FU: Follow-up Visit of High Risk Infants

Sponsor

NICHD Neonatal Research Network (Other)

Overall Status

Recruiting

CT.gov ID

NCT00009633

Collaborator

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

68,000

Enrollment

Locations

361.9

Duration (Months)

2428.6

Patients Per Site

6.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature

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 Design

Study Type:

Observational

Anticipated Enrollment :

68000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Follow-up Visit of High Risk Infants

Study Start Date :

Jan 1, 1993

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Outcome Measures

Primary Outcome Measures

To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner [Longitudinal database currently funded through 3/31/2016]

Secondary Outcome Measures

To examine the relationship between baseline characteristics and outcome [Longitudinal database currently funded through 3/31/2016]
To provide data for hypothesis formulation and sample size calculation for Network multi-center studies [Longitudinal database currently funded through 3/31/2016]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Months to 26 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35233
2	University of California - Los Angeles	Los Angeles	California	United States	90025
3	Stanford University	Palo Alto	California	United States	94304
4	University of California at San Diego	San Diego	California	United States	92103-8774
5	Yale University	New Haven	Connecticut	United States	06504
6	George Washington University	Washington	District of Columbia	United States	20052
7	University of Miami	Miami	Florida	United States	33136
8	Emory University	Atlanta	Georgia	United States	30303
9	Indiana University	Indianapolis	Indiana	United States	46202
10	University of Iowa	Iowa City	Iowa	United States	52242
11	Tufts Medical Center	Boston	Massachusetts	United States	02111
12	Harvard University	Cambridge	Massachusetts	United States	02138
13	Wayne State University	Detroit	Michigan	United States	48201
14	Children's Mercy Hospital	Kansas City	Missouri	United States	64108
15	University of New Mexico	Albuquerque	New Mexico	United States	87131
16	University of Rochester	Rochester	New York	United States	14642
17	Wake Forest University	Charlotte	North Carolina	United States	27157
18	RTI International	Durham	North Carolina	United States	27705
19	Duke University	Durham	North Carolina	United States	27710
20	Cincinnati Children's Medical Center	Cincinnati	Ohio	United States	45267
21	Case Western Reserve University, Rainbow Babies and Children's Hospital	Cleveland	Ohio	United States	44106
22	Research Institute at Nationwide Children's Hospital	Columbus	Ohio	United States	43205
23	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
24	Brown University, Women & Infants Hospital of Rhode Island	Providence	Rhode Island	United States	02905
25	University of Tennessee	Memphis	Tennessee	United States	38163
26	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas	United States	75235
27	University of Texas Health Science Center at Houston	Houston	Texas	United States	77030
28	University of Utah	Salt Lake City	Utah	United States	84108

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: David P. Carlton, MD, Emory University
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: Brenda B. Poindexter, 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: Jon E Tyson, MD, MPH, The University of Texas Health Science Center, Houston
Principal Investigator: Bradley A. Yoder, MD, University of Utah
Principal Investigator: Seetha Shankaran, MD, Wayne State University
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: Uday Devaskar, MD, University of California, Los Angeles
Principal Investigator: Carl T D'Angio, MD, University of Rochester
Principal Investigator: Eric C Eichenwald, MD, University of Pennsylvania