I read the article by Singh, et al.
with great interest [1]. However, I would like to point out
few issues which need clarification.
First, out of 296 infants of respiratory
distress syndrome (RDS) requiring continuous positive airway
pressure (CPAP), a total of 150 infants required intubation
for invasive ventilation and another 53 infants requiring
intubation couldn’t be randomized due to non-availability of
designated ventilator. This means that there was a CPAP
failure in 69% of the cases. Studies from India itself had
shown a much lower CPAP failure rate of around 25 to 40%
despite the use of surfactant in selected cases [2, 3]. This
high failure rate of CPAP raises its own set of issues: how
accurately was the definition of respiratory distress
syndrome (RDS) being applied? What is the policy for
surfactant administration in the unit? Are these findings
generalizable to settings where the rate of CPAP failure is
almost half?
Second, the authors have excluded the
infants which were off ventilation within 24 hours after
randomization. This is despite of the fact that oxygenation
index at 1 and 6 hours of ventilation was also the part of
primary outcome. These infants constituted more than one
fourth of the total participants in the trial and their
exclusion could have resulted in biased results. What is the
reason of their exclusion and how were they adjusted in the
final analysis needs clarification?
Third, the information regarding the
distribution of various brands of surfactant used, their
doses and the total number of times the surfactant was
administered in both the groups is lacking. All these
factors affect the FiO
1. Singh SN, Malik GK, Prashanth GP,
Singh A, Kumar M. High frequency oscillatory ventilation
versus synchronized intermittent mandatory ventilation
in preterm neonates with hyaline membrane disease: A
randomized controlled trial. Indian Pediatr. 2012;49:405-8.
2. Koti J, Murki S, Gaddam P, Reddy A,
Reddy MD. Bubble CPAP for respiratory distress syndrome in
preterm infants. Indian Pediatr. 2010;47:139-43.
3. Saxena A, Thapar RK, Sondhi V, Chandra
P. Continuous positive airway pressure for spontaneously
breathing premature infants with respiratory distress
syndrome. Indian J Pediatr. 2012 Mar 7. [Epub ahead of
print]
4. Speer CP, Gefeller O, Groneck P,
Laufkötter E, Roll C, Hanssler L, et al. Randomised
clinical trial of two treatment regimens of natural
surfactant preparations in neonatal respiratory distress
syndrome. Arch Dis Child Fetal Neonatal Ed. 1995;72:F8-13.
5. Ramanathan R, Rasmussen MR, Gerstmann DR, Finer N,
Sekar K. North American Study Group. A randomized,
multicenter masked comparison trial of poractant alfa (Curosurf)
versus beractant (Survanta) in the treatment of
respiratory distress syndrome in preterm infants. Am J
Perinatol. 2004;21:109-19.