The Role of Electroencephalography Evaluation in Caffeine Discontinuation Timing in Premature Infants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Assessment of apnea risk after discontinuation of caffeine therapy in preterm infants.
研究概览
简要总结
The aim of this observational study is to investigate whether functional maturation assessment by electroencephalography in preterm infants can provide reliable data for the safe discontinuation of caffeine therapy without recurrence of apnea.
In preterm infants receiving caffeine therapy, an assessment of maturation will be performed by EEG at the time when discontinuation of caffeine treatment is planned.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born before 28 weeks of gestation with a birth weight of 1250 grams or less, who received prophylactic caffeine therapy.
- •Infants with a birth weight greater than 1250 grams and a gestational age below 32 weeks, who required invasive mechanical ventilation and were started on prophylactic caffeine therapy.
- •Infants born at less than 37 weeks of gestation, admitted to the neonatal intensive care unit, and treated with caffeine for apnea of prematurity.
- •Infants whose parents or legal guardians provided informed consent.
排除标准
- •Infants who did not receive caffeine therapy,
- •Infants for whom an EEG could not be performed,
- •Infants with major congenital malformations such as neuromuscular disorders, central nervous system developmental abnormalities, thoracic malformations, or major cardiac anomalies,
- •Infants who were transferred to another facility within one week before or after discontinuation of caffeine therapy.
结局指标
主要结局
Assessment of apnea risk after discontinuation of caffeine therapy in preterm infants.
时间窗: From enrollment to the end of treatment at 4 weeks
Apnea of prematurity is defined as a sudden cessation of breathing lasting at least 20 seconds, or of shorter duration if accompanied by bradycardia, cyanosis, pallor, or marked hypotonia.
次要结局
未报告次要终点
研究者
Salih Çağrı Çakır
Associate professor
Uludag University