Actively Recruiting
Physiological Safety and Behavioral Comfort of Swaddle Bathing in Preterm Infants
Led by Chang Gung University of Science and Technology · Updated on 2026-04-14
40
Participants Needed
1
Research Sites
109 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Physiological Safety and Behavioral Comfort of Swaddle Bathing in Preterm Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hsinchu Mackay Children's Hospital
Hsinchu, Taiwan, 300
Actively Recruiting
Research Team
Y
Ying-Mei Liu, PhD
CONTACT
T
Tsai-Ling Lin, MSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here