.05 | 1 | Yes | No | Envelopes sequentially numbered. Randomisation not stated. Stratified 24-26 weeks and 27-29 weeks |
| Kendig11 | Calf (now called Infasurf) | < 30 weeks | Malformations | 15% difference in survival | 450 total at 80% power and α =0.05 | 3 | No | No | Envelopes consecutively numbered for each centre. Randomised blocks of 8 |
| Egberts12 | Curosurf | 26-30 weeks | Malformations, ROM > 3 weeks | 40% 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 =0.05 | 4 | No | No | Envelopes in each centre in blocks of 4 or 8 |
| Kattwinkel 13 | Infasurf | 29-32 weeks | Malformations, positive blood culture at birth. Judged too mature, severe perinatal asphyxia | 7% difference in moderate RDS ( mean airway pressure => 8 cm H2O or FiO2 =>0.4) | 1320 total at 90% power and α =0.05 | 8 | No | No | Envelopes. Randomisation not stated |
| Walti14 | Curosurf | 25-31 weeks | Malformations, stillborn, ROM > 3 weeks | 20% difference in survival without BPD at 28 days | 250 total at 90% power and α =0.05 | 12 | No | No | Envelopes Randomisation not stated |
| Bevilacqua 15 | Curosurf | 24-30 weeks | Malformations or infection | To reduce by 30% the incidence of grade 3-4 RDS | 280 total at 80% power and α 5% | 18 | No | No | Envelopes stratified for gestation |