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Идёт набор NCT05454332

The Caffeine Therapy in the Fetal to Neonatal Transition

Фаза IV С лечением Mechanical Ventilation Complication Caffeine Ventilator Lung; Newborn

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: Early Caffeine administration, Control Group.
Кому может быть актуально
Состояния в реестре: Mechanical Ventilation Complication, Caffeine, Ventilator Lung; Newborn. Базовые параметры: до 2 Hours · 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
Бразилия
Следующий шаг
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Официальное название

The Caffeine Therapy in the Fetal to Neonatal Transition in Preterms

Обзор

Introduction: The caffeine is used in the treatment for apnea of prematurity and it has several positive effects in the neurodevelopment of preterm babies. There are innumerable observational studies suggesting that initiating caffeine in the first hours of life may offer more benefits in the reduction of the necessity of intubation and in ventilation time. It is necessary to expand further research on the best time to start caffeine, which may improve the quality of care for premature infants. Objective: To evaluate the benefits of caffeine administration in the first two hours of life compared to administration at 24 hours of life in premature patients on noninvasive mechanical ventilation with birth weights less than 1250 grams. Methodology: Preterm newborn patients with birth weight \< 1250 grams born at Hospital de Clínicas de Porto Alegre who are not intubated in the delivery room will be included. Patients will be randomized into two groups. One arm of the study will receive caffeine at 2 hours of age and the other arm will receive caffeine at 24 hours of age (control). Patients in the control group will receive 0.9% SF at 2 hours of life in order to keep the study blinded. The following outcomes will be evaluated: need for intubation, time on invasive and non-invasive mechanical ventilation, BPD, necrotizing enterocolitis, need for ROP treatment, PDA with hemodynamic repercussions, peri-intraventricular hemorrhage, leukomalacia and death. The sample size calculation is 50 patients, 25 in each arm. Expected Results: It is expected to find a 43% reduction in the need for intubation in preterm infants who receive caffeine in the first two hours of life compared to administration at 24 hours of life. It is also expected to find a reduction in mechanical ventilation time, in addition to a possible reduction in negative outcomes associated with prematurity.

Вмешательства

  • Препарат Early Caffeine administration
    Blinding will be done with the administration of saline solution. Patients in the early caffeine group will receive an attack dose of caffeine 20 mg/kg and begin maintenance dose 10 mg/kg/day. Patients in the late caffeine group, receive bolus of saline solution in the first 2 hours of life, starting, at 24 hours of life, the caffeine-loading dose 20 mg/kg and after maintenance dose 10mg/kg/day. The medical team will prescribe the medication, and the pharmacy will be responsible for randomly dis
  • Другое Control Group
    Blinding will be done with the administration of saline solution. Patients in the early caffeine group will receive an attack dose of caffeine 20 mg/kg and begin maintenance dose 10 mg/kg/day. Patients in the late caffeine group, receive bolus of saline solution in the first 2 hours of life, starting, at 24 hours of life, the caffeine-loading dose 20 mg/kg and after maintenance dose 10mg/kg/day. The medical team will prescribe the medication, and the pharmacy will be responsible for randomly dis

Первичные конечные точки

  • Necessity of intubation [Срок оценки: first week of life]
Вторичные конечные точки (4)
  • mechanical ventilation time [Срок оценки: until first successful extubation (followed up at least until 36 weeks of corrected age, discharge or death)]
  • Number of Participants with Bronchopulmonary dysplasia [Срок оценки: followed up at least until 36 weeks of corrected age, discharge or death.]
  • Number of Participants with Intracranial hemorrhage [Срок оценки: followed up at least until 36 weeks of corrected age, discharge or death.]
  • Number of Participants with Retinopathy of prematurity [Срок оценки: followed up at least until 36 weeks of corrected age, discharge or death.]

Критерии участия

Критерии включения

  • Premature newborns with birth weight less than 1250 grams
  • Who are not intubated in the delivery room

Критерии исключения

  • Premature newborns from other hospitals
  • Presence of a major congenital malformation or genetic syndrome

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Профилактика

Центры проведения

Бразилия · 1 центр
  • Hospital de Clínicas de Porto Alegre — Porto Alegre

Идентификаторы

NCT: NCT05454332 · 2021-0463

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