Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07522892 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Physiological Safety and Behavioral Comfort of Swaddle Bathing in Preterm Infants

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 14, 2026 (before its estimated May 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Re-verified, no change to tracked fieldsv2
  2. Minor Study First Submitted
Background and Purpose: Bathing is a routine but essential part of care for preterm infants in the Neonatal Intensive Care Unit (NICU). However, traditional tub bathing can be a significant source of stress for these vulnerable infants, potentially leading to fluctuations in body temperature, heart rate, and oxygen levels. Swaddle bathing-a technique where the infant is wrapped in a light cloth during the bath-is thought to provide a sense of security and better physiological stability. The goal of this pilot randomized controlled trial is to compare the effects of swaddle bathing versus conventional tub bathing in preterm infants. The researchers want to determine if swaddle bathing is as safe as traditional methods while being more comfortable for the baby. Main Questions to Answer: * Is swaddle bathing non-inferior to (as safe as) conventional tub bathing regarding the infant's physiological stability (e.g., body temperature and heart rate)? * Does swaddle bathing significantly reduce stress-related behaviors and crying in preterm infants compared to conventional bathing? Study Design and Procedure: Participants will be randomly assigned to one of two groups: 1. Experimental Group: Infants will receive swaddle bathing, where they remain snugly wrapped in a towel or wrap while being gently immersed in water. 2. Control Group: Infants will receive conventional tub bathing according to standard hospital protocols. During and after the bath, the research team will monitor the infants' vital signs and video-record their behavioral responses (such as facial expressions and limb movements) to evaluate their level of comfort and stress. The results of this study will provide preliminary evidence to help clinical nurses decide the best bathing practices for promoting the neurodevelopmental care of preterm infants.
Trial Details
NCT Number NCT07522892
Lead Sponsor Chang Gung University of Science and Technology
Conditions
(from sponsor)
Preterm Infants
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov