Study of Erythromycin in GER-Associated Apnea of the Newborn
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reflux Impedance events (both acidic and non-acidic) as recorded by Multichannel Intraluminal (MII) pH Impedance
研究概览
简要总结
To evaluate the relationship of reflux and apnea and to determine whether the administration of erythromycin improves the incidence of GER and GER-associated apnea, bradycardic and/or desaturation events in a prospective randomized controlled trial.
详细描述
A randomized placebo-controlled trial to determine whether erythromycin, a drug known to enhance gut motility, will improve the incidence of GER and GER-associated apnea, bradycardiac and/or hypoxic events. The investigators have two aims: 1) to examine the relationship between GER and apnea, bradycardia, and/or desaturation (ABD) events by simultaneously employing a unique computer algorithm developed at the University of Virginia to measure ABD events and an Multi-channel Intra-luminal Impedance (MII) pH monitoring to measure GER episodes. 2) In a randomized placebo-controlled trial, the investigators will study whether erythromycin decreases GER and GER-associated apnea, bradycardia and/or hypoxia in premature infants.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants admitted to neonatal intensive care unit who are <37 weeks at birth and >14 days of age, non-intubated, on full feeds for 3 days with one of the following:
- •Any apnea, bradycardia, or desaturation (ABD) event, or
- •Documented symptoms of reflux
排除标准
- •major central nervous system, gastrointestinal, or complex cardiac anomalies
研究组 & 干预措施
Erythromycin
50 mg/kg/day divided every 6 hours oral for 7 days
干预措施: Erythromycin (Drug)
Erythromycin
50 mg/kg/day divided every 6 hours oral for 7 days
干预措施: Multi-channel intra-luminal impedance (MII) pH monitoring (Device)
Placebo
Dextrose 5 Water (D5W) equal amount as experimental every 6 hours oral for 7 days
干预措施: Multi-channel intra-luminal impedance (MII) pH monitoring (Device)
Placebo
Dextrose 5 Water (D5W) equal amount as experimental every 6 hours oral for 7 days
干预措施: Placebo (D5W) (Drug)
结局指标
主要结局
Reflux Impedance events (both acidic and non-acidic) as recorded by Multichannel Intraluminal (MII) pH Impedance
时间窗: during day 6 to 7 of study treatment
次要结局
- ABD events per Physiologic Monitoring Database(during the entire 7 days of treatment)
- ABD events recorded by nursing(during the entire 7 days of treatment)
研究者
Faranek Davalian, MD
Neonatology Fellow
University of Virginia