Physiological Safety and Behavioral Comfort of Swaddle Bathing in Preterm Infants

NCT07522892 | Recruiting

• 2 other identifiers: 23MMHIS389e20231100016
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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:
• Experimental Group: Infants will receive swaddle bathing, where they remain snugly wrapped in a towel or wrap while being gently immersed in water.
• Control Group: Infants will receive conventional tub bathing according to standard hospital protocols.

Conditions

Preterm Infants

Keywords

swaddle bath; preterm infants

Outcome Measures

Primary Outcomes (2)

• Behavioral Stress Scores

  Behavioral stress is assessed using a checklist based on the Newborn Individualized Developmental Care and Assessment Program (NIDCAP) principles (Als \& McAnulty, 2011), adapted from the Taiwan Society of Neonatology Developmental Care Manual (Taiwan Society of Neonatology, 2021). Assessment: The frequency of 10 stress-related behaviors (including motor and neurophysiological cues) is recorded during the 5-minute bathing procedure. Scoring: The Behavioral Stress Score is calculated as the sum of all observed behavioral frequencies. The total score ranges from 0 with no theoretical maximum. A higher cumulative frequency (score) indicates greater behavioral stress in the preterm infant.

  During the 5-minute bathing procedure

• Body Temperature

  baseline (pre-bath), immediately post-bath, and 10 minutes post-bath.

Secondary Outcomes (3)

• Heart Rate

  baseline (pre-bath), immediately post-bath, and 10 minutes post-bath.

• Percentage of Crying Time

  During the 5-minute bathing procedure

• oxygen saturation

  baseline (pre-bath), immediately post-bath, 10 minutes post-bath

Study Arms (2)

Swaddle Bathing

EXPERIMENTAL

Preterm infants in this group will receive swaddle bathing, a developmental care intervention designed to maintain physiological stability and reduce stress during the bathing process.

Other: Swaddle Bathing

Conventional Tub Bathing

ACTIVE COMPARATOR

Preterm infants in this group will receive the standard conventional tub bathing according to the hospital's current clinical protocol.

Other: Conventional Tub Bathing

Interventions

Swaddle Bathing OTHER

Experimental Group: Swaddle Bathing The swaddle bathing intervention is a developmental care procedure designed to enhance neurodevelopmental stability. To ensure consistency, the bath is performed 30-60 minutes before or 1 hour after feeding in a 25-26°C temperature-controlled environment. The infant is snugly wrapped in a thin cotton cloth (swaddle) and gently immersed into a standardized stainless-steel basin (33 cm diameter, 10 cm height) filled with 39-40°C water. During the strictly 5-minute procedure, the nurse uncoils the wrap only partially to wash specific body parts. This method distinguishes itself by maintaining the infant in a contained, secure, and flexed midline position throughout the immersion, minimizing physiological and behavioral stress.

Swaddle Bathing

Conventional Tub Bathing OTHER

Control Group: Conventional Tub Bathing Infants in this group receive standard hospital tub bathing. To control for confounding variables, the environment and timing are identical to the experimental group: 30-60 minutes before or 1 hour after feeding at an ambient temperature of 25-26°C. The infant is undressed and placed directly into the same standardized stainless-steel basin (33 cm diameter, 10 cm height) with water at 39-40°C. The nurse provides manual support to the infant's head and body according to standard NICU protocol but without any stabilizing wrap or cloth containment. The procedure is strictly limited to 5 minutes. Unlike the experimental group, the infant's skin is directly exposed to the water and air without the tactile support of a swaddle.

Conventional Tub Bathing

Eligibility Criteria

• Age: 1 Day - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Chang Gung University of Science and Technology: lead

Study Sites (1)

Hsinchu Mackay Children's Hospital

Hsinchu, 300, Taiwan

RECRUITING

Related Publications (3)

• Sun, X., Xu, J., Zhou, R., Liu, B., & Gu, Z. (2023). Effectiveness of different bathing methods on physiological indexes and behavioral status of preterm infants: A systematic review and meta-analysis. BMC Pediatrics, 23(1), 507. https://doi.org/10.1186/s12887-023-04280-y

  BACKGROUND

• Fernández, D., & Antolín-Rodríguez, R. (2018). Bathing a premature infant in the intensive care unit: A systematic review. Journal of Pediatric Nursing, 42, e52-e57. https://doi.org/10.1016/j.pedn.2018.05.002

  BACKGROUND

• Chandebois, L., Nogue, E., Bouschbacher, C., Durand, S., Masson, F., Mesnage, R., Nagot, N., & Cambonie, G. (2021). Dissemination of newborn behavior observation skills after Newborn Individualized Developmental Care and Assessment Program (NIDCAP) implementation. Nursing Open, 8(6), 3547-3557. https://doi.org/10.1002/nop2.904

  BACKGROUND

Study Officials

• Tsai-Ling Lin, MSN

  Hsinchu MacKay Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying-Mei Liu, PhD

CONTACT

+886-32118999; ymliu@mail.cgust.edu.tw

Tsai-Ling Lin, MSN

CONTACT

+886-912531009; M401@mmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 13, 2026
• Study Start: April 24, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)