CO2 Inhalation as a New Treatment Modality for Apnea of Prematurity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- The decrease in total apnea time (duration of all apneic pauses ≥ 5 seconds) during administration of theophylline and carbon dioxide.
研究概览
简要总结
The objective of the present proposed study is to discover whether, in the nursery setting, administration of low concentration inhaled CO2 (0.8%) for a prolonged period (3 days) can make breathing more regular with less apneic time than that observed with administration of theophylline. The hypothesis to be tested is that inhalation of low concentration CO2 (0.8%) will reduce apnea more effectively and will have fewer adverse side effects than theophylline.
详细描述
- To discover whether, in the nursery setting, continuous administration of a low concentration of inhaled CO2 (0.8%) for a prolonged period (3 days) can make breathing in preterm infants more regular with less apneic time than that observed with theophylline.
- To discover whether inhalation of low CO2 decreases apneas, particularly prolonged apneas (>20 seconds), more effectively than theophylline.
- To discover whether short term (during hospitalization) and long term (2 years) adverse side effects are less pronounced with CO2 than with theophylline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 27 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants between 27 and 32 weeks gestational age hospitalized in the neonatal intensive or intermediate care units
- •Significant apnea, defined as 5 or more self-resolved apneas, or 2 or more apneas requiring intervention over a 12 hr period
排除标准
- •Already on methylxanthine treatment
- •On supplemental oxygen, nasal continuous positive airway pressure (CPAP)
- •Had major congenital anomalies, sepsis, or other known causes of apnea
研究组 & 干预措施
Theophylline
Oral loading dose of 6 mg per kilogram of body weight of theophylline followed by a maintenance dose of 2 mg per kilogram every 8 hours plus room air by nasal prongs at 0.5 l/min for 3 days.
干预措施: Theophylline (Drug)
CO2 inhalation
Equivalent loading and maintenance volume of oral normal saline plus CO2 (3% at the source, approximately 1% inhaled) with room air by nasal prongs at 0.5 l/min for 3 days
干预措施: CO2 inhalation (Other)
结局指标
主要结局
The decrease in total apnea time (duration of all apneic pauses ≥ 5 seconds) during administration of theophylline and carbon dioxide.
时间窗: 3 days
次要结局
- Decrease in the rate of long apneas (≥ 20 seconds) and the incidence of short term side effects(3 days)