Follow-up Visit of High Risk Infants (FU)

November 7, 2023 updated by: NICHD Neonatal Research Network
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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

68000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Abhik Das, PhD
  • Phone Number: 301 230 4640
  • Email: adas@rti.org

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
          • Waldemar A. Carlo, MD
        • Principal Investigator:
          • Myriam Peralta-Carcelen, MD MPH
        • Principal Investigator:
          • Waldemar A. Carlo, MD
    • California
      • Los Angeles, California, United States, 90025
        • Recruiting
        • University of California - Los Angeles
        • Contact:
          • Uday Devaskar, MD
        • Principal Investigator:
          • Uday Devaskar, MD
        • Principal Investigator:
          • Isabell Purdy, MD
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford University
        • Contact:
          • Krisa P. Van Meurs, MD
        • Principal Investigator:
          • Krisa P. Van Meurs, MD
        • Principal Investigator:
          • Susan R. Hintz, MD
      • San Diego, California, United States, 92123
        • Not yet recruiting
        • Sharp Mary Birch Hospital for Women & Newborns
        • Contact:
          • Anup Katheria, MD
        • Principal Investigator:
          • Anup Katheria, MD
      • San Diego, California, United States, 92103-8774
        • Completed
        • University of California at San Diego
    • Connecticut
      • New Haven, Connecticut, United States, 06504
        • Completed
        • Yale University
    • District of Columbia
      • Washington, District of Columbia, United States, 20052
        • Completed
        • George Washington University
    • Florida
      • Miami, Florida, United States, 33136
        • Completed
        • University of Miami
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • Emory University
        • Contact:
          • David P. Carlton, MD
        • Principal Investigator:
          • David P. Carlton, MD
        • Principal Investigator:
          • Ira Adams-Chapman, MD
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Not yet recruiting
        • Northwestern Lurie Children's Hospital of Chicago
        • Contact:
          • Aaron Hamvas, MD
        • Principal Investigator:
          • Aaron Hamvas, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University
        • Principal Investigator:
          • Greg Sokol, MD
        • Principal Investigator:
          • Heidi Harmon, MD
        • Contact:
          • Greg Sokol, MD
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa
        • Contact:
          • Edward F. Bell, MD
        • Principal Investigator:
          • Edward F. Bell, MD
        • Principal Investigator:
          • Jane E. Brumbaugh, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Completed
        • Tufts Medical Center
      • Cambridge, Massachusetts, United States, 02138
        • Completed
        • Harvard University
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Wayne State University
        • Contact:
          • Seetha Shankaran, MD
        • Principal Investigator:
          • Seetha Shankaran, MD
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Not yet recruiting
        • University of Mississippi Medical Center - Children's of Mississippi
        • Principal Investigator:
          • Abhay Bhatt, MD
        • Contact:
          • Abhay Bhatt, MD
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • Children's Mercy Hospital
        • Contact:
          • William Truog, MD
        • Principal Investigator:
          • William Truog, MD
        • Principal Investigator:
          • Howard Kilbride, MD
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Recruiting
        • University of New Mexico
        • Contact:
          • Kristi L. Watterberg, MD
        • Principal Investigator:
          • Kristi L. Watterberg, MD
        • Principal Investigator:
          • Janell Fuller, MD
        • Principal Investigator:
          • Jean Lowe, MD
    • New York
      • Rochester, New York, United States, 14642
        • Active, not recruiting
        • University of Rochester
    • North Carolina
      • Charlotte, North Carolina, United States, 27157
        • Completed
        • Wake Forest University
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University
        • Contact:
          • C. Michael Cotten, MD
        • Principal Investigator:
          • C. Michael Cotten, MD
        • Principal Investigator:
          • William F. Malcolm, MD
      • Durham, North Carolina, United States, 27705
        • Active, not recruiting
        • RTI International
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • Cincinnati Children's Medical Center
        • Principal Investigator:
          • Stephanie Merhar, MD
        • Contact:
          • Brenda Poindexter, MD,MS
        • Principal Investigator:
          • Brenda Poindexter, MD
        • Principal Investigator:
          • Kimberly Yolton, PhD
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Case Western Reserve University, Rainbow Babies and Children's Hospital
        • Contact:
          • Michele C. Walsh, MD MS
        • Principal Investigator:
          • Michele C. Walsh, MD MS
        • Principal Investigator:
          • Deanne E. Wilson, MD
      • Columbus, Ohio, United States, 43205
        • Active, not recruiting
        • Research Institute at Nationwide Children's Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania
        • Contact:
          • Eric Eichenwald, MD
        • Principal Investigator:
          • Eric Eichenwald, MD
        • Principal Investigator:
          • Sara DeMauro, MD
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Active, not recruiting
        • Brown University, Women & Infants Hospital of Rhode Island
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • Completed
        • University of Tennessee
    • Texas
      • Dallas, Texas, United States, 75235
        • Recruiting
        • University of Texas Southwestern Medical Center at Dallas
        • Contact:
          • Myra H Wyckoff, MD
        • Principal Investigator:
          • Myra H. Wyckfoff, MD
        • Principal Investigator:
          • Roy J. Heyne, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas Health Science Center at Houston
        • Contact:
          • Jon Tyson, MD MPH
        • Principal Investigator:
          • Jon E. Tyson, MD MPH
        • Principal Investigator:
          • Andrea F. Duncan, MD
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Recruiting
        • University of Utah
        • Contact:
          • Bradley Yoder, MD
        • Principal Investigator:
          • Sara Winter, MD
        • Principal Investigator:
          • Bradley Yoder, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 2 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Infants born at 401-1000 grams birth weight and/or <29 weeks gestational age

