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

The Hospital for Sick Children181 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

181

Conditions

Child Malnutrition

Interventions

Counseling Intervention PackageBEHAVIORAL

Daily 45 minutes of group teaching for primary caregivers, followed by 45 minutes of supervised play and stimulation with their children for a total of four days. Teaching modules consist of psychosocial stimulation, nutrition and feeding, and water, sanitation and hygiene practices.

Standard of CareBEHAVIORAL

Nutrition and water sanitation and hygiene counseling at any point prior to discharge from hospital as per the local nutrition rehabilitation unit standard of care. In addition, primary caregivers will be stimulated to play with their children in a play area.

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 5 Years

Medical Language ↔ Plain English

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.

Locations (1)

Queen Elizabeth Central Hospital

Blantyre, Malawi

Outcomes

Primary Outcomes

Malawi Developmental Assessment Tool Score

Gross motor, fine motor, language, and social development

Time frame: 6 months post-discharge from hospital

Secondary Outcomes

Nutritional status based on: mid-upper arm circumference (MUAC)

MUAC in millimeters

Time frame: 6 months post-discharge from hospital

Nutritional status based on: World Health Organization (WHO) z-scores

Weight-for-length or -height z-scores and height-for-age z-scores

Time frame: 6 months post-discharge from hospital

Nutritional status based on: nutritionally-induced bilateral pitting oedema

Bilateral pitting oedema

Time frame: 6 months post-discharge from hospital

Duration of hospital stay

Number of days that hospital treatment is required

Time frame: During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days)

Appetite

Number of days that nasogastric tube is required

Time frame: During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days)

Clinical deterioration

Number of clinical danger signs

Time frame: During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days)

Readmission

Data from ClinicalTrials.gov

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