Efficacy and Safety of a New Oral Rehydration Solution (Hipp ORS 200 Apple) in Children With Acute Gastroenteritis: Randomized, Double-Blind Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 147
- 试验地点
- 2
- 主要终点
- Number of Participants That Were Successfully Rehydrated
研究概览
简要总结
It is generally recommended that oral rehydration should be used as first-line therapy to treat or prevent dehydration in children with acute gastroenteritis (AGE). Refusal to drink regular Oral Rehydration Solution (ORS) interfere with compliance with the recommended treatment.
The objective of this study is to compare the tolerance, acceptance, efficacy and safety of a new ORS (Hipp ORS 200 Apple) of improved palatability with regular ORS recommended by ESPGHAN in children with acute gastroenteritis (AGE).
详细描述
It is generally recommended that oral rehydration should be used as first-line therapy to treat or prevent dehydration in children with acute gastroenteritis (AGE). Despite the proven efficacy of oral rehydration therapy it remains underused. The main reason for this is that an ORS neither reduces the frequency of bowel movements and fluid loss nor shortens the duration of illness, which decreases its acceptance. Moreover, unpalatability of regular ORS decrease its acceptance, especially in children with lower degrees of dehydration. Refusal to drink regular ORS interfere with compliance with the recommended treatment. Parents, but also health care professionals, demand safe, effective, inexpensive, but also well tolerated and accepted ORS for management of AGE.
Recently, a new ORS (Hipp ORS 200 Apple) with improved taste has been developed, and is now frequently employed for the management of AGE. The proposed study will be the first double-blind randomized trial of this ORS. It will evaluate clinically meaningful benefits to be derived by children and caregivers from its use. If positive, this new ORS may become a routine recommendation for children with AGE.
The objective of this study is to compare the tolerance, acceptance, efficacy and safety of a new ORS (Hipp ORS 200 Apple) with regular ORS recommended by ESPGHAN in children with AGE.
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
- 4 Months 至 48 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children age 4 to 48 months
- •diarrhoea defined as the passage of three or more loose or watery stools per day for >1 but <5 days
- •mild (3%) or moderate dehydration (3-9%) according to the World Health Organization criteria (Table 1)
- •informed consent signed by at least one parent / caregiver
排除标准
- •diarrhea for <1 or >5 days
- •severe dehydration (>9%)
- •recent history of diarrhea indicated either by parent/guardian or hospital case notes
- •underlying chronic gastrointestinal disease (i.e., celiac disease, cow's milk protein intolerance)
- •breastfeeding >50%
- •under nutrition (weight/height ratio below the fifth percentile)
- •systemic infections
- •immune defects or immunosuppressive treatment
结局指标
主要结局
Number of Participants That Were Successfully Rehydrated
时间窗: Proportion of successfully rehydrated at 24 hours
The following components are included in primary outcome: * resolution of signs of dehydration * adequate weight gain * production of urine output during the trial
次要结局
- ORS Intake in ml(24 hours)
- Vomiting(24 hours)
- Unscheduled Intravenous Therapy(24 hours)
- Weight Gain in Gram(24 hours)
- Duration of Diarrhea (Hrs)(7days)
- Return Visit to the Emergency Department(1 week)
- Hospitalization(1 week)
- Adverse Events(24 hours)
- ORS Intake at 4 h(4 hrs)