Treatment of High-Risk Moderate Acute Malnutrition Using Expanded Admission Criteria (Hi-MAM)

The Washington University

Status: Completed

Conditions: Malnutrition

Treatments: Behavioral: Mother Care group; Dietary Supplement: Ready-to-use therapeutic food (RUTF); Drug: amoxicillin

Study type: Interventional

Funder types: Other

Identifiers

NCT03647150

201807153

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,322 patients

Sex: All

Ages: 6 to 59 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• uncomplicated MAM (based on MUAC equal to or greater than 11.5 cm and <12.5)

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,322 participants in 2 patient groups

Moderate Acute Malnutrition (MAM)

Other group

Description:

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.

Treatment:

Behavioral: Mother Care group

High Risk Moderate Acute Malnutrition (MAM)

Experimental group

Description:

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.

Treatment:

Behavioral: Mother Care group

Dietary Supplement: Ready-to-use therapeutic food (RUTF)

Drug: amoxicillin