NCT07522892 Physiological Safety and Behavioral Comfort of Swaddle Bathing in Preterm Infants
| NCT ID | NCT07522892 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chang Gung University of Science and Technology |
| Condition | Preterm Infants |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-04-24 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-04-24 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Tsai-Ling Lin, MSN
PRINCIPAL INVESTIGATOR
Hsinchu MacKay Children's Hospital
Frequently Asked Questions
Who can join the NCT07522892 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 7 Days, studying Preterm Infants. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07522892 currently recruiting?
Yes, NCT07522892 is actively recruiting participants. Contact the research team at ymliu@mail.cgust.edu.tw for enrollment information.
Where is the NCT07522892 trial being conducted?
This trial is being conducted at Hsinchu, Taiwan.
Who is sponsoring the NCT07522892 clinical trial?
NCT07522892 is sponsored by Chang Gung University of Science and Technology. The principal investigator is Tsai-Ling Lin, MSN at Hsinchu MacKay Children's Hospital. The trial plans to enroll 40 participants.