Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-27 @ 11:10 PM
Study NCT ID:
NCT03072433
Status:
COMPLETED
Last Update Posted:
2022-12-22
First Post:
2017-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Intervention for Primary Caregivers to Improve Outcomes in Children With Severe Malnutrition
Sponsor:
The Hospital for Sick Children
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: