Follow-up Visit of High Risk Infants

Last updated: February 11, 2025
Sponsor: NICHD Neonatal Research Network
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

No Intervention

Clinical Study ID

NCT00009633
NICHD-NRN-0007
M01RR008084
UG1HD040689
U10HD053089
M01RR001032
U10HD021415
UG1HD040492
U10HD034216
UG1HD112079
U10HD027904
UG1HD068278
U10HD040689
UG1HD112100
U10HD053124
U10HD053119
UG1HD087226
U10HD021385
UG1HD068263
UG1HD053109
UG1HD068244
UG1HD112093
UG1HD034216
U10HD027881
U10HD040521
U10HD053109
M01RR016587
UG1HD112097
U10HD036790
UG1HD027880
U10HD040461
M01RR007122
U10HD034167
UG1HD021364
U10HD021397
UL1RR025744
U10HD021364
U10HD027880
M01RR000633
U10HD027853
M01RR002635
U01HD021438
UL1RR024139
U24HD095254
U10HD042638
UG1HD053089
U10HD027871
UG1HD027853
M01RR000750
U01HD021466
U10HD027851
U10HD021373
UG1HD027904
M01RR000997
M01RR002172
UG1HD027851
U10HD040492
U01HD019897
U10HD040498
U10HD027856
  • Ages 18-26
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

  • 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.

Study Design

Total Participants: 68000
Treatment Group(s): 1
Primary Treatment: No Intervention
Phase:
Study Start date:
April 01, 1993
Estimated Completion Date:
March 31, 2030

Study 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.

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • University of California - Los Angeles

    Los Angeles, California 90025
    United States

    Active - Recruiting

  • Stanford University

    Palo Alto, California 94304
    United States

    Active - Recruiting

  • Sharp Mary Birch Hospital for Women & Newborns

    San Diego, California 92123
    United States

    Site Not Available

  • University of California at San Diego

    San Diego, California 92103-8774
    United States

    Completed

  • Yale University

    New Haven, Connecticut 06504
    United States

    Completed

  • George Washington University

    Washington, District of Columbia 20052
    United States

    Completed

  • George Washington University

    Washington, D.C., District of Columbia 20052
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33136
    United States

    Completed

  • Emory University

    Atlanta, Georgia 30303
    United States

    Active - Recruiting

  • Northwestern Lurie Children's Hospital of Chicago

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Indiana University

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Tufts Medical Center

    Boston, Massachusetts 02111
    United States

    Completed

  • Harvard University

    Cambridge, Massachusetts 02138
    United States

    Completed

  • Wayne State University

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • University of Mississippi Medical Center - Children's of Mississippi

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Children's Mercy Hospital

    Kansas City, Missouri 64108
    United States

    Active - Recruiting

  • University of New Mexico

    Albuquerque, New Mexico 87131
    United States

    Active - Recruiting

  • University of Rochester

    Rochester, New York 14642
    United States

    Site Not Available

  • Wake Forest University

    Charlotte, North Carolina 27157
    United States

    Completed

  • Duke University

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • RTI International

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Cincinnati Children's Medical Center

    Cincinnati, Ohio 45267
    United States

    Active - Recruiting

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

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Research Institute at Nationwide Children's Hospital

    Columbus, Ohio 43205
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Brown University, Women & Infants Hospital of Rhode Island

    Providence, Rhode Island 02905
    United States

    Site Not Available

  • University of Tennessee

    Memphis, Tennessee 38163
    United States

    Completed

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas 75235
    United States

    Active - Recruiting

  • University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Utah

    Salt Lake City, Utah 84108
    United States

    Active - Recruiting

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