Sustained Lung Inflation in Pre-term Infants at Birth: A Randomized Controlled Trial.

BACKGROUND

Invasive mechanical ventilation (IMV) of pre-term infants may be associated with high rate of mortality and iatrogenic complications in low- and middle-income countries. Sustained lung inflation (SLI) may help to reduce their need for IMV.

METHODS

This randomized controlled trial included 160 infants with gestational age (GA) ≥27 and ≤32 weeks who were randomly assigned to receive either SLI; using a pressure of 20 cmH2O for 15 s followed by nasal continuous positive airway pressure (CPAP) of 5 cmH2O or nasal CPAP alone, through an appropriate mask and a T-piece resuscitator. Primary outcome was the need for IMV in the first 72 h of life.

RESULTS

There was no difference in the primary outcome between SLI group; 55% (44 out of 80) and the control group; 65% (52 out of 80) [odds ratio (OR): 0.623, 95% confidence interval (CI): 0.33-1.18; p = 0.145]. However, SLI significantly reduced the primary outcome in the sicker infants; who had clinical eligibility criteria (CEC; OR: 0.224, 95% CI: 0.076-0.663; p = 0.005) and in the smaller babies; whose GA was <30 weeks (OR: 0.183, 95% CI: 0.053-0.635; p = 0.005).

CONCLUSION

SLI was not harmful. Although, it did not lead to reduction in the need for IMV in the first 72 h of life in pre-term infants with GA ≥27 and ≤32 weeks, SLI reduced this outcome in the subgroup of infants with CEC and those with GA <30 weeks. Future trials are needed to investigate the effect of SLI on these two subgroups.

TRIAL REGISTRATION

Clinical trials.gov, NCT03518762. https://www.clinicaltrials.gov/ct2/show/NCT03518762?term=NCT03518762&rank=1.