Treatment of High-Risk Moderate Acute Malnutrition Using Expanded Admission Criteria (Hi-MAM Study): A Cluster-randomized Controlled Trial Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,322
- 试验地点
- 1
- 主要终点
- Recovery from moderate acute malnutrition (MAM)
研究概览
简要总结
This project explores whether children have better growth and cognitive development when the clinic identifies "higher risk" MAM children and support them either with the same treatment as SAM children or with the recommended practice: nutrition counseling.
详细描述
This is a cluster-randomized controlled trial taking place in 20 community clinics providing malnutrition care in Sierra Leone.
All participants will be children aged 6-59 months. Control participants will have moderate acute malnutrition (MAM), defined as mid-upper arm circumference (MUAC) 11.5-<12.5. High Risk MAM will be defined with a MUAC 11.5 to <11.9 or WAZ<-3.5 or Mother not the caretaker or not breastfeeding at <2 years old. Low risk MAM defined with a MUAC 11.9 to <12.5 with no risk factors.
Control group and low risk group caregiver's will received nutrition education via mother care groups every two weeks for 6 weeks and will be followed up 12 and 24 weeks post-enrollment.
High risk group will receive 1 week supply of amoxicillin at enrollment and 1 sachet of RUTF per day till MUAC is equal to or greater than 12.5 or up to 12 weeks of treatment. Their caregiver will also receive nutrition education via the mother care groups. The investigators will also follow up with the participant at 12 and 24 weeks post-enrollment.
A subset of the participants in each group will also be enrolled in a cognitive development substudy were the investigators will be using a eye tracking performance assessment. Investigators will also enroll health adult participants for eye tracking assessment. Adult data will be used as a reference when interpreting results.
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
- None
入排标准
- 年龄范围
- 6 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •uncomplicated MAM (based on MUAC equal to or greater than 11.5 cm and <12.5)
排除标准
- •currently involved in another research trial or feeding program
- •medical complication such as oedema, severe nausea/vomiting, severe dehydration, or severe pneumonia
- •have a diagnosed or visible sign of developmental delay
- •have a history of peanut or milk allergy
研究组 & 干预措施
Moderate Acute Malnutrition (MAM)
MAM children at control clinics or MAM children at intervention clinics that do no have high rick characteristics. Control treatment is "Mother Care" counselling, delivered by a respected elder in the local community.
干预措施: Mother Care group (Behavioral)
High Risk Moderate Acute Malnutrition (MAM)
The intervention treatment incorporates Mother Care counselling, provision of one packet (508 calories) of ready-to-use therapeutic food (RUTF) daily and a 1 week course of amoxicillin. This provision will continue until the child has reached a mid-upper arm circumference (MUAC) equal to or greater than 12.5 cm or 12 weeks have elapsed.
干预措施: amoxicillin (Drug)
High Risk Moderate Acute Malnutrition (MAM)
The intervention treatment incorporates Mother Care counselling, provision of one packet (508 calories) of ready-to-use therapeutic food (RUTF) daily and a 1 week course of amoxicillin. This provision will continue until the child has reached a mid-upper arm circumference (MUAC) equal to or greater than 12.5 cm or 12 weeks have elapsed.
干预措施: Ready-to-use therapeutic food (RUTF) (Dietary Supplement)
High Risk Moderate Acute Malnutrition (MAM)
The intervention treatment incorporates Mother Care counselling, provision of one packet (508 calories) of ready-to-use therapeutic food (RUTF) daily and a 1 week course of amoxicillin. This provision will continue until the child has reached a mid-upper arm circumference (MUAC) equal to or greater than 12.5 cm or 12 weeks have elapsed.
干预措施: Mother Care group (Behavioral)
结局指标
主要结局
Recovery from moderate acute malnutrition (MAM)
时间窗: up to 12 weeks of treatment
proportion of participants recovered based on mid-upper arm circumference(MUAC) Recovery is defined as MUAC greater than or equal to 12.5cm before or at 12 weeks after enrollment.
次要结局
- Participants that remain or become Stunted(24 weeks post-enrollment)
- Participants deterioration to severe acute malnutrition(SAM)(Duration of the study 24 weeks post-enrollment)
- Eye tracking performance for cognitive development(24 weeks post enrollment)
- Participant survival rates(Duration of the study 24 weeks post-enrollment)
- Participants that remain or become underweight using weight for age z-score(24 weeks post-enrollment)
- Participants that remain or become Wasted(24 weeks post-enrollment)