Actively Recruiting

Phase Not Applicable
Age: 1Day - 7Days
All Genders
ID07522892

Effects of Swaddle Bathing on Physiological Regulation and Stress-Reducing Behaviors in Preterm Infants in the Neonatal Intensive Care Unit: A Randomized Controlled Trial

Led by Chang Gung University of Science and Technology · Updated on 2026-04-14

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare swaddle bathing and conventional tub bathing in preterm infants cared for in the Neonatal Intensive Care Unit (NICU). The study focuses on whether swaddle bathing, which involves wrapping the infant in a light cloth during the bath, provides similar physiological safety and greater comfort compared to traditional bathing. Researchers will evaluate if this method helps maintain body temperature and heart rate while reducing stress and crying in these vulnerable babies. Participants will be randomly assigned to either the experimental group receiving swaddle bathing or the control group receiving conventional tub bathing. Baths are scheduled in a temperature-controlled room with water at 39-40 0C and last exactly 5 minutes. In the swaddle bathing group, infants remain wrapped and only partially unwrapped for washing, while the control group infants are undressed and bathed without a wrap following hospital protocols. During and after bathing, infants' body temperature, heart rate, and oxygen saturation will be closely monitored using calibrated devices. Behavioral responses such as crying and stress-related movements will be video-recorded and scored using standardized scales. Data will be gathered at baseline, immediately after the bath, and 10 minutes later to assess physiological stability and comfort. The trial will provide important preliminary information to guide best bathing practices for preterm infants.

CONDITIONS

Brief Title

Physiological Safety and Behavioral Comfort of Swaddle Bathing in Preterm Infants

Who Can Participate

Age: 1Day - 7Days
All Genders

Eligibility Criteria

Eligible

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
  • Age between 1 and 7 days
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single 5-minute bathing procedure

Participants receive either swaddle bathing or conventional tub bathing. The bathing procedure is performed in a controlled environment, lasts 5 minutes, and is scheduled 30 to 60 minutes before or 1 hour after feeding to maintain consistency and reduce stress.

1 bathing visit (in-person)

Follow-up

Duration - 10 minutes post-bath

Participants are observed and assessed immediately after the bath and 10 minutes post-bath to monitor physiological stability and behavioral comfort.

Assessments immediately post-bath and 10 minutes post-bath during the same visit

Trial Site Locations

Total: 1 location

1

Hsinchu Mackay Children's Hospital

Hsinchu, Taiwan, 300

Actively Recruiting

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Research Team

Y

Ying-Mei Liu, PhD

T

Tsai-Ling Lin, MSN

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

Effectiveness of different bathing methods on physiological indexes and behavioral status of preterm infants: a systematic review and meta-analysis.

Xing Sun, Jiayi Xu, Ruhua Zhou...

https://pubmed.ncbi.nlm.nih.gov/37828460

Dissemination of newborn behavior observation skills after Newborn Individualized Developmental Care and Assessment Program (NIDCAP) implementation.

Laurence Chandebois, Erika Nogue, Catherine Bouschbacher...

https://pubmed.ncbi.nlm.nih.gov/33956404