Physiological Safety and Behavioral Comfort of Swaddle Bathing in Preterm Infants

Recruiting now · Not applicable

Conditions studied: Preterm Infants

In brief

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.

Key facts

Study ID

NCT07522892

Run by

Chang Gung University of Science and Technology

People needed

40

Starts

2024-04-24

Expected to finish

2026-05-31

Last updated by the study team

2026-04-14

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Gestational age between 32 and 36 weeks and 6 days
• Birth weight greater than 1,500 grams
• Clinically stable as determined by the attending neonatologist
• Receiving the first bath after birth

You may not qualify if…

• Major congenital anomalies, such as cyanotic heart disease, gastroschisis, or open spinal defects
• Severe intraventricular hemorrhage (Grade III or IV)
• Skin impairments or open wounds that contraindicate water immersion, including surgical sites
• Continuous use of sedatives or muscle relaxants that may interfere with behavioral assessments

Where it is running

• Hsinchu Mackay Children's Hospital — Hsinchu, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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