RECRUITING

Follow-up Visit of High Risk Infants

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Follow-up Visit of High Risk Infants

Quick Facts

Study Start:1993-01
Study Completion:2030-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT00009633

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.

Ages Eligible for Study:18 Months to 26 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Susan R Hintz, MD, MS Epi
CONTACT
srhintz@stanford.edu
Abhik Das, PhD
CONTACT
301 230 4640
adas@rti.org

Principal Investigator

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

Study Locations (Sites)

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, 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

Collaborators and Investigators

Sponsor: NICHD Neonatal Research Network

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

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 Registration Dates

Study Start Date1993-01
Study Completion Date2030-03-31

Study Record Updates

Study Start Date1993-01
Study Completion Date2030-03-31

Terms related to this study

Keywords Provided by Researchers

  • NICHD Neonatal Research Network
  • Extremely Low Birth Weight (ELBW)
  • Prematurity
  • Neurodevelopmental Outcome
  • Follow up studies

Additional Relevant MeSH Terms

  • Infant, Newborn
  • Infant, Low Birth Weight
  • Infant, Small for Gestational Age
  • Infant, Premature