Study background and rationale
Respiratory Distress Syndrome (RDS) is a common cause of morbidity and
mortality in preterm neonates, especially those <34 weeks of
gestation. Though the cases of classical severe Hyaline Membrane Disease
(HMD) are seen very less recently with the increasing usage of Antenatal
Corticosteroid, a sizable number of preterm neonates do require
Surfactant Replacement Therapy despite receiving best of the Delivery
room practices including Continuous Positive Airway Pressure (CPAP).
Animal-derived Natural
Surfactant preparations are the ones now recommended as standard of care
practice for Surfactant replacement therapy in RDS1.
Among these, bovine origin surfactant or Beractant (Survanta), Bovine
Lung Extract Surfactant – BLES (Neosurf) and Porcine origin surfactant
– Poractant α (Curosurf) are available for commercial use in India.
There have been a few comparative studies evaluating natural
surfactants. Results differ based on comprehensive newborn unit policies
used for overall management of RDS. An important study among these,
Ramanathan et al. compared the efficacy and safety of poractant alfa and
beractant in preterm infants with RDS (3 groups: 100 mg/kg of poractant
alfa, 200 mg/kg of poractant alfa, and 100 mg/kg of beractant).
Mortality, redosing of surfactant, and oxygen supplements were
significantly reduced in the 200 mg/kg of poractant alfa group than in
the 100 mg/kg of poractant alfa or beractant groups2.
However, it has also been reported that the timing of administration of
the surfactant, such as prophylactic versus rescue and early (within 2
hours after birth) versus delayed (later than 2 hours after birth)
treatment, is more important than the composition of the
surfactant3. A recent meta-analysis in 2019, showed
that poractant-α (at 200 mg/kg dose) is associated with better short
term respiratory outcomes including lesser combined outcome of
BPD/mortality when compared to bovine surfactants at their licensed dose
(100 mg/kg) in preterm neonates with RDS4. The pooled
analysis also showed an unusually high rate of redosing with bovine
surfactant (45% vs 21%) compared to porcine, which is hardly seen in
clinical practice. Most of these studies are a decade older, where the
practice of antenatal steroids, delivery room CPAP, timing of
surfactant, surfactant need (rescue/prophylactic) etc. were still
evolving. Higher doses of Poractant- α will also incur higher cost. In
contrast to meta-analysis, systematic review of studies of real-world
evidence shows similar outcomes in both types of animal derived
surfactant.5 Also, there is limited evidence from the
Indian subcontinent comparing the animal-derived natural surfactants in
their standard prescribed doses in real world scenarios. Hence, the
current study was planned to evaluate the effect of surfactant
preparations in preterm RDS on various morbidities.