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.