Mother Screening for Relapse Using Mid-upper Arm Circumference Among Children Recovered From Severe Acute Malnutrition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Time to detection of relapse
研究概览
简要总结
The investigators propose a pilot randomized controlled trial to train mothers to screen their children post-discharge for relapse based on MUAC criteria to facilitate timely identification and referral to care for children who have relapsed.
详细描述
While interventions prioritizing rapid weight gain have led to improved survival for children with severe acute malnutrition (SAM), prevention of relapse to SAM after recovery is essential to improve long-term outcomes for children beyond survival. Mothers have been successfully trained to screen for new-onset SAM in community-based settings and perform as well as community health workers for detecting SAM. Here, the investigators propose a pilot randomized controlled trial in which mothers will be trained to screen their children post-discharge for relapse based on MUAC criteria to facilitate timely identification and referral to care for children who have relapsed.
SPECIFIC AIM 1: Determine the feasibility of training mothers to screen for relapse among children recovering from SAM compared to standard of care for early detection of relapse and re-entry to care. The investigators hypothesize that relapse will be detected earlier in children whose mothers have been trained to screen for relapse compared to standard of care (no mother screening).
Specific Aim 1A: Determine the burden of post-discharge relapse among children recovered from an episode of SAM in Boromo, Burkina Faso. The investigators hypothesize that >25% of children who have recovered from SAM in the study facilities will relapse within a 6-month period following their discharge.
Specific Aim 1B: Determine the acceptability and feasibility of training mothers to screen for relapse after discharge among children recovered from SAM. the investigators hypothesize that mothers will find MUAC screening acceptable and that training them will be feasible, as demonstrated by time and costs for training, willingness to participate in training, and follow-up in the trial.
SPECIFIC AIM 2: Determine the accuracy of mother-based screening for relapse among children recovering from SAM compared to a gold standard anthropometrist. the investigators hypothesize that mother screening will have a sensitivity and specificity of > 80% for the detection of relapsed SAM (MUAC < 11.5 cm) compared to screening by a trained anthropometrist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Outcomes assessor and investigator will be masked to intervention. In regards to the intervention, participants and care providers won't be masked.
入排标准
- 年龄范围
- 6 Months 至 59 Months(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Caregiver's aged 18 years old or older or a legal guardian or a relative aged 18 or older
- •Child aged 6-59 months
- •Child has recovered from an episode of SAM per Burkinabè national guidelines (WHZ ≥
- •2 and/or MUAC ≥ 12.5 cm in the past month
- •Family is planning to stay in the study area for 6 months
- •Appropriate consent from the caregiver or guardian
排除标准
- •Caregiver age under 18 years old, or legal guardian or relatives under 18 years old
- •Child age < 6 months or > 59 months
- •Twins/multiple births and children with feeding issues
- •Did not recover from SAM in the past month
- •Family is planning to move out of the study area in the next 6 months
- •Caregiver or guardian refuses to provide consent
研究组 & 干预措施
Mother screening
In this arm, mothers / children dyads will be enrolled. Mothers will be trained to measure mid-upper arm circumference (MUAC) on their children weekly for 6 months. All other standard care will be provided.
干预措施: Mother education on how to perform MUAC assessment (Other)
standard of care
In this arm, mothers / children dyads will be enrolled. No study intervention will be performed. all other standard of care will be provided.
结局指标
主要结局
Time to detection of relapse
时间窗: 6 months
Time to relapse using a log-rank test with a term for randomized treatment assignment will be used. Relapse will be defined using the Burkina Faso guideline for detecting malnutrition (MUAC \< 11.5 cm and / or weight-for-height Z-scores WHZ \< -3 SD)
Time to Detection of Relapse
时间窗: 6 months
Time to relapse using a log-rank test with a term for randomized treatment assignment will be used. Relapse will be defined using the Burkina Faso guideline for detecting malnutrition (MUAC \< 11.5 cm and / or weight-for-height Z-scores WHZ \< -3 SD)
次要结局
- height-for-age Z-score (HAZ)(6 months)
- Weight for Height Z score (WHZ)(6 months)
- weight-for-age Z-score (WAZ)(6 months)
- Weight for Height Z Score (WHZ)(6 months)
- Weight-for-age Z-score (WAZ)(6 months)
- Height-for-age Z-score (HAZ)(6 months)
