Follow-up Visit of High Risk Infants



Status:Recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:Any
Updated:3/24/2019
Start Date:January 1993
End Date:March 2021
Contact:Susan R Hintz, MD, MS Epi
Email:srhintz@stanford.edu

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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.

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.

- 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.
We found this trial at
29
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920 Madison Ave
Memphis, Tennessee 38163
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: David P. Carlton, MD
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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1350 Massachusetts Avenue
Cambridge, Massachusetts 02138
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5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Principal Investigator: Myra H. Wyckfoff, MD
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Principal Investigator: Seetha Shankaran, MD
Phone: 313-745-1436
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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3040 East Cornwallis RoadTriangle
Durham, North Carolina 27705
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: C. Michael Cotten, MD
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Principal Investigator: Jon E. Tyson, MD MPH
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Greg Sokol, MD
Phone: 317-274-4715
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Edward F. Bell, MD
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Principal Investigator: William Truog, MD
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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Los Angeles, California 90095
310-825-4321
Principal Investigator: Uday Devaskar, MD
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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Providence, Rhode Island 02905
Principal Investigator: Abbot R. Laptook, MD
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Carl T D'Angio, MD
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Bradley Yoder, MD
University of Utah Research is a major component in the life of the U benefiting...
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Albuquerque, New Mexico 87131
(505) 277-0111
Principal Investigator: Kristi L. Watterberg, MD
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Charlotte, North Carolina 27157
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Cincinnati, Ohio 45267
Principal Investigator: Brenda Poindexter, MD
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Cleveland, Ohio 44106
Principal Investigator: Michele C. Walsh, MD MS
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Columbus, Ohio 43205
Principal Investigator: Pablo Sanchez, MD
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New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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Palo Alto, California 94304
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Eric Eichenwald, MD
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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San Diego, California 92093
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Washington, District of Columbia 20052
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