Early father-infant skin-to-skin contact and its effect on the neurodevelopmental outcomes of moderately preterm infants in China: study protocol for a randomized controlled trial.

BACKGROUND: Skin-to-skin contact (SSC) is an evidence-based intervention that benefits low birth weight /preterm infants. However, China's health institutional policy inhibits parents from visiting their baby in the neonatal intensive care unit (NICU). In addition, the Chinese traditional postpartum behavioral practice of confining women to home raises barriers to mother-infant contact. Thus, to shorten the duration of parent-infant separation, father-infant SSC is considered a possible alternative. This study determines whether it is safe to perform father-infant SSC in the NICU and investigates how paternal SSC affects outcomes compared with traditional care (TC) for moderately preterm infants.

METHODS/DESIGN: A randomized controlled trial will be used to investigate the effects of paternal-infant SSC in NICU wards in China. Preterm infants born at a gestational age in the range of 320 -346  weeks with a birth weight > 1500 g will be eligible. A simple random sampling method will be used to allocate infants to the SSC group (n = 25) or the TC group (n = 25). After medical stability, infants in the SSC group will be provided SSC by fathers for one hour every day until discharged from hospital. The primary outcome is neurodevelopmental measures, specifically salivary cortisol and Premature Infant Pain Profile (PIPP) during hospitalization. At 40 weeks of corrected age, infants will be assessed using the Infant Neurological International Battery (INFANIB) and neuroimaging. Secondary outcomes include infants' physiological stability during SSC and throughout hospitalization and state observation at discharge. The fathers' mental health will be assessed with the State-Trait Anxiety Inventory (STAI) 1 day to 3 days after the infant's admission to the NICU and at discharge. Father-infant attachment will be evaluated at 4 and 6 months after the infants' discharge, measured by the Paternal Postnatal Attachment Scale (PPAS). Statistical analyses will be conducted using a two-sided significance level of 0.05.

DISCUSSION: The effects of paternal-infant SSC on moderately preterm infants will be assessed. The data gathered in this study may have important implications for medical practice and policy in the NICU regarding the care methods of premature infants in China.

TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR-IOR-1701274 . Registered on 20 September 2017. Retrospectively registered.