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.
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.
Study Type
OBSERVATIONAL
Enrollment
68,000
No Intervention
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGUniversity of California - Los Angeles
Los Angeles, California, United States
RECRUITINGStanford University
Palo Alto, California, United States
RECRUITINGUniversity of California at San Diego
San Diego, California, United States
To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner
Time frame: Longitudinal database currently funded through 3/31/2016
To examine the relationship between baseline characteristics and outcome
Time frame: Longitudinal database currently funded through 3/31/2016
To provide data for hypothesis formulation and sample size calculation for Network multi-center studies
Time frame: Longitudinal database currently funded through 3/31/2016
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Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, United States
NOT_YET_RECRUITINGYale University
New Haven, Connecticut, United States
COMPLETEDGeorge Washington University
Washington D.C., District of Columbia, United States
COMPLETEDUniversity of Miami
Miami, Florida, United States
COMPLETEDEmory University
Atlanta, Georgia, United States
RECRUITINGNorthwestern Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
NOT_YET_RECRUITING...and 21 more locations