Pathophysiological Evidence Driven Management of GERD in Neonatal ICU Infants: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 369
- 试验地点
- 2
- 主要终点
- Achievement of primary outcome: Improvement or maintenance of oral feeding and/or absence of GERD symptoms (based on feeding method at inception)
研究概览
简要总结
The goal of this investigator-initiated, single-center, randomized controlled trial (RCT) is to compare the effects of four weeks of three therapies on clinical and mechanistic outcomes based on pH-Imp testing using a three-arm parallel design in NICU infants with objective GERD diagnosis. The three therapies being compared are natural maturation, proton pump inhibitor (PPI) use, and added rice (AR) formula use. The main goals are:
- to evaluate and compare the efficacy of the three commonly used treatment interventions used in the NICU for GERD in a randomized controlled manner with the primary endpoint of oral feeding success and absence of troublesome symptoms (as defined below).
- to characterize the mechanisms of primary end point (success or failure) using pH-Impedance metrics.
详细描述
In consented subjects, eligibility is determined after initial diagnostic 24-hour pH Impedance test. These subjects will be randomized to one of the 3 arms of the study (natural maturation, PPI, AR formula) for 4 weeks of treatment. A second 24-hour pH Impedance test will be done on therapy at 4 weeks or before discharge, whichever occurs first. Primary outcome will also be measured at 4 weeks or at discharge, whichever comes first.
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
- None
入排标准
- 年龄范围
- 1 Day 至 8 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NICU infants of any gestational age who are between 37 - 47 weeks postmenstrual age at inception of the study meeting the following requirements:
- •GERD diagnosis using pH-impedance criteria (Acid Reflux Index ≥ 3% plus at least one of the following: # GER events >70 / day, Symptom Associated Probability ≥ 95%, Discal Baseline Impedance < 900 Ω)
- •Full enteral feeds
- •No current GERD therapies
排除标准
- •Known lethal chromosomal abnormalities or complex congenital syndromes
- •Severe neurologic pathologies requiring neuroactive medications or neurosurgery
- •Positive airway pressure or oxygen flow > 4 LPM
- •Upper gastrointestinal malformations requiring surgery
研究组 & 干预措施
Proton Pump Inhibitor (PPI)
Omeprazole will be prescribed for 4 weeks using the dose of 1.5mg/kg/dose daily.
干预措施: Omeprazole (Drug)
Added Rice (AR) Formula
Added rice formula will be ordered as the infant diet for the 4-week treatment period.
干预措施: AR formula (Other)
Natural maturation
Allows for time for infant maturation without treatment.
结局指标
主要结局
Achievement of primary outcome: Improvement or maintenance of oral feeding and/or absence of GERD symptoms (based on feeding method at inception)
时间窗: At 4 weeks of therapy or discharge, whichever occurs first
Achievement of the primary outcome will be measured by treatment group to determine efficacy. For subjects on full oral feeds at inception, the primary outcome will be met if there is maintenance of oral feeds AND absence of associated GERD symptoms. For subjects receiving any tube feeding at inception, the primary outcome will be met if there is improvement in oral feeding (ratio of oral to tube feeds) OR absence of troublesome symptoms. The metric for measuring the absence of troublesome symptoms will be vomiting \<2 times/day or coughing \<18 times/day.
Decrease in symptom associated probability on treatment
时间窗: At time 2 study (4 weeks or prior to discharge, whichever is earliest)
Change in symptom associated probability from time one pH impedance study (prior to treatment) to time 2 pH impedance study (during treatment) will be compared among treatment groups.
Decrease in ARI on treatment
时间窗: At time 2 study (4 weeks or prior to discharge, whichever is earliest)
Change in acid reflux index from time one pH impedance study (prior to treatment) to time 2 pH impedance study (during treatment) will be compared among treatment groups.
Decreased frequency of GER events on treatment
时间窗: At time 2 study (4 weeks or prior to discharge, whichever is earliest)
Change in number of reflux events from time one pH impedance study (prior to treatment) to time 2 pH impedance study (during treatment) will be compared among treatment groups.
Improvement (Increase) in distal baseline impedance on treatment
时间窗: At time 2 study (4 weeks or prior to discharge, whichever is earliest)
Change in distal baseline impedance from time one pH impedance study (prior to treatment) to time 2 pH impedance study (during treatment) will be compared among treatment groups.
次要结局
未报告次要终点
研究者
Sudarshan Jadcherla
Principal Investigator, Innovative Feeding Disorders Research Program
Nationwide Children's Hospital