Trial of Home Visitation Among Infants With Failure To Thrive (FTT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by University of Maryland.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Maryland
ClinicalTrials.gov Identifier:
NCT00483691
First received: June 5, 2007
Last updated: September 17, 2008
Last verified: September 2008
  Purpose
  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.

Condition Intervention
Failure to Thrive
Behavioral: Home Visit

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Growth and Development Longitudinal Follow-Up

Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Growth, behavior, academic performance [ Time Frame: 20 years ] [ Designated as safety issue: No ]
  • Growth [ Time Frame: 20 years ] [ Designated as safety issue: No ]

Enrollment: 130
Study Start Date: January 1989
Estimated Study Completion Date: May 2010
Primary Completion Date: December 1995 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Home Visit
    Homw visits scheduled weekly for one year.
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Month to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • No congenital problems or developmental disabilities.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483691

Locations
United States, Maryland
University of Maryland Growth and Nutrition Clinic
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Maureen M Black, Ph.D. University of Maryland
  More Information

Publications:
Black MM, Dubowitz H, Krishnakumar A, Starr RH. Early intervention and recovery among children with failure to thrive: Follow-up at age 8. Pediatrics 120 (1):59-69, 2007.

Responsible Party: Maureen Black, University of Maryland
ClinicalTrials.gov Identifier: NCT00483691     History of Changes
Other Study ID Numbers: FTT
Study First Received: June 5, 2007
Last Updated: September 17, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
Intervention
Home Visit
Growth
Child Development

Additional relevant MeSH terms:
Failure to Thrive
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2014