Biobehavioral Efficacy of the Elevated Side-Lying Position for Feeding Preterm Infants: Study Protocol.

Aim: Present a study protocol investigating the biobehavioral efficacy of side-lying vs. supine positions on physiologic and behavioural responses of preterm infants during their transition from tube to full oral feeding, and identify associated infant characteristics.

Design: Within-subject cross-over design.

Methods: Sixty preterm infants born at ≤35 weeks gestational age (GA) from a level 3 NICU are observed during their transition to full oral feeding. Each undergoes two feedings within 24 h: One in the supine position and one in the side-lying position. Continuous physiologic and video data are collected 30 min before and after feeding. Physiologic measures include heart rate, respiratory rate, oxygen saturation, and autonomic nervous system regulation (heart rate variability and splanchnic-cerebral oxygen ratio). Behavioural responses are assessed via microanalysis of the sucking and breathing waveforms and videotaped feedings (Suck-breathe coordination and Early Feeding Skills assessment tool). Data are analysed using linear mixed-effects models. IRB was obtained in September 2021, with funding awarded by the National Institute of Nursing Research in July 2021.

Conclusion: This study will enhance our understanding of the effects of the side-lying position on preterm infant feeding, providing guidance for its clinical use as a feeding strategy.

Implications: Provides vital knowledge to guide evidence-based practices in enhancing oral feeding in preterm infants and inform future pivotal efficacy trials.

Impact: If effective, this intervention could significantly enhance the management of feeding challenges in preterm infants across neonatal care settings.

Reporting method: Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013.

Patient or public contribution: While direct parent involvement was not documented in our protocol, informal feedback on data collection procedures from parents was incorporated. Additionally, extensive engagement with healthcare professionals during study design addressed patient safety, logistical challenges, and ethical standards in NICU settings.

Trial registration: ClinicalTrials.gov identifier: NCT04942106; registered on 28 June 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT04942106.