A Randomised Trial of Repetitive Versus Selective Tactile Stimulation for Preterm Infants Born Before 32 Weeks: The NEU-STIM Trial

What this Trial Is About

Researchers are evaluating the impact of repetitive tactile stimulation compared to selective stimulation on the oxygen levels of preterm infants born before 32 weeks of gestation. This study uses a stepped-wedge cluster randomized controlled design, where entire centers switch from selective to repetitive stimulation over time. The goal is to see if repetitive stimulation improves oxygenation at 5 minutes after birth, based on prior evidence suggesting it may enhance respiratory effort and reduce the need for invasive support. Initially, participating centers will apply selective tactile stimulation by gently rubbing the infant's back, chest, limbs, or soles only if breathing seems insufficient. Later, centers are randomly assigned to switch to repetitive stimulation, involving 10-second gentle rubbing followed by 10 seconds of rest, repeated for the first 5 minutes after birth or longer if needed. All other care procedures in the delivery room and neonatal intensive care unit follow standard guidelines throughout the study. During the trial, infants will be monitored closely with measures including oxygen saturation at 5 minutes after birth, heart rate, and respiratory support interventions such as CPAP and mechanical ventilation during the first minutes and week after birth. Additional assessments include cranial ultrasound and recording of interventions like surfactant administration. The study aims to understand how different tactile stimulation methods affect early oxygenation and respiratory outcomes in very preterm infants, with participation lasting through the first week after birth.

The NEU-STIM Trial