Improving the Outcomes of Community-based Management of Acute Malnutrition

NCT04582773 | Completed

• 1 other identifier: REB1000063224
• Study Type: observational
• Target: 1,087
• Locations: 1 country
• Sites: 1

Brief Summary

Severe acute malnutrition (SAM) affects 16 million children at any one time and is responsible for the deaths of over 500,000 children under 5 years of age each year. Treatment for severe acute malnutrition is based on the Community-based Management of Acute Malnutrition (CMAM) model. The current methods used for detecting high risk children have not prevented 5% mortality observed in regions using this program. The purpose of the study is to provide evidence that objective methods for detecting high risk children can be used to optimize efficiency of Community-based Management of Acute Malnutrition (CMAM) treatment programs and thus improve child health outcomes.

Conditions

Severe Acute Malnutrition

Outcome Measures

Primary Outcomes (1)

• Inpatient mortality

  survival or death during inpatient care

  From admission to inpatient care until the the earlier of the date of discharge from inpatient care or ten weeks after enrolment

Secondary Outcomes (2)

• Number of Children receiving inpatient care who required escalation of treatment

  From admission to inpatient care until the the earlier of the date of discharge from inpatient care or ten weeks after enrolment

• Number of Children receiving inpatient care who required de-escalation of treatment

  From admission to inpatient care until the the earlier of the date of discharge from inpatient care or ten weeks after enrolment

Eligibility Criteria

• Age: 1 Month - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children between 1-59 months with severe acute malnutrition admitted into inpatient care within CMAM program run by the non-governmental organization called Alliance for International Medical Action (ALIMA) within the University of Maiduguri Teaching Hospital, Maiduguri, Nigeria

You may qualify if:

• Aged 1 to 59 months
• Diagnosed with severe acute malnutrition (criteria for severe acute malnutrition is \<3Z Weight for Height Z score, and/or MUAC \<115mm, and/or bilateral pitting oedema)
• Meet the criteria for admission into inpatient care (failed appetite test, and/or medical conditions).

You may not qualify if:

• \- Children with congenital anomalies that interfere with feeding (ie. cleft lip and/or palate); previous enrolment in this study.

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Alliance for International Medical Action: collaborator
• University of Maiduguri Teaching Hospital: collaborator
• Tampere University: collaborator

Study Sites (1)

University of Maiduguri Teaching Hospital

Maiduguri, Borno State, Nigeria

Location

MeSH Terms

Conditions

Severe Acute Malnutrition

Condition Hierarchy (Ancestors)

Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Chris Parshuram, MD/PHD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: October 12, 2020
• Study Start: July 22, 2019
• Primary Completion: October 25, 2020
• Study Completion: October 30, 2020
• Last Updated: February 2, 2021

Record last verified: 2021-01

Locations

NG (1)