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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00483691
First Posted: June 7, 2007
Last Update Posted: April 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Maureen Black, University of Maryland
  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
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Growth and Development Longitudinal Follow-Up

Further study details as provided by Maureen Black, University of Maryland:

Primary Outcome Measures:
  • Growth, behavior, academic performance [ Time Frame: 20 years ]
  • Growth [ Time Frame: 20 years ]

Enrollment: 130
Study Start Date: January 1989
Study Completion Date: December 1995
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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 24 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Maureen Black, Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT00483691     History of Changes
Other Study ID Numbers: FTT
First Submitted: June 5, 2007
First Posted: June 7, 2007
Last Update Posted: April 24, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Participants have been enrolled into a study funded by the Office of Child Abuse and Neglect with Dr. Dubowitz as PI.

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

Additional relevant MeSH terms:
Failure to Thrive
Signs and Symptoms