Набор скоро начнётся NCT07445139

THE EFFECT OF BATHING METHODS APPLIED TO NEWBORNS ON VITAL SIGNS

Без фазы С лечением Healthy Newborns

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: sponge bath of newborns, immersion bath of newborns, swaddle bath of newborns.
Кому может быть актуально: Состояния в реестре: Healthy Newborns. Базовые параметры: 0 Days — 28 Days · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Turkey (Türkiye)
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

Процедура sponge bath of newborns
Newborns bathed using a sponge bath among the types of baths
Процедура immersion bath of newborns
Newborns bathed using a immersion bath among the types of baths
Процедура swaddle bath of newborns
Newborns bathed using a swaddle bath among the types of baths

Первичные конечные точки

Neonatal body temperature [Срок оценки: Baseline (before bathing), immediately after bathing, and at 5, 10, 30 and 60 minutes after bathing]

Вторичные конечные точки (3)

Heart rate [Срок оценки: Baseline (before bathing), immediately after bathing, and at 5, 10, 30 and 60 minutes after bathing]
respiratory rate [Срок оценки: Baseline (before bathing), immediately after bathing, and at 5, 10, 30 and 60 minutes after bathing]
oxygen saturation [Срок оценки: Baseline (before bathing), immediately after bathing, and at 5, 10, 30 and 60 minutes after bathing]

Критерии участия

Критерии включения

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