Improving Care For Infants With Laryngomalacia: A Pilot Randomized Controlled Trial of Omeprazole Versus Placebo
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Laryngomalacia Symptom Score
研究概览
简要总结
Noisy breathing is commonly caused by a floppy voicebox which is a condition called laryngomalacia. The cause of laryngomalacia is not fully understood, but some studies have suggested that it could be due to acid escaping from the stomach and spreading up the swallowing passage to the throat (acid reflux). This affects about 1 in 100 newborns and is therefore one of the most common reasons for infants to see Otolaryngologists at BC Children's Hospital (BCCH). These infants can have a spectrum of distressing symptoms including squeaky breathing, choking, difficulty feeding, failure to gain weight, and episodes of turning blue (due to lack of oxygen).
At present, Otolaryngologists at BCCH will sometimes give children with laryngomalacia medication to reduce the amount of acid they make in their stomachs, in the hope that this will reduce their symptoms of laryngomalacia. It has never been scientifically confirmed whether anti-reflux medication will benefit these children any more than doing nothing at all.
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
- — 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children less than 1 years old
- •children determined that they have laryngomalacia at the Pediatric Otolaryngology clinic at BC Children's Hospital.
排除标准
- •Children cannot participate in this study if they have:
- •those already on anti-reflux medicine and considered medically unsafe to go through the washout period;
- •allergy to the trial medications;
- •nasogastric or permanent feeding tube;
- •other laryngeal abnormalities.
研究组 & 干预措施
Placebo
Two different placebo formulations will be created which will designed to be identical in appearance, taste, and consistency to the two study medications.
干预措施: Placebo (Drug)
Omeprazole
Omeprazole (a proton-pump inhibitor) is the most common treatment given to infants with laryngomalacia, in the hope that this will reduce their symptoms. Although this is an effective anti-reflux medication in this population, its use is off-label, and like any medication has potential risks, particularly in very young children. 2 mg/kg/day omeprazole.
干预措施: Omeprazole (Drug)
结局指标
主要结局
Laryngomalacia Symptom Score
时间窗: Change from baseline and at end of study (baseline and 8 weeks)
This score is a disease-specific quality of life measure for laryngomalacia. Each of the symptoms that can occur in laryngomalacia are scored as present (1) or absent (0) as follows - inspiratory stridor, suprasternal retraction, substernal retraction, feeding difficulty, choking, post-feeding vomit, failure to thrive (i.e. poor weight gain with deviation from the normal growth curve), and cyanosis. Therefore for each patient, a total symptom score is calculated (8 = all symptoms, 0 = no symptoms).
次要结局
- End of treatment 24-hour double-probe pH monitoring(Change from baseline and at end of study (baseline and 8 weeks))
- Revised Infant Gastro-Esophageal Reflux Questionnaire(Change from baseline and at end of study (baseline and 8 weeks))
- Caring For a Child with Laryngomalacia Family Impact Questionnaire(Change from baseline and at end of study (baseline and 8 weeks))
- Reflux Finding Score(Change from baseline and at end of study (baseline and 8 weeks))
- Weight(Change from baseline, to half-way point and at end of study (baseline, 4 weeks and 8 weeks))
研究者
Neil Chadha
Clinical Assistant Professor
Children's & Women's Health Centre of British Columbia