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

Malnutrition Clinical Trial

— Hi-MAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03647150
• Other study ID #: 201807153
• Status: Completed
• Phase: N/A
• Start date: November 13, 2018
• Est. completion date: June 5, 2020

Study information

• Verified date: August 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1322
• Est. completion date: June 5, 2020
• Est. primary completion date: June 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 59 Months

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition

Intervention

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

Locations

Country	Name	City	State
Sierra Leone	Project Peanut Butter	Freetown

Sponsors (4)

Lead Sponsor	Collaborator
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

Country where clinical trial is conducted

Sierra Leone, 

References & Publications (7)

Chang CY, Trehan I, Wang RJ, Thakwalakwa C, Maleta K, Deitchler M, Manary MJ. Children successfully treated for moderate acute malnutrition remain at risk for malnutrition and death in the subsequent year after recovery. J Nutr. 2013 Feb;143(2):215-20. doi: 10.3945/jn.112.168047. Epub 2012 Dec 19. — View Citation

Ekelund U, Ong KK, Linné Y, Neovius M, Brage S, Dunger DB, Wareham NJ, Rössner S. Association of weight gain in infancy and early childhood with metabolic risk in young adults. J Clin Endocrinol Metab. 2007 Jan;92(1):98-103. Epub 2006 Oct 10. — View Citation

Joshua GE, Jadhav M, Bhaktaviziam A, Mokashi S. Mental retardation in children. II. Leucodystrophies. Indian Pediatr. 1974 Jan;11(1):53-9. — View Citation

Khara T, Mwangome M, Ngari M, Dolan C. Children concurrently wasted and stunted: A meta-analysis of prevalence data of children 6-59 months from 84 countries. Matern Child Nutr. 2018 Apr;14(2):e12516. doi: 10.1111/mcn.12516. Epub 2017 Sep 25. — View Citation

Lenters LM, Wazny K, Webb P, Ahmed T, Bhutta ZA. Treatment of severe and moderate acute malnutrition in low- and middle-income settings: a systematic review, meta-analysis and Delphi process. BMC Public Health. 2013;13 Suppl 3:S23. doi: 10.1186/1471-2458-13-S3-S23. Epub 2013 Sep 17. Review. — View Citation

Maust A, Koroma AS, Abla C, Molokwu N, Ryan KN, Singh L, Manary MJ. Severe and Moderate Acute Malnutrition Can Be Successfully Managed with an Integrated Protocol in Sierra Leone. J Nutr. 2015 Nov;145(11):2604-9. doi: 10.3945/jn.115.214957. Epub 2015 Sep 30. — View Citation

Schofield C, Ashworth A. Why have mortality rates for severe malnutrition remained so high? Bull World Health Organ. 1996;74(2):223-9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery from moderate acute malnutrition (MAM)	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.	up to 12 weeks of treatment
Secondary	Participant survival rates	Proportion of participants survival rates during the study	Duration of the study 24 weeks post-enrollment
Secondary	Participants deterioration to severe acute malnutrition(SAM)	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.	Duration of the study 24 weeks post-enrollment
Secondary	Participants that remain or become underweight using weight for age z-score	the difference between the weight for age z-score(WAZ) from enrollment to 24 weeks post-enrollment	24 weeks post-enrollment
Secondary	Participants that remain or become Stunted	the difference between length for age z-score(LAZ) from enrollment to 24 weeks post enrollment	24 weeks post-enrollment
Secondary	Participants that remain or become Wasted	the difference between weight for length z-score(WHL) from enrollment to 24 weeks post enrollment	24 weeks post-enrollment
Secondary	Eye tracking performance for cognitive development	the difference between the eye tracking performance from enrollment to 24 weeks post enrollment	24 weeks post enrollment

External Links

•   United Nations Department of Economic and Social Affairs, P.D. World Population Prospectus 2017. 2017
•   WHO. IMCI chart booklet. 2014