Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00483691
Status:
COMPLETED
Last Update Posted:
2020-04-14
First Post:
2007-06-05
Brief Title:
Trial of Home Visitation Among Infants With Failure To Thrive
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Growth and Development Longitudinal Follow-Up
Status:
COMPLETED
Status Verified Date:
2020-04
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:
FTT
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
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
Detailed Description:
During the first years of life when energy needs are high growth serves as an objective measure of childrens 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 childrens 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 childrens behavior and maternal and family functioning Developmental assessments were administered by psychology graduate students supervised by a pediatric psychologist A home visit was scheduled within two weeks of the initial evaluation
Children with FTT were treated in an interdisciplinary clinic Based on a randomization procedure stratified by race gender and infant age to ensure equivalence across groups children with FTT were randomized to receive either the clinical intervention plus home intervention FTT-HI or the clinical intervention only FTT-CO
The intervention was based on ecological theory and included a therapeutic alliance between the interventionist and the caregiver support to the caregivers personal family and environmental needs opportunities to model and promote responsive parent-infant interaction and problem-solving strategies regarding personal parenting and childrens issues The Hawaii Early Learning Program was used as a curriculum guide
The intervention was delivered by three part-time lay home visitors employed by a community-based agency specializing in early intervention The home visitors received an eight-session training program and were supervised by a community health nurse The home visitors had portable mats and toys to demonstrate developmentally appropriate activities and to facilitate parent-child interaction They did not focus on nutrition or feeding behavior and they did not weigh the children One-hour visits were scheduled weekly for one year the number of visits varied from 0 to 47
The children and caregivers return for regularly scheduled evaluations throughout the childs life Evaluators are unaware of their growth or intervention status Caregivers provide the name of the childrens school and requests are sent for information on classroom behavior Families and teachers are compensated for participating in evaluations
The outcome measures are growth cognition academic performance and social behavior Evaluators are unaware of the childrens growth history or group assignment Standardized measures are used
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 childrens behavior and maternal and family functioning Developmental assessments were administered by psychology graduate students supervised by a pediatric psychologist A home visit was scheduled within two weeks of the initial evaluation
Children with FTT were treated in an interdisciplinary clinic Based on a randomization procedure stratified by race gender and infant age to ensure equivalence across groups children with FTT were randomized to receive either the clinical intervention plus home intervention FTT-HI or the clinical intervention only FTT-CO
The intervention was based on ecological theory and included a therapeutic alliance between the interventionist and the caregiver support to the caregivers personal family and environmental needs opportunities to model and promote responsive parent-infant interaction and problem-solving strategies regarding personal parenting and childrens issues The Hawaii Early Learning Program was used as a curriculum guide
The intervention was delivered by three part-time lay home visitors employed by a community-based agency specializing in early intervention The home visitors received an eight-session training program and were supervised by a community health nurse The home visitors had portable mats and toys to demonstrate developmentally appropriate activities and to facilitate parent-child interaction They did not focus on nutrition or feeding behavior and they did not weigh the children One-hour visits were scheduled weekly for one year the number of visits varied from 0 to 47
The children and caregivers return for regularly scheduled evaluations throughout the childs life Evaluators are unaware of their growth or intervention status Caregivers provide the name of the childrens school and requests are sent for information on classroom behavior Families and teachers are compensated for participating in evaluations
The outcome measures are growth cognition academic performance and social behavior Evaluators are unaware of the childrens growth history or group assignment Standardized measures are used
Study Oversight
Has Oversight DMC:
None
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?:
None