Novel SIMPAP for Primary Treatment of Respiratory Distress in Premature Neonates— A Randomized Controlled Trial

Abstract

Background

Preterm neonates are often born with respiratory distress requiring continuous distending pressure respiratory support. Nasal continuous positive airway pressure (CPAP) devices favor a good outcome when initiated early. In our country, most preterm babies are born in healthcare setups that are not equipped to offer CPAP support at birth. The failure to initiate the appropriate treatment in the initial hours could have cascading effects on the outcome. A portable, low-flow driven, non-electrical device, simple continuous positive airway pressure (SIMPAP) [Patent no. 201841018247—Indian PTO] was developed and tested in an earlier in vitro study. The present study was done to compare the efficacy and safety of SIMPAP against bubble CPAP when used as primary support in preterm respiratory distress syndrome (RDS).

Methods

This was a randomized controlled non-inferiority trial conducted among 60 neonates between 28 and 37 weeks of gestation admitted with respiratory distress. The intervention group was initiated on SIMPAP support, and the control group on bubble CPAP. The outcome measured was the change in saturation oxygen pressure index (SOPI) over 6 h.

Results

The SOPI in the CPAP group was 1.150 (1.070-1.408), and in the SIMPAP group was 1.080 (1.060-1.501). The difference between the SOPI measured at recruitment and 6 h in the CPAP group was 0.020 (−0.001 to 0.213) and in the SIMPAP group was 0.010 (0.000-0.030), P = 0.847. SOPI at the end of 72 h was 1.07 (1.05-1.07) and 1.05 (1.05) in the control and intervention groups, respectively. The complications between the two groups were not statistically significant.

Conclusion

The efficacy and safety of SIMPAP are similar to bubble CPAP in the first 6 h and up to 72 h for treating respiratory distress in preterm neonates.