About this 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Swaddle Bathing
- Conventional Tub Bathing