Early versus Conventional discontinuation of Caffeine therapy for Apnea of Prematurity- A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- The proportion of neonates with the recurrence of apnea after stopping caffeine therapy in both groups will be compared
研究概览
简要总结
Apnea of prematurity (AOP) is a common developmental comorbidity of preterm neonates with its incidence increasing with decreasing gestation. Apnea is defined as cessation of breathing for 20 seconds or longer or a shorter pause accompanied by bradycardia (<100 beats per minute), cyanosis, or pallor. On the basis of respiratory effort and airflow, apnea may be classified as central (cessation of breathing effort), obstructive (airflow obstruction usually at the pharyngeal level), or mixed. The majority of apneic episodes in preterm infants are mixed events, in which obstructed airflow results in a central apneic pause, or vice versa. The commonly used interventions to decrease the frequency and duration of apnea are continuous positive airway pressure and methylxanthine therapy.
The indications for starting caffeine in preterm neonates include treatment of apnea, prophylaxis for apnea and peri-extubation. The use of caffeine is associated with certain adverse effects such as tachycardia, emesis, jitteriness, increased oxygen consumption, energy expenditure and reduced weight gain. Although there is substantial evidence for initiation of caffeine therapy, there is no standard protocol for discontinuation of caffeine therapy and studies are sparse to address this issue. As a general recommendation, most of the neonatal unit continue caffeine till 33 to 34 weeks of gestation when the risk of apnea is low, whereas others stop early, as soon as infants attain a 7-day apnea-free period. The indication and evidence for starting caffeine therapy in preterm neonates is well defined in the literature, however, the time for cessation of caffeine therapy has been consensus-based on the clinician’s decision.
We planned a study to compare the occurrence of apnea in neonates where caffeine will be stopped once the neonate is apnea free and off respiratory support for 5 days and attains the post-menstrual age (PMA) of 33 weeks, with neonates where caffeine will be stopped at 34 weeks of gestation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 7.00 Day(s) 至 49.00 Day(s)（—）
- 性别
- All
入选标准
- •All preterm infants (both inborn and outborn) with gestational age 26 to 32 weeks and on caffeine therapy for apnea of prematurity fulfilling all the criteria below a)Neonate with birth weight ≤1250gm or ≤ 30 weeks gestational age or Neonate with 30-32weeks gestational age and on Respiratory support receiving caffeine b)Babies whose parents have given informed consent.
排除标准
- •Any one of the following a)Expired before eligibility b)Those with major congenital anomalies (antenatally diagnosed or visible at birth) c)Grade III or IV intraventricular haemorrhage d)Newborn who has not been weaned off respiratory support till 32+2weeks of Post Menstrual Age (PMA).
结局指标
主要结局
The proportion of neonates with the recurrence of apnea after stopping caffeine therapy in both groups will be compared
时间窗: Death or discharge
次要结局
- The following clinical outcomes will be compared in both the groups after stoppage of caffeine therapy:(1. Median day of occurrence of apnea after stopping caffeine)
研究者
Nirupa Chandorkar
National Institute of Medical Science and Research, Jaipur, Rajasthan