Swaddle bathing versus conventional tub bathing for preterm infants
Effects of Swaddle Bathing on Physiological Regulation and Stress-Reducing Behaviors in Preterm Infants in the Neonatal Intensive Care Unit: A Randomized Controlled Trial
This pilot tests whether swaddle bathing helps preterm infants keep steadier temperature, heart rate, and oxygen levels and show less stress than conventional tub bathing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 1 Day to 7 Days |
| Sex | All |
| Sponsor | Chang Gung University of Science and Technology Academic / other |
| Locations | 1 site (Hsinchu) |
| Trial ID | NCT07522892 on ClinicalTrials.gov |
What this trial studies
This pilot randomized controlled trial in a NICU randomly assigns clinically stable preterm infants to either swaddle bathing or conventional tub bathing to compare physiological safety and behavioral comfort. Block randomization is used and all baths are performed by trained neonatal nurses with continuous monitoring of temperature, heart rate, and oxygen saturation as well as standardized behavioral stress scoring. Baths are conducted under controlled environmental conditions (room 25–26°C, water 39–40°C, standardized basin, 5-minute duration) and timed relative to feeds to minimize confounding. The primary aim is to show swaddle bathing is non-inferior for physiological stability and to provide preliminary data on whether it reduces stress-related behaviors during routine care.
Who should consider this trial
Good fit: Clinically stable preterm infants born at 32 to 36 weeks and 6 days gestation, weighing more than 1,500 grams and receiving their first postnatal bath, are eligible.
Not a fit: Infants with major congenital anomalies, severe (Grade III/IV) intraventricular hemorrhage, open skin wounds or surgical sites, or those on continuous sedatives or muscle relaxants are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, swaddle bathing could help preterm infants remain more physiologically stable and experience less stress during routine baths, improving comfort and potentially supporting neurodevelopmental care.
How similar studies have performed: Prior neonatal studies of gentle or swaddled bathing approaches have reported improved thermal and behavioral stability in some cohorts, but randomized comparisons specifically against conventional tub bathing are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * 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 Exclusion Criteria * 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 this trial is running
Hsinchu
- Hsinchu Mackay Children's Hospital — Hsinchu, Taiwan (Recruiting)
Study contacts
- Principal investigator: Tsai-Ling Lin, MSN — Hsinchu MacKay Children's Hospital
- Study coordinator: Ying-Mei Liu, PhD
- Email: ymliu@mail.cgust.edu.tw
- Phone: +886-32118999
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.