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Completed

NCT Number: NCT03647150

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

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.

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Key information

Conditions

Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Project Peanut Butter

Freetown, Sierra Leone

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amoxicillin

Drug

At enrollment the child will receive a 1 week course of amoxicillin

Ready-to-use therapeutic food (RUTF)

Dietary Supplement

1 sachet RUTF per day (508 calories) till child MUAC is greater than 12.4 cm or 12 weeks have elapsed

Mother Care group

Behavioral

Nutrition education via mother care groups lead by a respected elder in the local community

Primary outcomes

  1. Recovery from moderate acute malnutrition (MAM)

    Time frame: 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.

Secondary outcomes

  1. Participant survival rates

    Time frame: Duration of the study 24 weeks post-enrollment

    Proportion of participants survival rates during the study

  2. Participants deterioration to severe acute malnutrition(SAM)

    Time frame: Duration of the study 24 weeks post-enrollment

    Proportion of participants that deteriorate from moderate acute malnutrition(MAM) to severe acute malnutrition(SAM). SAM is defined at mid-upper arm circumference(MUAC)<11.5 or presence of oedema.

  3. Participants that remain or become underweight using weight for age z-score

    Time frame: 24 weeks post-enrollment

    the difference between the weight for age z-score(WAZ) from enrollment to 24 weeks post-enrollment

  4. Participants that remain or become Stunted

    Time frame: 24 weeks post-enrollment

    the difference between length for age z-score(LAZ) from enrollment to 24 weeks post enrollment

  5. Participants that remain or become Wasted

    Time frame: 24 weeks post-enrollment

    the difference between weight for length z-score(WHL) from enrollment to 24 weeks post enrollment

  6. Eye tracking performance for cognitive development

    Time frame: 24 weeks post enrollment

    the difference between the eye tracking performance from enrollment to 24 weeks post enrollment

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Centre for Global Child Health, Hospital for Sick Kids, Toronto, Canada
  • Department of Psychology, University of Tampere, Finland
  • Project Peanut Butter, Sierra Leone

Registry information

Official study title

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

Acronym: Hi-MAM

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 27, 2018
Registry last updated
Sep 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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