Follow-up Visit of High Risk Infants (FU)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00009633
First received: February 1, 2001
Last updated: July 19, 2013
Last verified: June 2013
  Purpose

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.


Condition Phase
Infant, Newborn
Infant, Low Birth Weight
Infant, Small for Gestational Age
Infant, Premature
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Follow-up Visit of High Risk Infants

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To examine the relationship between baseline characteristics and outcome [ Time Frame: Longitudinal database currently funded through 3/31/2016 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 68000
Study Start Date: January 1993
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
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
  • Identifying significant family stress in this population and compliance with medical and developmental care
  • 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.

  Eligibility

Ages Eligible for Study:   18 Months to 26 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria
  • Infants inborn at NRN centers
  • 401-1,000 grams birth weight, and/or 22 0/7 to 26 6/7 weeks (<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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00009633

Contacts
Contact: Betty R. Vohr, MD (401) 274-1122 ext 1235 bvohr@wihri.org
Contact: Rosemary D. Higgins, MD 301-496-5575 higginsr@mail.nih.gov

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Waldemar A. Carlo, MD    205-934-4680    wcarlo@peds.uab.edu   
Contact: Monica V. Collins, RN BSN    (205) 934-4680    mcollins@peds.uab.edu   
Principal Investigator: Waldemar A. Carlo, MD         
Principal Investigator: Myriam Peralta-Carcelen, MD MPH         
United States, California
University of California - Los Angeles Recruiting
Los Angeles, California, United States, 90025
Contact: Uday Devaskar, MD    310-825-9357    udevaskar@mednet.ucla.edu   
Contact: Teresa Chanlaw, BS    (310) 794-4972    tchanlaw@mednet.ucla.edu   
Principal Investigator: Uday Devaskar, MD         
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Krisa P. Van Meurs, MD    650-723-5711    vanmeurs@leland.stanford.edu   
Contact: M. Bethany Ball, BS CCRC    (650) 725-8342    mbball@stanford.edu   
Principal Investigator: Krisa P. Van Meurs, MD         
Principal Investigator: Susan R. Hintz, MD         
University of California at San Diego Completed
San Diego, California, United States, 92103-8774
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06504
Contact: Richard A. Ehrenkranz, MD    203-688-2895    richard.ehrenkranz@yale.edu   
Contact: Monica Konstantino, RN BSN    (203) 688-7987    monica.konstantino@yale.edu   
Principal Investigator: Richard A. Ehrenkranz, MD         
United States, District of Columbia
George Washington University Completed
Washington, District of Columbia, United States, 20052
United States, Florida
University of Miami Completed
Miami, Florida, United States, 33136
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30303
Contact: Barbara J. Stoll, MD    404-727-5740    barbara_stoll@oz.ped.emory.edu   
Contact: Ellen Hale, RN BS    (404) 616-4218    ellen_hale@oz.ped.emory.edu   
Principal Investigator: Barbara J. Stoll, MD         
Principal Investigator: Ira Adams-Chapman, MD         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Brenda B. Poindexter, MD MS    317-274-4768    bpoindex@iupui.edu   
Contact: Leslie D. Wilson, RN BSN    (317) 274-8255    ldw@iupui.edu   
Principal Investigator: Brenda B. Poindexter, MD MS         
Principal Investigator: Anna M. Dusick, MD FAAP         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Edward F. Bell, MD    319-356-4006    edward-bell@uiowa.edu   
Contact: Karen J. Johnson, RN BSN    (319) 356-2924    karen-johnson@uiowa.edu   
Principal Investigator: Edward F. Bell, MD         
Principal Investigator: Michael J. Acarregui, MD         
United States, Massachusetts
Tufts Medical Center Completed
Boston, Massachusetts, United States, 02111
Harvard University Completed
Cambridge, Massachusetts, United States, 02138
United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: Seetha Shankaran, MD    313-745-1436    sshankar@med.wayne.edu   
Contact: Rebecca Bara, RN BSN    (313) 993-7216    rbara@med.wayne.edu   
Principal Investigator: Seetha Shankaran, MD         
Principal Investigator: Athina Pappas, MD         
United States, Missouri
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: William Truog, MD    816-234-3592    wtruog@cmh.edu   
Contact: Cheri Gauldin, BSN    (816) 234-3920    cagauldin@cmh.edu   
Principal Investigator: William Truog, MD         
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Kristi L. Watterberg, MD    505-272-0180    kwatterberg@salud.unm.edu   
Contact: Conra Backstrom Lacy, RN    (505) 272-0367    cbackstrom@salud.unm.edu   
Principal Investigator: Kristi L. Watterberg, MD         
Principal Investigator: Janell Fuller, MD         
United States, New York
University of Rochester Completed
Rochester, New York, United States, 14642
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Carl T D'Angio, MD    585-273-4911    carl_dangio@urmc.rochester.edu   
Contact: Holly Wadkins    585-275-0218    Holly_Wadkins@urmc.rochester.edu   
Principal Investigator: Carl T D'Angio, MD         
United States, North Carolina
Wake Forest University Completed
Charlotte, North Carolina, United States, 27157
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Ronald N. Goldberg, MD    919-681-6025    goldb008@mc.duke.edu   
