Physiological Safety and Behavioral Comfort of Swaddle Bathing in 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

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.

Study Overview

• Status: Recruiting
• Conditions: Preterm Infants
• Intervention / Treatment: Other: Swaddle Bathing; Other: Conventional Tub Bathing

Detailed Description

Study Overview:

This pilot randomized controlled trial (RCT) aims to evaluate the physiological safety and behavioral comfort of swaddle bathing compared to conventional tub bathing in preterm infants. The study is designed to provide preliminary evidence on whether swaddle bathing serves as a neurodevelopmental care intervention that maintains thermal and cardiovascular stability while reducing stress-related behaviors during a routine nursing procedure in the Neonatal Intensive Care Unit (NICU).

Research Methodology:

Participants will be recruited from a NICU and randomly assigned to either the experimental group (swaddle bathing) or the control group (conventional tub bathing) using a block randomization method. To ensure safety, all bathing procedures will be conducted by trained neonatal nurses and monitored for any signs of physiological distress.

Intervention Protocols:

Standardized Environmental Conditions To minimize the confounding effects of hunger or satiety on behavioral responses, all baths were scheduled approximately 30 to 60 minutes before the next scheduled feeding (or 1 hour after feeding). To ensure consistency across both groups, all bathing procedures were conducted in a temperature-controlled environment maintained at 25-26°C. A standardized stainless-steel basin (33 cm diameter, 10 cm height) was filled to 80% capacity with water at 39-40°C. The duration of the bathing procedure was strictly limited to 5 minutes for all participants.

1. Experimental Group (Swaddle Bathing): The infant is snugly wrapped in a thin cotton cloth or swaddle. While maintaining the wrap, the infant is gently immersed into a tub of warm water (39 to 40°C). The nurse uncoils the wrap only partially to wash specific body parts, ensuring the infant remains contained and secure throughout the process.
2. Control Group (Conventional Tub Bathing): The infant is undressed and placed directly into the tub according to standard hospital protocol, with the nurse providing manual support but without the use of a stabilizing wrap.

Data Collection and Outcome Measurement:

The study will record data at three time points: baseline (pre-bath, T0), immediately post-bath (T1), and 10 minutes post-bath (T2).

• Physiological Safety:

  • Body Temperature: Measured using a rapid electronic thermometer (verified by the Bureau of Standards, Metrology and Inspection, MOEA; License No. 001618). Axillary temperature was measured, with the device remaining in place for 3-5 minutes after the beep to ensure accuracy.
  • Vital Signs Monitoring: Heart rate (HR) and oxygen saturation (SpO2) were measured using a General Electric B105 portable physiological monitor (License No. 022655). The device is calibrated and maintained every six months by biomedical engineers.
• Behavioral Comfort: Infants will be video-recorded to assess stress signals and comfort levels. Blinded observers will use standardized neonatal pain and stress scales (e.g., Anderson Behavioral State Scale) to score the frequency of crying and stress-related motor activities.

Statistical Analysis:

Data will be analyzed using descriptive statistics and generalized estimating equations (GEE) to account for the repeated measures over time. As a pilot study, the results will be used to calculate the effect size required for a future full-scale clinical trial.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ying-Mei Liu, PhD; Phone Number: 3230 +886-32118999; Email: ymliu@mail.cgust.edu.tw
• Study Contact Backup: Name: Tsai-Ling Lin, MSN; Phone Number: +886-912531009; Email: M401@mmh.org.tw

Study Locations

• Taiwan
  • Hsinchu, Taiwan, 300
    • Recruiting
    • Hsinchu Mackay Children's Hospital
    • Contact: Tsai-Ling Lin, MSN; Phone Number: +886-3-571-9999; Email: M401@mmh.org.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Swaddle Bathing; 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; 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.
Active Comparator: Conventional Tub Bathing; Preterm infants in this group will receive the standard conventional tub bathing according to the hospital's current clinical protocol.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Temperature		baseline (pre-bath), immediately post-bath, and 10 minutes post-bath.
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate	Heart rate is monitored using a General Electric (GE) B105 portable physiological monitor (License No. 022655). Data are recorded in beats per minute (bpm). The device undergoes professional calibration and maintenance every six months by biomedical engineers to ensure measurement accuracy.	baseline (pre-bath), immediately post-bath, and 10 minutes post-bath.
Percentage of Crying Time	The percentage of crying time is calculated by dividing the total duration of the infant's crying during the procedure by the total duration of the bathing procedure (5 minutes), and then multiplying by 100 to obtain a percentage (%). A higher percentage indicates greater behavioral distress during the intervention.	During the 5-minute bathing procedure
oxygen saturation	Oxygen saturation is measured via a General Electric (GE) B105 portable physiological monitor (License No. 022655) and recorded as a percentage (%). The monitor is regularly calibrated and maintained every six months by certified biomedical engineers to ensure consistent data quality during the neonatal bath.	baseline (pre-bath), immediately post-bath, 10 minutes post-bath

Collaborators and Investigators

• Sponsor: Chang Gung University of Science and Technology
• Investigators: Principal Investigator: Tsai-Ling Lin, MSN, Hsinchu Mackay Children's Hospital

Publications and helpful links

General Publications

• 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
• 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
• 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

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: March 30, 2026
• First Submitted That Met QC Criteria: April 4, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: preterm infants; swaddle bath
• Other Study ID Numbers: 23MMHIS389e; 20231100016 (Other Identifier: Institutional Review Board, MacKay Memorial Hospital, Taiwan)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No