Short-term and long-term effects of skin-to-skin contact in healthy term infants: study protocol for a parallel-group double-blind randomised controlled trial.

Abstract

Mother-infant skin-to-skin contact (SSC) improves developmental and cognitive outcomes in preterm infants. However, the effects of SSC on healthy term infants remain unclear. We aim to investigate the short-term and long-term impacts of SSC in full-term infants to provide supporting data emphasising the importance of mother-infant SSC in South Korea. This study is a prospective, double-blind, randomised controlled trial. A total of 130 mothers and their healthy term infants will be recruited after birth. Participants will be randomised to the intervention (SSC) or control groups. Participants in both groups will be instructed on general newborn care guidance and requested to record the same in a mobile diary app daily for 2 weeks after hospital discharge. The intervention group will be educated on the importance and clinical advantages of mother-infant SSC and provided with practical guidance, along with an informational pamphlet. They will also be informed to engage in a minimum of 6 hours of SSC per day with the infant's and mother's chests exposed and in contact for at least 15 min per session and to keep a record of the contact time. Breastfeeding rate, time spent on SSC and holding clothed infant, maternal depression, anxiety and bonding scores will be measured. Infants' growth, temperament and neurodevelopmental outcomes will be assessed. In addition, artificial intelligence algorithms will be developed to analyse infant movements captured in videos. This study was approved by the institutional review board of the Korea University Anam Hospital (2024AN0613), and the results will be disseminated through scientific conferences and publications. NCT06777524, registered on 14 January 2025.