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NCT Number: NCT07445139

THE EFFECT OF BATHING METHODS APPLIED TO NEWBORNS ON VITAL SIGNS

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.

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Key information

Conditions

Age range

0 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sultangazi Haseki Training and Research Hospital

Istanbul, Sultangazi, 34265, Turkey (Türkiye)

Location contact

Dilara Erdoğan, BSc

CONTACT

[email protected]

+905448054615

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sponge bath of newborns

Procedure

Newborns bathed using a sponge bath among the types of baths

immersion bath of newborns

Procedure

Newborns bathed using a immersion bath among the types of baths

swaddle bath of newborns

Procedure

Newborns bathed using a swaddle bath among the types of baths

Primary outcomes

  1. 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

  1. Heart rate

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

    heart rate measured using standard neonatal monitoring equipment

  2. respiratory rate

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

    respiratory rate measured through clinical observation

  3. oxygen saturation

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

    peripheral oxygen saturation measured using pulse oximetry

Study contacts

Contact information is provided by the study sponsor or research team.

Dilara Erdoğan, BSc

CONTACT

[email protected]

+905448054615

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 3, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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