Physiological Safety and Behavioral Comfort of Swaddle Bathing in Preterm Infants

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.

Conditions

• Preterm Infants

Interventions

OTHER

Swaddle Bathing

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.

OTHER

Conventional Tub Bathing

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.

Sponsors & Collaborators

• Chang Gung University of Science and Technology

  lead OTHER

Principal Investigators

• Tsai-Ling Lin, MSN · Hsinchu MacKay Children's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

1 Day

Max Age

7 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-24

Primary Completion

2026-05-31

Completion

2026-05-31

Countries

• Taiwan

Study Locations