Follow-up Visit of High Risk Infants
- Conditions
- Infant, PrematureInfant, NewbornInfant, Low Birth WeightInfant, Small for Gestational Age
- Registration Number
- NCT00009633
- Lead Sponsor
- NICHD Neonatal Research Network
- Brief Summary
The NICHD Neonatal Research Network's Follow-Up study is a multi-center cohort in which surviving extremely low birth-weight infants born in participating network centers receive neurodevelopmental, neurosensory and functional assessments at 22-26 months corrected age (Infants born prior to July 1, 2012 were seen at 18-22 months corrected age). Data regarding pregnancy and neonatal outcome are collected prospectively. The goal is to identify potential maternal and neonatal risk factors that may affect infant neurodevelopment.
- Detailed Description
The NICHD Neonatal Research Network's Follow-Up study is a multi-center cohort study in which surviving extremely low birth-weight infants undergo neurodevelopmental, neurosensory and functional assessments at 22-26 months corrected age (Infants born prior to July 1, 2012 were seen at 18-22 month corrected age). The goal of the study is to identify potential maternal and neonatal risk factors that may affect infant neurodevelopment, including:
* Evaluating development of motor skills, cognitive skills, language and behavior
* Determining mortality and the prevalence of specific medical conditions
* Assessing the relationship between growth and neurodevelopmental outcome
* Assessing the relationship between the socioeconomic status and developmental outcome
* Assessing the use of special support services and early intervention programs by this population
* Evaluating the need for follow-up at school age.
The scheduled evaluations collect: demographic information; socioeconomic status; medical history; medications; medical equipment required; growth data; a detailed neurologic examination; Bayley Scales of Infant Development (mental, motor, infant behavior); Child Behavior Checklist.
A sub-study will assess a reference group comprised of a limited number of healthy term infants born in Network centers to meet the following three aims: 1) to avoid potential ascertainment biases due to examiner expectations when only extremely preterm or other high-risk infants are assessed 2) in the absence of well-developed norms for the Bayley Scales, to define thresholds for impairment based on data for a representative sample of healthy children born at term in our centers and concurrently assessed by the same examiners as for our high-risk infants; and 3) to help identify and address when "drift" occurs over time in conducting and scoring Bayley assessments.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 68000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner Longitudinal database currently funded through 3/31/2016
- Secondary Outcome Measures
Name Time Method To provide data for hypothesis formulation and sample size calculation for Network multi-center studies Longitudinal database currently funded through 3/31/2016 To examine the relationship between baseline characteristics and outcome Longitudinal database currently funded through 3/31/2016
Trial Locations
- Locations (31)
University of California - Los Angeles
🇺🇸Los Angeles, California, United States
Northwestern Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
Research Institute at Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
University of Mississippi Medical Center - Children's of Mississippi
🇺🇸Jackson, Mississippi, United States
University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Brown University, Women & Infants Hospital of Rhode Island
🇺🇸Providence, Rhode Island, United States
University of Texas Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of California at San Diego
🇺🇸San Diego, California, United States
RTI International
🇺🇸Durham, North Carolina, United States
Duke University
🇺🇸Durham, North Carolina, United States
Cincinnati Children's Medical Center
🇺🇸Cincinnati, Ohio, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Sharp Mary Birch Hospital for Women & Newborns
🇺🇸San Diego, California, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
University of Rochester
🇺🇸Rochester, New York, United States
Wake Forest University
🇺🇸Charlotte, North Carolina, United States
Case Western Reserve University, Rainbow Babies and Children's Hospital
🇺🇸Cleveland, Ohio, United States
Emory University
🇺🇸Atlanta, Georgia, United States
George Washington University
🇺🇸Washington, District of Columbia, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Stanford University
🇺🇸Palo Alto, California, United States
University of Miami
🇺🇸Miami, Florida, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Harvard University
🇺🇸Cambridge, Massachusetts, United States
Wayne State University
🇺🇸Detroit, Michigan, United States
University of Tennessee
🇺🇸Memphis, Tennessee, United States