NCT03647150

Treatment of High-Risk Moderate Acute Malnutrition Using Expanded Admission Criteria

Treatment of High-Risk Moderate Acute Malnutrition Using Expanded Admission Criteria (Hi-MAM Study): A Cluster-randomized Controlled Trial Protocol

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,322 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 6 Months – 59 Months
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Malnutrition

Interventions

Type	Name	Description
DRUG	amoxicillin	At enrollment the child will receive a 1 week course of amoxicillin
DIETARY_SUPPLEMENT	Ready-to-use therapeutic food (RUTF)	1 sachet RUTF per day (508 calories) till child MUAC is greater than 12.4 cm or 12 weeks have elapsed
BEHAVIORAL	Mother Care group	Nutrition education via mother care groups lead by a respected elder in the local community

Timeline

• Start date: 2018-11-13
• Primary completion: 2020-06-05
• Completion: 2020-06-05
• First posted: 2018-08-27
• Last updated: 2020-09-01

Locations

1 site across 1 country: Sierra Leone