Repeated versus selective tactile stimulation for preterm infants at birth: protocol and statistical analysis plan for a stepped-wedge cluster randomised controlled trial (NEU-stim trial).

introductionPreterm infants frequently receive support for inadequate breathing at birth. Though current guidelines recommend using tactile stimulation to promote breathing, guidance on its use is limited. There are few studies on the effects of tactile stimulation with a high risk of bias in these studies. We aim to generate robust evidence by comparing the effects of repeated to selective tactile stimulation of preterm infants at birth in a stepped-wedge cluster randomised study. METHODS AND ANALYSIS: This stepped-wedge cluster randomised trial is being conducted from 11 March 2024 in 43 centres across Europe. All centres begin in the selective stimulation (control) arm, where stimulation is applied only when breathing effort is judged inadequate by treating clinicians. Every fortnight, one centre switches to the repeated stimulation (intervention) arm, where stimulation is provided for 10 s, alternated with 10-second pauses for at least the first 5 min after birth. Once centres switch, they continue in the repeated stimulation arm until study completion. The order of switching is prospectively and randomly assigned, with the last switch occurring on 24 November 2025. The primary outcome is achievement of a pre-ductal oxygen saturation ≥80% at 5 min after birth. Analyses will use generalised linear mixed models to compare outcomes between groups at the individual level. ETHICS AND DISSEMINATION: Ethical approval was obtained at all participating centres. The study adheres to the Declaration of Helsinki, the principles of Good Clinical Practice and the General Data Protection Regulation. Results will be shared with investigators, published in a peer-reviewed journal and presented at national and international conferences. TRIAL REGISTRATION NUMBER: NCT05942924.