Community Based Management of Fast Breathing in Infants Aged < 60 Days: A Double-Blind, Randomized Placebo-Controlled Trial in Low-income Settlements of Karachi
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 963
- 试验地点
- 1
- 主要终点
- Treatment failure
研究概览
简要总结
The aim of the study is to determine optimal management of isolated fast breathing in young infants in a trial design conducted in primary care settings.
The investigators hypothesized that proportion of infants who fail therapy will be 4% in each group. A 6% or less difference in failure rate will be considered equivalent.
详细描述
The management of isolated fast breathing is therefore unknown and our experience suggests that these infants could perhaps be managed without antibiotics. Widespread application of the WHO clinical algorithm could therefore result in the referral of as many as 13.7% (135.7 per 1000 live births) of all infants for isolated fast breathing, the vast majority of these unnecessarily, and exposing infants to a high risk of nosocomial sepsis and hospital mortality in addition to over-burdening health resources.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 59 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Preterm infants (born <37 weeks)
- •Presence of audible murmur
- •Any concurrent signs of severe infection:
- •not feeding well
- •movement only when stimulated
- •severe chest in-drawing
- •axillary temperature ≥38.0oC or ≤35.5oC
- •Any sign of being critically ill (Cyanosis, bulging fontanel, unable to feed, unable to cry, apnoea, convulsions, unconscious, persistent vomiting)
- •Weight <1800gm at the time of presentation
- •Major congenital malformations or suspected chromosomal abnormalities
- •Hospitalization for illness in the last two weeks
- •Previous inclusion in the study
研究组 & 干预措施
Amoxicillin
This is an active intervention
干预措施: Amoxicillin (Drug)
Sugar Syrup
干预措施: Sugar Syrup (Drug)
结局指标
主要结局
Treatment failure
时间窗: Day 8 of enrollemnt
1. O2 sat \<90% on Day 2 or any time until Day 7. 2. Clinical deterioration: emergence of any sign of being critically ill or severe infection at any time after randomization (as defined in exclusion criteria) 3. Development of serious adverse effect of the study antibiotics (death, organ failure, anaphylactic reaction, severe diarrhoea, disseminated and severe rash). 4. Hospitalization any time after admission in the study. 5. Death anytime within day 1-7 of enrolment
次要结局
- Compliance to treatment(80% of total dosage)
- Proportion of infants relapse(No treatment failure by day 8 and signs of sepsis or fast breathing between day 8-14)
研究者
Shiyam Sunder Tikmani
Research Supervisor
Aga Khan University