Description

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Longitudinal database currently funded through 3/31/2016

Secondary Outcome Measures

Outcome Measure
Time Frame
To examine the relationship between baseline characteristics and outcome
Time Frame: Longitudinal database currently funded through 3/31/2016
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
Longitudinal database currently funded through 3/31/2016

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NICHD Neonatal Research Network

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Center for Research Resources (NCRR)

Investigators

  • Principal Investigator: C. Michael Cotten, MD, MHS, Duke University
  • Principal Investigator: David P. Carlton, MD, Emory University
  • Principal Investigator: Brenda B. Poindexter, MD, Children's Hospital Medical Center, Cincinnati
  • Principal Investigator: Myra H. Wyckoff, MD, University of Texas, Southwestern Medical Center at Dallas
  • Principal Investigator: Bradley A. Yoder, MD, University of Utah
  • Principal Investigator: William E. Truog, MD, Children's Mercy Hospital Kansas City
  • Principal Investigator: Pablo J. Sanchez, MD, Research Institute at Nationwide Children's Hospital
  • Principal Investigator: Eric C Eichenwald, MD, University of Pennsylvania
  • Principal Investigator: Seetha Shankaran, MD, Wayne State University
  • Principal Investigator: Abbot R. Laptook, MD, Brown University, Women & Infants Hospital of Rhode Island
  • Principal Investigator: Michele C. Walsh, MD MS, Case Western Reserve University, Rainbow Babies and Children's Hospital
  • Principal Investigator: Greg M. Sokol, MD, Indiana University
  • Principal Investigator: Abhik Das, PhD, RTI International
  • Principal Investigator: Krisa P. Van Meurs, MD, Stanford University
  • Principal Investigator: Waldemar A. Carlo, MD, University of Alabama at Birmingham
  • Principal Investigator: Edward F. Bell, MD, University of Iowa
  • Principal Investigator: Kristi L. Watterberg, MD, University of New Mexico
  • Principal Investigator: Jon E Tyson, MD, MPH, The University of Texas Health Science Center, Houston
  • Principal Investigator: Uday Devaskar, MD, University of California, Los Angeles
  • Principal Investigator: Carl T D'Angio, MD, University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1993

Primary Completion (Estimated)

March 31, 2030

Study Completion (Estimated)

March 31, 2030

Study Registration Dates

First Submitted

February 1, 2001

First Submitted That Met QC Criteria

February 2, 2001

First Posted (Estimated)

February 5, 2001

Study Record Updates

Last Update Posted (Estimated)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NICHD-NRN-0007
  • M01RR000633 (U.S. NIH Grant/Contract)
  • UG1HD087226 (U.S. NIH Grant/Contract)
  • U10HD036790 (U.S. NIH Grant/Contract)
  • U10HD021364 (U.S. NIH Grant/Contract)
  • U10HD021373 (U.S. NIH Grant/Contract)
  • U10HD021385 (U.S. NIH Grant/Contract)
  • U10HD027851 (U.S. NIH Grant/Contract)
  • U10HD027853 (U.S. NIH Grant/Contract)
  • U10HD027856 (U.S. NIH Grant/Contract)
  • U10HD027871 (U.S. NIH Grant/Contract)
  • U10HD027880 (U.S. NIH Grant/Contract)
  • U10HD027904 (U.S. NIH Grant/Contract)
  • U10HD034216 (U.S. NIH Grant/Contract)
  • U10HD040492 (U.S. NIH Grant/Contract)
  • U10HD040689 (U.S. NIH Grant/Contract)
  • U10HD053089 (U.S. NIH Grant/Contract)
  • U10HD053109 (U.S. NIH Grant/Contract)
  • U10HD053119 (U.S. NIH Grant/Contract)
  • U10HD053124 (U.S. NIH Grant/Contract)
  • UL1RR024139 (U.S. NIH Grant/Contract)
  • UL1RR025744 (U.S. NIH Grant/Contract)
  • U01HD019897 (U.S. NIH Grant/Contract)
  • U10HD021415 (U.S. NIH Grant/Contract)
  • U10HD027881 (U.S. NIH Grant/Contract)
  • M01RR008084 (U.S. NIH Grant/Contract)
  • M01RR000750 (U.S. NIH Grant/Contract)
  • M01RR000997 (U.S. NIH Grant/Contract)
  • U10HD021397 (U.S. NIH Grant/Contract)
  • U01HD021466 (U.S. NIH Grant/Contract)
  • U01HD021438 (U.S. NIH Grant/Contract)
  • U10HD034167 (U.S. NIH Grant/Contract)
  • U10HD040461 (U.S. NIH Grant/Contract)
  • U10HD040498 (U.S. NIH Grant/Contract)
  • U10HD040521 (U.S. NIH Grant/Contract)
  • U10HD042638 (U.S. NIH Grant/Contract)
  • M01RR001032 (U.S. NIH Grant/Contract)
  • M01RR002172 (U.S. NIH Grant/Contract)
  • M01RR002635 (U.S. NIH Grant/Contract)
  • M01RR007122 (U.S. NIH Grant/Contract)
  • M01RR016587 (U.S. NIH Grant/Contract)
  • UG1HD112079 (U.S. NIH Grant/Contract)
  • UG1HD112097 (U.S. NIH Grant/Contract)
  • UG1HD112100 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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