THE EFFECT OF BATHING METHODS APPLIED TO NEWBORNS ON VITAL SIGNS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: sponge bath of newborns, immersion bath of newborns, swaddle bath of newborns.
- Who it may be relevant to
- Registry conditions: Healthy Newborns. Basic parameters: 0 Days — 28 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
THE EFFECT OF BATHING METHODS APPLIED TO NEWBORNS ON VITAL SIGNS: A RANDOMIZED CONTROLLED TRIAL
Overview
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.
Interventions
- Procedure sponge bath of newborns
Newborns bathed using a sponge bath among the types of baths - Procedure immersion bath of newborns
Newborns bathed using a immersion bath among the types of baths - Procedure swaddle bath of newborns
Newborns bathed using a swaddle bath among the types of baths
Primary outcome measures
- Neonatal body temperature [Time frame: Baseline (before bathing), immediately after bathing, and at 5, 10, 30 and 60 minutes after bathing]
Secondary outcome measures (3)
- Heart rate [Time frame: Baseline (before bathing), immediately after bathing, and at 5, 10, 30 and 60 minutes after bathing]
- respiratory rate [Time frame: Baseline (before bathing), immediately after bathing, and at 5, 10, 30 and 60 minutes after bathing]
- oxygen saturation [Time frame: Baseline (before bathing), immediately after bathing, and at 5, 10, 30 and 60 minutes after bathing]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Turkey (Türkiye) · 1 center
- Sultangazi Haseki Training and Research Hospital — Istanbul
Identifiers
NCT: NCT07445139 · 546724004