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NCT00009633Recruiting

Follow-up Visit of High Risk Infants

NICHD Neonatal Research Network

Start Date

4/1/1993

Completion Date

3/31/2030

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.

Eligibility Criteria

Age Range: No minimum to No maximum

* Infants inborn at NRN centers * \<27 weeks gestational age * Infants enrolled in one or more additional NICHD NRN Follow-up studies. For infants that do not meet the inclusion criteria above, inclusion and exclusion criteria are determined by the criteria for the additional trial(s). In these cases, infants that are larger than 1,000 grams and/or older than 27 weeks may be included in the FU Study. Note: These inclusion criteria were changed as of 1/1/2008. Prior to this date, infants with birth weights between 401 and 1500 grams who were admitted to NRN NICUs within 14 days of birth were included in the database.

Interventions

OTHER

No Intervention

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Conditions

Infant, NewbornInfant, Low Birth WeightInfant, Small for Gestational AgeInfant, Premature

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35233

United States

University of California - Los Angeles

Los Angeles, California 90025

United States

Stanford University

Palo Alto, California 94304

United States

University of California at San Diego

San Diego, California 92103-8774

United States

Sharp Mary Birch Hospital for Women & Newborns

San Diego, California 92123

United States

Yale University

New Haven, Connecticut 06504

United States

George Washington University

Washington D.C., District of Columbia 20052

United States

University of Miami

Miami, Florida 33136

United States

Emory University

Atlanta, Georgia 30303

United States

Northwestern Lurie Children's Hospital of Chicago

Chicago, Illinois 60611

United States

Indiana University

Indianapolis, Indiana 46202

United States

University of Iowa

Iowa City, Iowa 52242

United States

Tufts Medical Center

Boston, Massachusetts 02111

United States

Harvard University

Cambridge, Massachusetts 02138

United States

Wayne State University

Detroit, Michigan 48201

United States

University of Mississippi Medical Center - Children's of Mississippi

Jackson, Mississippi 39216

United States

Children's Mercy Hospital

Kansas City, Missouri 64108

United States

University of New Mexico

Albuquerque, New Mexico 87131

United States

University of Rochester

Rochester, New York 14642

United States

Wake Forest University

Charlotte, North Carolina 27157

United States

RTI International

Durham, North Carolina 27705

United States

Duke University

Durham, North Carolina 27710

United States

Cincinnati Children's Medical Center

Cincinnati, Ohio 45267

United States

Case Western Reserve University, Rainbow Babies and Children's Hospital

Cleveland, Ohio 44106

United States

Research Institute at Nationwide Children's Hospital

Columbus, Ohio 43205

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Brown University, Women & Infants Hospital of Rhode Island

Providence, Rhode Island 02905

United States

University of Tennessee

Memphis, Tennessee 38163

United States

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas 75235

United States

University of Texas Health Science Center at Houston

Houston, Texas 77030

United States

University of Utah

Salt Lake City, Utah 84108

United States