Clinical Trial: Trial of Home Visitation Among Infants With Failure To Thrive
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Growth and Development Longitudinal Follow-Up
Brief Summary:
- Children in the home intervention group will have better growth (increase in weight and height) than children in the control group.
- Children in the home intervention group will have better behavior than children in the control group.
- Children in the home intervention group will have better academic performance than children in the control group.
Detailed Summary:
During the first years of life when energy needs are high, growth serves as an objective measure of children's well-being. Failure-to-thrive (FTT) occurs when infants' rate of weight gain is below expectations based on age and gender-specific growth charts. The proposed randomized controlled trial evaluates whether a home-based intervention delivered by community health workers is effective in altering patterns of children's growth and development.
Infants were recruited from pediatric primary care clinics serving low-income, urban communities from 1988 through 1993. Eligibility criteria included age < 25 months, at least 35 weeks gestational age and appropriate birth weight for gestational age, and no congenital problems, disabilities, or chronic illnesses.
Children in the FTT group had to meet one of two criteria using age and gender-specific National Center for Health Statistics (NCHS) growth charts: sustained weight-for-age below the 5th percentile, weight-for-length below the 10th percentile or weight for age crossing two major centiles and falling below the 25th percentile. All infants were examined by a pediatrician, who also reviewed their medical charts to ensure that they met criteria for FTT and there were no known syndromes or obvious major organ system dysfunctions, such as congenital heart disease, to account for the growth failure of the infants in the FTT group.
Caregivers were invited to participate in a longitudinal research project, using consent procedures approved by the Institutional Review Board of the University of Maryland, Baltimore. Over 90% of eligible caregivers agreed and participated in an initial evaluation that included measures of growth, standardized developmental assessments, and a 60-minute interview of questionnaires on demographics,
Sponsor: University of Maryland
Current Primary Outcome:
- Growth, behavior, academic performance [ Time Frame: 20 years ]
- Growth [ Time Frame: 20 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of Maryland
Dates:
Date Received: June 5, 2007
Date Started: January 1989
Date Completion:
Last Updated: April 20, 2017
Last Verified: April 2017
