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Completed

NCT Number: NCT04582773

Improving the Outcomes of Community-based Management of Acute Malnutrition

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.

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Key information

Conditions

Severe Acute Malnutrition Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

1 month–59 month

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Maiduguri Teaching Hospital

Maiduguri, Borno State, Nigeria

About this study

A prospective observational study in inpatient care within community-based management of acute malnutrition(CMAM) program run by the nongovernmental organization called Alliance for International Medical Action (ALIMA) within the University of Maiduguri Teaching Hospital, Maiduguri, Nigeria

The objectives of the study are to validate the BedsidePEWS scores as a measure of severity of illness in children who are treated as inpatients for severe acute malnutrition and to compare the BedsidePEWS scores with other risk factors associated for mortality and relapse of children with severe acute malnutrition. The design is a prospective observational study of 1000 children admitted as inpatients in a CMAM program in Maidaguri Teaching Hospital in Maidaguri, Nigeria. Data collection (estimated duration 4-5 months) involves vital signs, and risk factor assessment every 12 hours for duration of hospitalization. Blood test for hemoglobin and malaria will be done once upon admission. Outcomes will be measured every 12 hours and include mortality and/or escalation and de-escalation of care. Logistic regression with significance testing will be used to compare BedsidePEWS scores and risk factors between patients and among individual patients within the outcome categories. Exploratory sensitivity analyses will repeat the main logistic regression analyses to evaluate the performance of partial BedsidePEWS score in patients with missing data of 1-3 of the 7 components, by randomly removing 1-3 data elements from the score calculation from patients, and by removing systolic blood pressure from scoring.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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).

Study amendment for inclusion: children with and without severe acute malnutrition admitted to emergency pediatric unit (EPU)

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Inpatient mortality

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

    survival or death during inpatient care

Secondary outcomes

  1. Number of Children receiving inpatient care who required escalation of treatment

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

    transfer from unit of lower to higher level of care within inpatient treatment

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

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

    transfer from unit of higher to lower level of care within inpatient treatment

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Alliance for International Medical Action
  • Tampere University
  • University of Maiduguri Teaching Hospital

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 12, 2020
Registry last updated
Feb 2, 2021

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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