The effect of delaying first bathing on skin barrier function in late preterm infants: A study protocol for multi-centre, single-blind RCT.

AIMS The study aims to examine the effect of delaying first bathing on skin barrier function, body temperature, and neonatal comfort of late preterm infants. DESIGN This study is a multi-centre, single-blind, prospective randomized controlled trial. METHODS We attempt to report this randomized controlled trial to comply with the SPIRIT. The study population will consist of 80 late preterm infants born at three centres (hospitals) in Turkey. The study, between September 2020-September 2021 will be held in the Neonatal Intensive Care Unit. The participants will be randomly divided into two groups, each with different bathing times. The first group (N = 40) will be bathed between 24-48 hr after birth and the second group (N = 40) will be bathed between 48-72 hr after birth. Each group's intervention will be performed by a blinded researcher. The infants' transepidermal water loss, body temperature, and comfort level will be measured before the bath and again at three times after the bath. The measurements will be taken by a blinded researcher and blinded nurse. DISCUSSION The benefits of infant bathing are known. However, the effect of delaying first bathing of late preterm infants on skin barrier function is unknown. At the same time, the effect of delaying bathing on maintaining body temperature and neonatal comfort is unknown. IMPACT This study is expected to provide a piece of credible evidence of the delay of first bathing and benefit of neonatal care in this population. It is thought that postponing bathing time of late preterm infants to 48-72 hr after birth will lead to a protective effect on skin barrier and temperature. It will be performed in clinical practice if it can effectively improve transepidermal water loss and heat loss. TRIAL REGISTRATION It was registered at ClinicalTrials.gov in January 2020 (NCT04231799).