Back rubs or foot flicks for neonatal stimulation at birth in a low-resource setting: A randomized controlled trial

Background: Approximately 15% of infants require stimulation in low-resource settings, but data on effectiveness of different stimulation approaches are limited. We aimed to compare two recommended approaches of stimulation (back rubs vs. foot flicks) in reducing the need for face-mask ventilation in newly born infants who were not crying immediately after birth in a low-resource setting. Methods: A single center, open-label, randomized, superiority trial was conducted at St. Kizito Hospital in Matany (Uganda) between November 2019 and May 2020. Newly born infants with expected birthweight > 1500 grams who were not crying immediately after birth were randomly assigned to stimulation using back rubs or foot flicks. The primary outcome measure was the success rate of the stimulation, defined as the achievement of an effective crying preventing the need for face-mask ventilation. Results: Success of stimulation was achieved in 76/93 neonates (82%) using back rubs and 68/93 neonates (73%) using foot flicks (risk ratio 1.12, 95% confidence interval 0.96–1.31). No procedure-associated complications arose during the study. Time to first cry was not statistically different between the two arms (mean difference −11 seconds, 95% confidence interval −39 to 18). Conclusions: In newly born infants who were not crying immediately after birth, this trial did not provide a conclusive message in favor of back rubs or foot flicks. Nonetheless, we could not exclude a possible benefit of back rubs in avoiding the need for positive pressure ventilation and, possibly, further advanced resuscitative maneuvers. Clinical trials registration: clinicalTrial.gov: NCT04056091.