Impact of Kangaroo Care on Premature Infants' Circadian Rhythm, Growth, Physiological Stability, and Maternal Milk Hormones: RCT Protocol

BACKGROUND: Kangaroo care (KC) is considered to be an effective intervention in establishing circadian rhythms and human milk hormone profiles in premature infants. PURPOSE: This study protocol has 2 main objectives: to assess the effects of regular KC on circadian rhythm, growth, and physiological parameters in premature infants, and to evaluate human milk cortisol and melatonin levels as secondary outcomes. METHODS: This trial is a parallel-group, single-blind, randomized controlled experimental study. Sample of the study will consist of 56 premature infants. The experimental group (n = 28) will receive KC for 1 hour, twice daily, during designated day and night intervals over 3 consecutive days. The control group (n = 28) will receive routine incubator/cot care. The daytime and nighttime circadian rhythms of both groups will be monitored. Human milk samples will be collected from both groups to determine cortisol and melatonin levels in human milk. RESULTS: Protocol results are expected to advance knowledge by providing the first integrated assessment of circadian rhythm development in neonatal intensive care unit infants using noninvasive neurophysiological measures and human milk cortisol and melatonin. By linking these indicators to KC and assessing growth and physiological stability, the study will provide evidence on whether KC supports circadian rhythm maturation. IMPLICATIONS FOR PRACTICE AND RESEARCH: Research will guide clinicians in evaluating the effects of kangaroo care administered during daytime and nighttime intervals for 3 consecutive days on circadian rhythm, growth, physiological parameters, and human milk cortisol and melatonin levels, while also providing a foundation for future research.