Dry Cord Care Versus Alcohol Cord Care in 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: Routine Alcohol Cord Care, Natural Dry Cord Care.
- Кому может быть актуально
- Состояния в реестре: Umbilical Cord Infection, Newborn. 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
- Тайвань
- 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
Effects of Routine Umbilical Cord Care and Natural Drying Care on Neonatal Infection Rates, Cord Separation Time, and Cost-Effectiveness: A Randomized Controlled Trial
Обзор
Umbilical cord care is an essential component of newborn care, but the optimal method remains controversial. This randomized controlled trial aims to compare routine alcohol cord care with natural dry cord care in healthy newborns. A total of 210 mother-infant dyads will be randomly assigned to either routine alcohol cord care or natural dry cord care. The primary outcome is the incidence of umbilical cord infection. Secondary outcomes include umbilical cord separation time, bacterial colonization, and healthcare resource utilization for umbilical cord care. The findings of this study will provide evidence to support optimal umbilical cord care practices for healthy newborns.
Подробное описание
Umbilical cord infection remains an important cause of neonatal morbidity worldwide. Although the World Health Organization recommends dry cord care for healthy newborns born in healthcare facilities under hygienic conditions, routine alcohol cord care is still widely practiced in many hospitals. Evidence regarding the effectiveness of these two approaches in Taiwan remains limited.
This investigator-initiated, single-center, prospective, randomized controlled trial aims to compare routine alcohol cord care with natural dry cord care among healthy newborns delivered at New Taipei Municipal TuCheng Hospital. Healthy newborns who remain in the routine newborn nursery and are not admitted directly to the Newborn Care Center (NBC) or Pediatric Intensive Care Unit (PICU) will be eligible for enrollment. A total of 210 mother-infant dyads will be randomly assigned in a 1:1 ratio to either routine alcohol cord care or natural dry cord care using computer-generated randomization.
Newborns assigned to the routine alcohol cord care group will receive standard alcohol-based umbilical cord care according to institutional practice. Newborns assigned to the natural dry cord care group will receive dry cord care without topical antiseptics while maintaining routine hygienic care.
The primary outcome is the incidence of umbilical cord infection. Secondary outcomes include umbilical cord separation time,bacterial colonization assessed using bacterial cultures, and healthcare resource utilization for umbilical cord care, including nursing time, frequency of cord care, cord care materials, and associated costs.Umbilical cord status and clinical signs of infection will be assessed daily during hospitalization. After discharge, caregivers will continue follow-up assessments by submitting standardized photographs of the umbilical cord to a secure study-specific LINE group until one day after cord separation.
This study is expected to provide high-quality clinical evidence regarding the effectiveness, safety, and healthcare resource utilization associated with natural dry cord care compared with routine alcohol cord care and may contribute to future evidence-based neonatal cord care recommendations.
Вмешательства
- Другое Routine Alcohol Cord Care
Routine alcohol-based umbilical cord care performed according to institutional standard practice. - Другое Natural Dry Cord Care
Natural dry cord care without topical antiseptics while maintaining routine hygienic care.
Первичные конечные точки
- Incidence of Umbilical Cord Infection [Срок оценки: From birth through one day after umbilical cord separation]
Вторичные конечные точки (3)
- Umbilical Cord Separation Time [Срок оценки: From birth until umbilical cord separation]
- Bacterial Colonization [Срок оценки: At birth before the first cord care and on Day 3 after birth]
- Healthcare Resource Utilization for Umbilical Cord Care [Срок оценки: From birth through hospital discharge, typically 3-4 days after birth]
Критерии участия
Критерии включения
- Healthy neonates with a gestational age of 35 weeks or greater.
- Birth weight of 2,300 g or greater.
- Normal umbilical cord appearance at birth, with no evidence of trauma, infection, or congenital abnormalities of the umbilical cord.
Критерии исключения
- Neonates born to mothers with intrapartum fever (≥38°C), clinical chorioamnionitis, or rupture of membranes for more than 18 hours
- Meconium-stained amniotic fluid.
- Neonates admitted directly to the Newborn Care Center (NBC) or Pediatric Intensive Care Unit (PICU) after birth.
- Neonates from multiple gestations.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Профилактика
Центры проведения
Тайвань · 1 центр
- New Taipei Municipal TuCheng Hospital — New Taipei City
Публикации
- Imdad A, Bautista RM, Senen KA, Uy ME, Mantaring JB 3rd, Bhutta ZA. Umbilical cord antiseptics for preventing sepsis and death among newborns. Cochrane Database Syst Rev. 2013 May 31;2013(5):CD008635. doi: 10.1002/14651858.CD008635.pub2. PMID 23728678
- WHO recommendations on maternal and newborn care for a positive postnatal experience [Internet]. Geneva: World Health Organization; 2022. Available from http://www.ncbi.nlm.nih.gov/books/NBK579657/ PMID 35467813
Идентификаторы
NCT: NCT07728058 · 202600253A3