Can Betamethasone Given After Birth Help Extremely Premature Babies Come Off Breathing Support Safely and Effectively?
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: Betamethasone.
- Кому может быть актуально
- Состояния в реестре: Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD). Базовые параметры: до 28 Weeks · 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
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Efficacy and Safety of Postnatal Betamethasone for Respiratory Weaning in Extremely Low Gestational Age Neonates (ELGANs) in a Prospective Cohort - Proof of Concept Pilot Study
Обзор
The goal of this study is to determine if giving a steroid medication (specifically, betamethasone) after birth can help extremely premature babies (born before 28 weeks) come off breathing machines safely and reduce their risk of chronic lung disease associated with prematurity. Only babies who meet treatment criteria will receive this medication. Babies who do not meet treatment criteria will not receive medication. The main questions it aims to answer are: * Does betamethasone make it easier for babies to come off a breathing machine? * Does betamethasone cause any harmful side effects on growth or development? All babies in this study will: * Receive standard NICU care, with or without betamethasone * Have their progress, growth, and development followed over time
Подробное описание
Babies born extremely early (before 28 weeks of pregnancy) often have very immature lungs and usually need a breathing machine to stay alive. Many of these babies develop a chronic lung disease associated with prematurity called bronchopulmonary dysplasia, which can cause breathing problems that may last for months or years.
Doctors sometimes use steroid medications after birth to help reduce lung inflammation, make breathing easier, and help babies come off the ventilator sooner. One of these medications is betamethasone. Betamethasone is already commonly given to mothers before preterm birth to help babies' lungs mature.
At our hospital, betamethasone has been given after birth for more than 20 years to help some premature babies breathe better and come off a breathing machine. This study will help us learn how well this medicine works and possible side effects.
All babies born before 28 weeks gestation will be approached for enrollment in this study. Babies with lung disease severe enough according to predetermined criteria will receive betamethasone. Babies who dont have severe lung disease will not receive betamethasone.
Вмешательства
- Препарат Betamethasone
Infants who meet clinical criteria will receive a 5-day course of postnatal betamethasone: 0.125 mg/kg/dose IM every 24 hours for 3 days then 0.0625 mg/kg/dose IM every 24 hours for 2 days
Первичные конечные точки
- The rate of successful respiratory weaning [Срок оценки: From initiation of treatment until 7 days after treatment completion]
Вторичные конечные точки (10)
- The incidence of adverse events [Срок оценки: During betamethasone administration period (5 days)]
- The incidence of adverse events [Срок оценки: From the time of initiation of betamethasone until the time of NICU discharge or 52 weeks of age, whichever comes first]
- The incidence of adverse events [Срок оценки: During betamethasone administration period and up to 72 hours after completion of betamethasone administration]
- The incidence of adverse events [Срок оценки: From the time of initiation of betamethasone until the time of NICU discharge or 52 weeks of age, whichever comes first]
- The incidence of mortbidities associated with extreme prematurity [Срок оценки: From admission until the time of NICU discharge or 52 weeks of age, whichever comes first]
- Anthropometric measurements [Срок оценки: From discharge to 24 months corrected age]
- Anthropometric measurements [Срок оценки: From discharge to 24 months corrected age]
- Anthropometric measurements [Срок оценки: From discharge to 24 months corrected age]
- Neurodevelopmental outcomes [Срок оценки: at 24 months corrected age]
- Bronchopulmonary dysplasia diagnosis [Срок оценки: at 36 weeks corrected age]
Критерии участия
Критерии включения
- Infants born at less than 28 weeks gestation age
- Admitted to WMC NICU prior to day of life 35
Критерии исключения
- Infants with major congenital or chromosomal abnormalities.
- Death prior to DOL 8.
- Previous exposure to postnatal steroids
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Maria Fareri Children's Hospital at Westchester Medical Center — Valhalla
Публикации
- DeCastro M, El-Khoury N, Parton L, Ballabh P, LaGamma EF. Postnatal betamethasone vs dexamethasone in premature infants with bronchopulmonary dysplasia: a pilot study. J Perinatol. 2009 Apr;29(4):297-304. doi: 10.1038/jp.2008.194. Epub 2008 Dec 4. PMID 19052552
Идентификаторы
NCT: NCT07447739 · 28646