Contact: Kimberly A. Fisher, PhD    (919) 681-4913    kimberley.fisher@duke.edu   
Principal Investigator: Ronald N. Goldberg, MD         
Principal Investigator: Ricki F. Goldstein, MD         
RTI International Active, not recruiting
Durham, North Carolina, United States, 27705
United States, Ohio
Cincinnati Children's Medical Center Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Kurt Schibler, MD    513-636-3972    kurt.schibler@cchmc.org   
Contact: Cathy Grisby, BSN CCRC    (513) 558-4953    grisbyca@email.uc.edu   
Principal Investigator: Kurt Schibler, MD         
Principal Investigator: Jean J. Steichen, MD         
Case Western Reserve University, Rainbow Babies and Children's Hospital Recruiting
Cleveland, Ohio, United States, 44106
Contact: Michele C. Walsh, MD MS    216-844-3759    mcw3@cwru.edu   
Contact: Nancy S. Newman, BA RN    (216) 368-3084    nxs5@cwru.edu   
Principal Investigator: Michele C. Walsh, MD MS         
Principal Investigator: Deanne E. Wilson-Costello, MD         
Research Institute at Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Leif Nelin, MD    614-722-3030    Leif.Nelin@nationwidechildrens.org   
Contact: Chris Fortney, MS, RN    614-722-6489    christine.fortney@nationwidechildrens.org   
Principal Investigator: Leif Nelin, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Barbara Schmidt, MD    215-662-3228    barbara.schmidt@uphs.upenn.edu   
Contact: Aasma Chaudhary, BS    215-615-5442    aasma.chaudhary@uphs.upenn.edu   
Principal Investigator: Barbara Schmidt, MD         
United States, Rhode Island
Brown University, Women & Infants Hospital of Rhode Island Recruiting
Providence, Rhode Island, United States, 02905
Contact: Abbot R. Laptook, MD    401-274-1122    alaptook@WIHRI.org   
Contact: Angelita Hensman    (401) 274-1122    ahensman@wihri.org   
Principal Investigator: Abbot R. Laptook, MD         
Principal Investigator: Betty R. Vohr, MD         
United States, Tennessee
University of Tennessee Completed
Memphis, Tennessee, United States, 38163
United States, Texas
University of Texas Southwestern Medical Center at Dallas Recruiting
Dallas, Texas, United States, 75235
Contact: Pablo J. Sanchez, MD    214-648-3753    Pablo.Sanchez@UTSouthwestern.edu   
Contact: Diana M. Vasil, RNC-NIC    (214) 648-3789    Diana.Vasil@utsouthwestern.edu   
Principal Investigator: Pablo J. Sanchez, MD         
Principal Investigator: Roy J. Heyne, MD         
University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Kathleen A. Kennedy, MD MPH    713-500-6708    Kathleen.A.Kennedy@uth.tmc.edu   
Contact: Georgia E. McDavid, RN    (713) 500-5734    Georgia.E.McDavid@uth.tmc.edu   
Principal Investigator: Kathleen A. Kennedy, MD MPH         
Principal Investigator: Jon E. Tyson, MD MPH         
Principal Investigator: Patricia W. Evans, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Roger G. Faix, MD    801-581-7052    roger.faix@hsc.utah.edu   
Contact: Karen A. Osborne, RN BSN    (801) 213-3298    karen.osborne@hsc.utah.edu   
Principal Investigator: Roger G. Faix, MD         
Principal Investigator: Anna Bodnar, MD         
Sponsors and Collaborators
Investigators
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: Ronald N. Goldberg, MD Duke University
Principal Investigator: Barbara J. Stoll, MD Emory University
Principal Investigator: Brenda B. Poindexter, MD MS Indiana University
Principal Investigator: Abhik Das, PhD RTI International
Principal Investigator: Krisa P. Van Meurs, MD Stanford University
Principal Investigator: Ivan D. Frantz III, MD Tufts Medical Center
Principal Investigator: Kurt Schibler, MD Cincinnati Children's Medical Center
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: Pablo J. Sanchez, MD University of Texas Southwestern Medical Center at Dallas
Principal Investigator: Kathleen A. Kennedy, MD MPH The University of Texas Health Science Center, Houston
Principal Investigator: Roger G. Faix, MD University of Utah
Principal Investigator: Seetha Shankaran, MD Wayne State University
Principal Investigator: Richard A. Ehrenkranz, MD Yale University
Principal Investigator: William Truog, MD Children's Mercy Hospital-Kansas City, MO
Principal Investigator: Leif Nelin, MD Research Institute at Nationwide Children's Hospital
Principal Investigator: Uday Devaskar, MD University of California, Los Angeles
Principal Investigator: Carl T D'Angio, MD University of Rochester
Principal Investigator: Barbara Schmidt, MD University of Pennsylvania
  More Information

Additional Information:
Publications:

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00009633     History of Changes
Other Study ID Numbers: NICHD-NRN-0007, U01HD019897, U01HD021466, U10HD021364, U10HD021373, U10HD021385, U10HD021397, U10HD021415, U01HD021438, U10HD027851, U10HD027853, U10HD027856, U10HD027871, U10HD027880, U10HD027881, U10HD027904, U10HD034167, U10HD034216, U10HD036790, U10HD040461, U10HD040492, U10HD040498, U10HD040521, U10HD040689, U10HD042638, U10HD053089, U10HD053109, U10HD053119, U10HD053124, UL1RR024139, UL1RR025744, M01RR000030, M01RR000032, M01RR000039, M01RR000044, M01RR000054, M01RR000059, M01RR000064, M01RR000070, M01RR000080, M01RR000633, M01RR000750, M01RR000997, M01RR008084, M01RR001032, M01RR002172, M01RR002635, M01RR007122, M01RR016587
Study First Received: February 1, 2001
Last Updated: July 19, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
NICHD Neonatal Research Network
Extremely Low Birth Weight (ELBW)
Prematurity
Neurodevelopmental Outcome
Follow up studies

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014