Clinical Trial: An Intervention for Primary Caregivers to Improve Outcomes in Children With Severe Malnutrition
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: The Effect of an Intervention Program for Primary Caregivers on the Development of Children With Severe Malnutrition: A Cluster Randomized Controlled Clinical Trial
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 Summary: 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.
Sponsor: The Hospital for Sick Children
Current Primary Outcome: Malawi Developmental Assessment Tool Score [ Time Frame: 6 months post-discharge from hospital ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Nutritional status based on: mid-upper arm circumference (MUAC) [ Time Frame: 6 months post-discharge from hospital ]MUAC in millimeters
- Nutritional status based on: World Health Organization (WHO) z-scores [ Time Frame: 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 [ Time Frame: 6 months post-discharge from hospital ]Bilateral pitting oedema
- Duration of hospital stay [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days) ]Number of clinical danger signs
- Readmission [ Time Frame: Within 6 months post-discharge from hospital ]
- Mortality [ Time Frame: Within 6 months post-discharge from hospital ]
- Cortisol [ Time Frame: 6 months post-discharge from hospital ]Hair cortisol
Original Secondary Outcome: Same as current
Information By: The Hospital for Sick Children
Dates:
Date Received: February 17, 2017
Date Started: December 2016
Date Completion: December 2018
Last Updated: March 1, 2017
Last Verified: March 2017