The Caffeine Therapy in the Fetal to Neonatal Transition in Preterms
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Necessity of intubation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 2 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature newborns with birth weight less than 1250 grams
- •Who are not intubated in the delivery room
排除标准
- •Premature newborns from other hospitals
- •Presence of a major congenital malformation or genetic syndrome
研究组 & 干预措施
Early Caffeine Group
Group administering caffeine in the first 2 hours of life. Patients in the early caffeine group will receive an attack dose of caffeine 20 mg/kg and begin maintenance dose 10 mg/kg/day.
干预措施: Early Caffeine administration (Drug)
Control Group
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.
干预措施: Control Group (Other)
结局指标
主要结局
Necessity of intubation
时间窗: first week of life
Noninvasive ventilation failure will be defined as intubation in the first seven days of life with the need for invasive ventilation for at least 24 hours.
次要结局
- Number of Participants with Intracranial hemorrhage(followed up at least until 36 weeks of corrected age, discharge or death.)
- mechanical ventilation time(until first successful extubation (followed up at least until 36 weeks of corrected age, discharge or death))
- Number of Participants with Bronchopulmonary dysplasia(followed up at least until 36 weeks of corrected age, discharge or death.)
- Number of Participants with Retinopathy of prematurity(followed up at least until 36 weeks of corrected age, discharge or death.)
研究者
Gabriela Scholer Trindade
Doctor
Hospital de Clinicas de Porto Alegre