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Clinical Trials/NCT07445139
NCT07445139Not yet recruitingNot Applicable

THE EFFECT OF BATHING METHODS APPLIED TO NEWBORNS ON VITAL SIGNS: A RANDOMIZED CONTROLLED TRIAL

Marmara University1 site in 1 country107 target enrollmentStarted: March 1, 2026Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
107
Locations
1
Primary Endpoint
Neonatal body temperature

Study Overview

Brief Summary

The neonatal mortality rate is a global issue and an important indicator reflecting the quality and accessibility of a country's healthcare system.

The main causes of death in newborns include premature birth, birth complications (birth asphyxia/trauma), and neonatal infections. Neonatal hypothermia is also associated with increased neonatal mortality. Therefore, the World Health Organization (WHO) has recommended a comprehensive neonatal care protocol to improve health outcomes for newborns. This protocol includes management steps such as emergency care at birth (delayed cord clamping, thorough drying, respiratory assessment, skin-to-skin contact, early initiation of breastfeeding), infection prevention, and thermal care (prevention of hypothermia).

Hypothermia is a condition in newborns where a drop in body temperature can lead to serious health problems such as metabolic acidosis, hypoglycemia, respiratory distress, hypoxia, bradycardia, hypotension, and infection. It is known that bathing newborns early on is therefore a significant risk factor for hypothermia in newborns.

Bathing newborns stimulates skin circulation, providing relaxation and a sense of well-being. It also contributes to the regulation of respiration and circulation, improvement of cell metabolism and capillary permeability, reduction of pain, increase in intestinal peristalsis, and decrease in bilirubin levels.

On the other hand, during bathing, light, noise, changes in ambient temperature, stress, and increased crying may cause thermal and cardiorespiratory changes in the newborn, such as heart rate, body temperature, respiratory rate, and oxygen saturation.

Delaying the first bath for at least 24 hours in newborns has been associated with reducing hypothermia and excessive crying, as well as benefiting from the vernix caseosa on the skin. Therefore, bathing under appropriate conditions and at the right time is critically important for newborn health.

Another important issue is the methods used for bathing newborns. There are various methods, such as tub bathing, sponge bathing, swaddling bathing, cradle bathing, bathing under running water, and oil bathing.

However, there was a need for more high-level evidence regarding the effect of different bathing methods used in term newborns on newborn health outcomes, and it was decided to conduct this study.

This study will provide important data for basing newborn care protocols on scientific evidence and improving clinical practices.

This randomized controlled study will compare immersion bathing (control group), swaddled bathing, and sponge bathing in term newborns to evaluate their effects on vital signs such as body temperature, heart rate, respiratory rate, and oxygen saturation.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
0 Days to 28 Days (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Hospitalized in the Level I Neonatal Intensive Care Unit of Sultangazi Haseki Training and Research Hospital
  • Aged between 0-28 days
  • 5-minute APGAR score ≥ 7
  • Born at term (37-42 weeks of gestation)
  • Birth weight ≥ 2500 grams
  • No life-threatening condition
  • No history of surgical procedures
  • Stable vital signs within the last 24 hours
  • Written informed consent obtained from the mother

Exclusion Criteria

  • Presence of congenital anomalies
  • Presence of impaired skin integrity or open wounds
  • Receiving mechanical ventilation or intubated
  • Withdrawal of consent by the mother

Arms & Interventions

immersion bath of newborns

Experimental

Newborns bathed using a immersion bath among the types of baths

Intervention: immersion bath of newborns (Procedure)

swaddle bath of newborns

Experimental

Newborns bathed using a swaddle bath among the types of baths

Intervention: swaddle bath of newborns (Procedure)

sponge bath of newborns

Experimental

Newborns bathed using a sponge bath among the types of baths

Intervention: sponge bath of newborns (Procedure)

Outcomes

Primary Outcomes

Neonatal body temperature

Time Frame: Baseline (before bathing), immediately after bathing, and at 5, 10, 30 and 60 minutes after bathing

Forehead body temperature measured using non-contact infrared thermometer

Secondary Outcomes

  • Heart rate(Baseline (before bathing), immediately after bathing, and at 5, 10, 30 and 60 minutes after bathing)
  • respiratory rate(Baseline (before bathing), immediately after bathing, and at 5, 10, 30 and 60 minutes after bathing)
  • oxygen saturation(Baseline (before bathing), immediately after bathing, and at 5, 10, 30 and 60 minutes after bathing)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dilara Erdoğan

msc midwifery student

Marmara University

Study Sites (1)

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