Results
Out of 1149 infants, between 24-34 weeks of gestation, 302 (26%) babies received surfactant after stabilisation with CPAP (rescue surfactant). 158 babies received porcine and 144 received bovine surfactant via INSURE technique. The mean gestation (standard deviation) of the enrolled babies were 29 (2) weeks. The mean birth weight (standard deviation) of the babies was 1270 grams (437). The demographic characteristics are summarised in table 1. At baseline, the porcine group had babies with lower gestation and birth weight and higher proportion of babies with completion of antenatal steroid course, lower APGARs, CLD, screen positive early onset sepsis, PDA requiring treatment; and longer length of stay compared to babies receiving any bovine surfactant. The combined outcome of death or CLD was statistically significant in porcine compared to the bovine group [48 (30%) vs 20 (13%), OR:2.7; 95% CI:1.5-4.8; p=0.001]. Redosing [27 (17%) Vs 18 (12%), OR:1.4; 95% CI:0.7-2.7; p=0.2] was similar in both the groups. Other important morbidities like duration of CPAP, invasive ventilation, air leak, severe IVH, ROP requiring LASER, NEC were similar.
Subgroup analysis of babies >28 weeks showed a similar rate of combined outcome of CLD/death [16 (14%) Vs 14 (10%), OR1.4; 95% CI:0.6-3; p=0.4. There was a higher proportion of screen positive early onset sepsis and longer length of stay. Other morbidities like redosing, air leak, need for invasive ventilation and CPAP duration were similar between both the groups. The subgroup analysis is summarised in table 2.
On comparison of three different surfactant preparations, the CLD or combined outcome with CLD and mortality was higher in the porcine group compared to the other two bovine preparations. However, the porcine group had lower gestational age and weight. Other morbidities like redosing, air leak, need for invasive ventilation and CPAP duration was similar. The comparison is summarised in table 3.