Follow-up Visit of High Risk Infants (FU)

This study is currently recruiting participants.
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

February 1, 2001
July 19, 2013
January 1993
March 2016   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00009633 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Follow-up Visit of High Risk Infants
Follow-up Visit of High Risk Infants

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

  • Infant, Newborn
  • Infant, Low Birth Weight
  • Infant, Small for Gestational Age
  • Infant, Premature
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
68000
March 2016
March 2016   (final data collection date for primary outcome measure)
  • 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.

Both
18 Months to 26 Months
No
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
United States
 
NCT00009633
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
No
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Center for Research Resources (NCRR)
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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP