Follow-up Visit of High Risk Infants (FU)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by NICHD Neonatal Research Network
Sponsor:
Collaborators:
National Center for Research Resources (NCRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
NICHD Neonatal Research Network
ClinicalTrials.gov Identifier:
NCT00009633
First received: February 1, 2001
Last updated: June 3, 2015
Last verified: June 2015
  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 NICHD Neonatal Research Network:

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   (Child)
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

  Show 29 Study Locations
Sponsors and Collaborators
NICHD Neonatal Research Network
National Center for Research Resources (NCRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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: C. Michael Cotten, MD, MHS Duke University
Principal Investigator: Barbara J. Stoll, MD Emory University
Principal Investigator: Greg Sokol, MD 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 Children's Hospital Medical Center, Cincinnati
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: Myra H Wyckoff, 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
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: NICHD Neonatal Research Network
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: June 3, 2015
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by NICHD Neonatal Research Network:
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 August 22, 2016