Trial of Home Visitation Among Infants With Failure To Thrive
FTT
Growth and Development Longitudinal Follow-Up
1 other identifier
interventional
130
1 country
1
Brief Summary
- 1.Children in the home intervention group will have better growth (increase in weight and height) than children in the control group.
- 2.Children in the home intervention group will have better behavior than children in the control group.
- 3.Children in the home intervention group will have better academic performance than children in the control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 1989
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 1989
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 1995
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 1995
CompletedFirst Submitted
Initial submission to the registry
June 5, 2007
CompletedFirst Posted
Study publicly available on registry
June 7, 2007
CompletedApril 14, 2020
April 1, 2020
6.9 years
June 5, 2007
April 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Growth, behavior, academic performance
20 years
Growth
20 years
Interventions
Homw visits scheduled weekly for one year.
Eligibility Criteria
You may qualify if:
- Age \< 25 months, at least 35 weeks gestational age, birth weight appropriate for gestational age, current weight-for-age \< 5th percentile or weight-for-length \< 10th percentile or weight for age crossing two major centiles and falling below the 25th percentile.
You may not qualify if:
- No congenital problems or developmental disabilities.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Maryland Growth and Nutrition Clinic
Baltimore, Maryland, 21201, United States
Related Publications (2)
Black MM, Dubowitz H, Krishnakumar A, Starr RH Jr. Early intervention and recovery among children with failure to thrive: follow-up at age 8. Pediatrics. 2007 Jul;120(1):59-69. doi: 10.1542/peds.2006-1657.
PMID: 17606562BACKGROUNDBlack MM, Dubowitz H, Hutcheson J, Berenson-Howard J, Starr RH Jr. A randomized clinical trial of home intervention for children with failure to thrive. Pediatrics. 1995 Jun;95(6):807-14.
PMID: 7539121RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maureen M Black, Ph.D.
University of Maryland, College Park
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 5, 2007
First Posted
June 7, 2007
Study Start
January 1, 1989
Primary Completion
December 1, 1995
Study Completion
December 1, 1995
Last Updated
April 14, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will share
Participants have been enrolled into a study funded by the Office of Child Abuse and Neglect with Dr. Dubowitz as PI.