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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03647150
Recruitment Status : Completed
First Posted : August 27, 2018
Last Update Posted : September 1, 2020
Sponsor:
Collaborators:
Centre for Global Child Health, Hospital for Sick Kids, Toronto, Canada
Department of Psychology, University of Tampere, Finland
Project Peanut Butter, Sierra Leone
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Malnutrition Drug: amoxicillin Dietary Supplement: Ready-to-use therapeutic food (RUTF) Behavioral: Mother Care group Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1322 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of High-Risk Moderate Acute Malnutrition Using Expanded Admission Criteria (Hi-MAM Study): A Cluster-randomized Controlled Trial Protocol
Actual Study Start Date : November 13, 2018
Actual Primary Completion Date : June 5, 2020
Actual Study Completion Date : June 5, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition
Drug Information available for: Amoxicillin

Arms and Interventions
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Arm Intervention/treatment
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.
 Behavioral: Mother Care group
Nutrition education via mother care groups lead by a respected elder in the local community
Experimental: 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.
 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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647150


Locations
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Sierra Leone
Project Peanut Butter
Freetown, Sierra Leone
Sponsors and Collaborators
Washington University School of Medicine
Centre for Global Child Health, Hospital for Sick Kids, Toronto, Canada
Department of Psychology, University of Tampere, Finland
Project Peanut Butter, Sierra Leone
Investigators
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Principal Investigator: Mark Manary, MD Washington University School of Medicine in St. Louis
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03647150    
Other Study ID Numbers: 201807153
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents