Clinical trial NCT04582773: Improving the Outcomes of Community-based Management of Acute Malnutrition
Official title: Improving the Outcomes of Community-based Management of Acute Malnutrition
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Acute Malnutrition
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Alliance for International Medical Action
name: University of Maiduguri Teaching Hospital
name: Tampere University
First posted: 2020-10-12
Enrollment: 1087
Sex: ALL
Minimum age (years): 1
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Inpatient mortality
timeFrame: From admission to inpatient care until the the earlier of the date of discharge from inpatient care or ten weeks after enrolment
Secondary outcomes:
measure: Number of Children receiving inpatient care who required escalation of treatment
timeFrame: From admission to inpatient care until the the earlier of the date of discharge from inpatient care or ten weeks after enrolment
measure: Number of Children receiving inpatient care who required de-escalation of treatment
timeFrame: From admission to inpatient care until the the earlier of the date of discharge from inpatient care or ten weeks after enrolment
Other outcomes:
Locations:
city: Maiduguri
country: Nigeria
facility: University of Maiduguri Teaching Hospital
state: Borno
Study officials:
affiliation: The Hospital for Sick Children
name: Chris Parshuram, MD/PHD
role: PRINCIPAL_INVESTIGATOR
References: