An Intervention for Primary Caregivers to Improve Outcomes in Children With Severe Malnutrition

Not Applicable

Completed

• Conditions: Child Malnutrition

• Registration Number: NCT03072433
• Lead Sponsor: The Hospital for Sick Children

Brief Summary

This cluster-randomized controlled trial will evaluate the effectiveness of a four-day hospital-based intervention program for primary caregivers of children with severe malnutrition.

Detailed Description

Mortality rates remain high in hospitalized children with severe malnutrition and long-term impairments in child development exist in children that do survive. Hospitalized children with severe malnutrition will be allocated to an intervention or standard of care group in each one-week cycle. The intervention package consists of a counseling and support program that includes three modules: 1) psychosocial stimulation; 2) nutrition and feeding; and 3) water, sanitation and hygiene. Assessments will be done at baseline (t=0) and follow-up (t=6 months). The primary outcome is child development, which will be assessed using the Malawi Developmental Assessment Tool, a validated tool for gross and fine motor, language, and social development.

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2017-02-17
• Study First Submitted QC: 2017-03-01
• Study First Posted: 2017-03-07
• Primary Completion: 2020-10
• Study Completion: 2020-12
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-21
• Last Update Posted: 2022-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

Inclusion Criteria

• Child 6-59 months of age with severe malnutrition
• Child admitted to hospital because of severe malnutritionwith medical complications as defined by the current World Health Organization guidelines or has no appetite if there are no complications
• Primary caregiver (self-identified) present at hospital.

Exclusion Criteria

• Primary caregiver declined to give informed consent;
• Child with a known terminal illness (i.e. in the opinion of the treating physician the child is likely to die within six months)
• Child requires a surgical procedure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Malawi Developmental Assessment Tool Score	6 months post-discharge from hospital	Gross motor, fine motor, language, and social development

Secondary Outcome Measures

Name	Time	Method
Nutritional status based on: mid-upper arm circumference (MUAC)	6 months post-discharge from hospital	MUAC in millimeters
Nutritional status based on: World Health Organization (WHO) z-scores	6 months post-discharge from hospital	Weight-for-length or -height z-scores and height-for-age z-scores
Nutritional status based on: nutritionally-induced bilateral pitting oedema	6 months post-discharge from hospital	Bilateral pitting oedema
Duration of hospital stay	During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days)	Number of days that hospital treatment is required
Appetite	During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days)	Number of days that nasogastric tube is required
Clinical deterioration	During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days)	Number of clinical danger signs
Readmission	Within 6 months post-discharge from hospital	Requiring inpatient treatment
Mortality	Within 6 months post-discharge from hospital	Inpatient or post-discharge mortality

Trial Locations

Locations (1)

Queen Elizabeth Central Hospital; 🇲🇼 Blantyre, Malawi