Improving the Outcomes of Community-based Management of Acute Malnutrition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,087
- 试验地点
- 1
- 主要终点
- Inpatient mortality
研究概览
简要总结
Severe acute malnutrition (SAM) affects 16 million children at any one time and is responsible for the deaths of over 500,000 children under 5 years of age each year. Treatment for severe acute malnutrition is based on the Community-based Management of Acute Malnutrition (CMAM) model. The current methods used for detecting high risk children have not prevented 5% mortality observed in regions using this program. The purpose of the study is to provide evidence that objective methods for detecting high risk children can be used to optimize efficiency of Community-based Management of Acute Malnutrition (CMAM) treatment programs and thus improve child health outcomes.
详细描述
A prospective observational study in inpatient care within community-based management of acute malnutrition(CMAM) program run by the nongovernmental organization called Alliance for International Medical Action (ALIMA) within the University of Maiduguri Teaching Hospital, Maiduguri, Nigeria
The objectives of the study are to validate the BedsidePEWS scores as a measure of severity of illness in children who are treated as inpatients for severe acute malnutrition and to compare the BedsidePEWS scores with other risk factors associated for mortality and relapse of children with severe acute malnutrition. The design is a prospective observational study of 1000 children admitted as inpatients in a CMAM program in Maidaguri Teaching Hospital in Maidaguri, Nigeria. Data collection (estimated duration 4-5 months) involves vital signs, and risk factor assessment every 12 hours for duration of hospitalization. Blood test for hemoglobin and malaria will be done once upon admission. Outcomes will be measured every 12 hours and include mortality and/or escalation and de-escalation of care. Logistic regression with significance testing will be used to compare BedsidePEWS scores and risk factors between patients and among individual patients within the outcome categories. Exploratory sensitivity analyses will repeat the main logistic regression analyses to evaluate the performance of partial BedsidePEWS score in patients with missing data of 1-3 of the 7 components, by randomly removing 1-3 data elements from the score calculation from patients, and by removing systolic blood pressure from scoring.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 1 to 59 months
- •Diagnosed with severe acute malnutrition (criteria for severe acute malnutrition is <3Z Weight for Height Z score, and/or MUAC <115mm, and/or bilateral pitting oedema)
- •Meet the criteria for admission into inpatient care (failed appetite test, and/or medical conditions).
- •Study amendment for inclusion: children with and without severe acute malnutrition admitted to emergency pediatric unit (EPU)
排除标准
- •Children with congenital anomalies that interfere with feeding (ie. cleft lip and/or palate); previous enrolment in this study.
结局指标
主要结局
Inpatient mortality
时间窗: From admission to inpatient care until the the earlier of the date of discharge from inpatient care or ten weeks after enrolment
survival or death during inpatient care
次要结局
- Number of Children receiving inpatient care who required de-escalation of treatment(From admission to inpatient care until the the earlier of the date of discharge from inpatient care or ten weeks after enrolment)
- Number of Children receiving inpatient care who required escalation of treatment(From admission to inpatient care until the the earlier of the date of discharge from inpatient care or ten weeks after enrolment)
研究者
Christopher Parshuram
Principal Investigator
The Hospital for Sick Children