Caffeine Citrate for the Treatment of Apnea Associated With Bronchiolitis in Young Infants: A Randomized, Double Blind, Controlled Trial (RCT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The primary efficacy outcome in this double-blinded study was the time until last apnea episode in both groups.
研究概览
简要总结
Viral bronchiolitis is the most common lower respiratory tract infection of infancy. Apnea is a complication of bronchiolitis, reported in 16 - 21% of cases. Caffeine, a trimethylxanthine, acts as an antagonist to endogenous adenosine and a potent central nervous system stimulant. In apnea of prematurity, caffeine is believed to work by increasing central respiratory drive.
Infants ≤4 months of age, presenting to pediatric emergency center Al-Sadd, from September 2011 to May 2014, with a diagnosis of viral bronchiolitis associated with apnea.
A randomized, double-blind, controlled trial with a sample size of 45 patients per group
Data Collection methods, instruments used measurements:
Randomization:
In the emergency department, the patients will be assigned to either one of the two treatments using a computer-generated randomized numbers in a 1:1 ratio. Pharmacy will prepare sequential sealed vials containing the experimental drugs. Randomization code will be revealed only after all patients completed the study. The medical team in addition to the patients will be blinded to the medication delivered. There will be no detectable difference in the color, smell of the two study treatments.
Guardians or parents of eligible infants will be approached regarding the study, explaining the purpose and the treatment modalities. Patients will be included after obtaining a verbal and written consent.
Study Intervention:
Treatment 1: Single stat dose (25 mg per kilogram of body weight) of intravenous caffeine citrate (25mg caffeine citrate equal to 12.5mg caffeine base).
Treatment 2: Placebo with an equivalent volume of normal saline. Calculated study medications will be diluted with Dextrose 5% in Water to 20 ml and will be given intravenous over 30 minutes using syringe infusion pump.
After random assignment, eligible infants will receive one of the study treatments. Non-pharmacological therapies may be used as necessary to control apnea. Antibiotics and antipyretics may be used as per the discretion of the treating physician.
After stabilization of patients as usually done in Pediatric Emergency Center , patients will be admitted to pediatric intensive care unit (PICU) for further monitoring monitoring when indicated.
详细描述
Study area/setting:
Pediatric emergency center Al-Sadd, (PEC) is the main pediatric emergency centre in the state of Qatar with approximately 200,000 visits annually. It has a capacity of 42 observation beds providing most of the inpatient facilities except for intensive care monitoring. Patients admitted to the Pediatric Emergency Center are managed there until discharged home unless an Intensive Care Unit admission is required.
Study Subjects:
-
Inclusion criteria: Infants ≤4 months of age, presenting to pediatric emergency center Al-Sadd, from September 2011 to May 2014, with a diagnosis of viral bronchiolitis associated with apnea.
-
Exclusion criteria:
-
Hypersensitivity to caffeine.
-
Patients on caffeine treatment.
-
Cardiovascular congenital abnormalities.
-
Infants with a previous diagnosis of gastroesophageal reflux disease.
-
Hypoglycemia and/or electrolytes disorders.
-
Suspected sepsis.
-
Seizure disorders.
-
Inborn errors of metabolism.
-
Renal and/or hepatic impairment.
-
Major congenital anomalies of the upper and lower respiratory tract (severe tracheomalacia, trachea-esophageal fistula, diaphragmatic hernia, congenital lobar emphysema, congenital cystic adenomatoid malformation).
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Day 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants ≤4 months of age, presenting to pediatric emergency center Al-Sadd, from September 2011 to May 2014, with a diagnosis of viral bronchiolitis associated with apnea.
排除标准
- •Hypersensitivity to caffeine.
- •Patients on caffeine treatment.
- •Cardiovascular congenital abnormalities.
- •Infants with a previous diagnosis of gastroesophageal reflux disease.
- •Hypoglycemia and/or electrolytes disorders.
- •Suspected sepsis.
- •Seizure disorders.
- •Inborn errors of metabolism.
- •Renal and/or hepatic impairment.
- •Major congenital anomalies of the upper and lower respiratory tract (severe tracheomalacia, trachea-esophageal fistula, diaphragmatic hernia, congenital lobar emphysema, congenital cystic adenomatoid malformation).
研究组 & 干预措施
caffeine Citrate
干预措施: Caffeine citrate (Drug)
Normal saline
干预措施: Normal saline (Drug)
结局指标
主要结局
The primary efficacy outcome in this double-blinded study was the time until last apnea episode in both groups.
时间窗: 2 year 8 mongths
次要结局
- The overall length of hospital stay in both groups.(2 year 8 months)
- The proportion of patients with apnea resolution at 12 hours in both groups,(2 year and 8 months)
- The length of oxygen therapy needed in both groups.(2 year 8 months)
- The frequency of apnea in the first 24, 48 and 72 hours after medication administration for both arms(2 year and 8 months)
- The duration of apnea in the first 24, 48, and 72 hours after medication administration for both arms(2 year and 8 months)
- Invasive and non-invasive respiratory support needed in both groups.(2 year 8 months)
- The time until feeding was tolerated in both groups.(2 year 8 months)
- Spot heart rate in both groups was compared every 4 hours from enrollment for up to three days.(2 year 8 months)
- The length of PICU/step-down unit stay in both groups.(2 year 8 months)