Generic Database of Very Low Birth Weight Infants



Status:Recruiting
Conditions:Obesity Weight Loss, Women's Studies
Therapuetic Areas:Endocrinology, Reproductive
Healthy:No
Age Range:Any
Updated:8/24/2018
Start Date:January 1987
End Date:March 2021
Contact:Edward F Bell, MD
Phone:319-356-4006

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Generic Database: A Survey of Morbidity and Mortality in Very Low Birth Weight Infants

The Generic Database (GDB) is a registry of very low birth weight infants born alive in NICHD
Neonatal Research Network (NRN) centers. The GDB collects observational baseline data on both
mothers and infants, and the therapies used and outcomes of the infants. The information
collected is not specific to a disease or treatment (i.e., it is "generic"). Data are
analyzed to find associations and trends between baseline information, treatments, and infant
outcome, and to develop future NRN trials.

The Generic Database (GDB) is a registry of very low birth weight infants born alive in NICHD
Neonatal Research Network (NRN) centers. The purpose is to collect baseline and outcome data
in a uniform manner on a large cohort of VLBW and other sick infants admitted to neonatal
intensive care units.

The GDB collects observational baseline data on both mothers and infants, and the therapies
used and outcomes of the infants. The information collected is not specific to a disease or
treatment (i.e., it is "generic"). Baseline data is collected soon after admission to the
NICU; outcome data is collected at the time of death or discharge from the hospital. The data
collected includes information on:

- Demographics of mother and infant

- Mother's health (e.g., pregnancy history and complications)

- Labor and deliver (e.g., rupture of the membranes, steroids and antibiotics given, mode
of delivery)

- Infant's health (gestational age, Apgar scores, weight, length, delivery room
resuscitation, respiratory support, etc.)

- Infant's medical outcome (heart, lung, nervous system, gastrointestinal system, hearing,
and vision, known infections, and major malformations/syndromes, and mortality or number
of days hospitalized).

These data are used: to examine associations between baseline characteristics, treatments,
and outcomes; to track trends in incidences of disease and effectiveness of therapies; and to
identify questions requiring additional in-depth research.

Informed Consent: As required by local IRBs.

Secondary Studies include:

A. The All Birth Cohort (ABC) Study. A time-limited observational registry to determine the
incidence of intrapartum stillbirth at 22 0/7 - 28 6/7 weeks' gestation and its associated
factors at Network sites.

Inclusion Criteria:

- Infants inborn at NICHD NRN centers that are:

- 401-1000 grams birth weight, and/or

- 22 0/7 to 28 6/7 weeks (<29 weeks) gestational age

- Infants enrolled in one or more additional NICHD NRN interventional trials or
time-limited observational studies. For infants that do not meet the inclusion
criteria above, inclusion and exclusion criteria for the Generic Database 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 29 weeks may be included in the GDB.

Exclusion Criteria:

- Infants >1,000 grams birth weight and/or >29 weeks gestational age

Note: These inclusion criteria were changed as of 1/1/2008. Prior to this date, all infants
with birth weights between 401 and 1500 grams who are admitted to NRN NICUs within 14 days
of birth were included in the database.
We found this trial at
28
sites
Providence, Rhode Island 02905
Principal Investigator: Abbot R. Laptook, MD
Phone: 401-274-1122
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: David P Carlton, MD
Phone: 404-727-5772
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Waldemar A. Carlo, MD
Phone: 205-934-4680
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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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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Boston, MA
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85 S Prospect St
Burlington, Vermont 5405
(802) 656-3131
University of Vermont The University of Vermont combines faculty-student relationships most commonly found in a...
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1350 Massachusetts Avenue
Cambridge, Massachusetts 02138
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Cambridge, MA
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5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Principal Investigator: Myra H Wyckoff, MD
Phone: 214-590-4003
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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Dallas, TX
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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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Detroit, MI
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3040 East Cornwallis RoadTriangle
Durham, North Carolina 27705
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Durham, NC
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: C. Michael Cotten, MD, MHS
Phone: 919-681-0630
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Principal Investigator: Jon E. Tyson, MD MPH
Phone: 713-500-6708
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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Indianapolis, IN
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Edward F. Bell, MD
Phone: 319-356-4006
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Iowa City, IA
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2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Principal Investigator: William Truog, MD
Phone: 816-234-3592
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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Kansas City, MO
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Los Angeles, California 90095
310-825-4321
Principal Investigator: Uday Devaskar, MD
Phone: 310-825-9314
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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920 Madison Ave
Memphis, Tennessee 38163
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Memphis, TN
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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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Miami, FL
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Carl T D'Angio, MD
Phone: 585-273-4911
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Rochester, NY
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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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Salt Lake City, UT
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Albuquerque, New Mexico 87131
(505) 277-0111
Principal Investigator: Kristi L. Watterberg, MD
Phone: 505-272-8609
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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Cincinnati, Ohio 45267
Principal Investigator: Brenda Poindexter, MD MS
Phone: 513-636-3972
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Cincinnati, OH
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Cleveland, Ohio 44106
Principal Investigator: Michele C. Walsh, MD MS
Phone: 216-844-3387
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Cleveland, OH
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Columbus, Ohio 43205
Principal Investigator: Leif Nelin, MD
Phone: 614-355-6724
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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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New Haven, CT
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Palo Alto, California 94304
Principal Investigator: Krisa P. Van Meurs, MD
Phone: 650-723-5711
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Philadelphia, Pennsylvania 19104
Principal Investigator: Eric Eichenwald, MD
Phone: 215-662-3228
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Philadelphia, PA
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San Diego, California 92093
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Washington, District of Columbia 20052
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