Improving the Outcomes of Community-based Management of A... | NCT04582773

Studies
Improving the Outcomes of Community-based Management of Acute Malnutrition

NCT04582773

Sponsor

The Hospital for Sick Children

Status

Completed

Last Update Posted

Feb 2, 2021Actual

Enrollment

1,087Actual

Phase

Not provided

Conditions

Severe Acute Malnutrition

Interventions

Not provided

Countries

Nigeria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 22, 2019Actual

Primary Completion Date

Oct 25, 2020Actual

Completion Date

Oct 30, 2020Actual

First Submitted Date

Sep 8, 2020

First Submission Date that Met QC Criteria

Oct 5, 2020

First Posted Date

Oct 12, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2021

Last Update Posted Date

Feb 2, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Christopher Parshuram, Principal Investigator, The Hospital for Sick ChildrenPrincipal Investigator

Lead Sponsor

The Hospital for Sick ChildrenOTHER

Collaborators

Name	Class
Alliance for International Medical Action	OTHER
University of Maiduguri Teaching Hospital	UNKNOWN
Tampere University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,087Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
Number of Children receiving inpatient care who required de-escalation of treatment

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

59 Months

Standard Ages

Child

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chris Parshuram, MD/PHD	The Hospital for Sick Children	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Maiduguri Teaching Hospital		Maiduguri	Borno State		Nigeria

Condition Browse Module

MeSH Terms

ID	Term
D000067011	Severe Acute Malnutrition

Ancestor Terms

ID	Term
D044342	Malnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided