Improving the Outcomes of Community-based Management of Acute Malnutrition

Severe Acute Malnutrition Clinical Trial

Official title:

Improving the Outcomes of Community-based Management of Acute Malnutrition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04582773
• Other study ID #: REB1000063224
• Status: Completed
• Start date: July 22, 2019
• Est. completion date: October 30, 2020

Study information

• Verified date: January 2021
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1087
• Est. completion date: October 30, 2020
• Est. primary completion date: October 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 59 Months

Eligibility

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.

Related Conditions & MeSH terms

• Malnutrition
• Severe Acute Malnutrition

Locations

Country	Name	City	State
Nigeria	University of Maiduguri Teaching Hospital	Maiduguri	Borno

Sponsors (4)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Alliance for International Medical Action, Tampere University, University of Maiduguri Teaching Hospital

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Children receiving inpatient care who required escalation of treatment	transfer from unit of lower to higher level of care within inpatient treatment	From admission to inpatient care until the the earlier of the date of discharge from inpatient care or ten weeks after enrolment
Secondary	Number of Children receiving inpatient care who required de-escalation of treatment	transfer from unit of higher to lower level of care within inpatient treatment	From admission to inpatient care until the the earlier of the date of discharge from inpatient care or ten weeks after enrolment