Generic Database of Very Low Birth Weight Infants (GDB)

This study is currently recruiting participants.

Verified January 2013 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Sponsor:

Collaborator:

National Center for Research Resources (NCRR)

Information provided by (Responsible Party):

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

ClinicalTrials.gov Identifier:

NCT00063063

First received: June 19, 2003

Last updated: January 14, 2013

Last verified: January 2013

History of Changes

Purpose

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.

Condition
Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Generic Database: A Survey of Morbidity and Mortality in Very Low Birth Weight Infants

Resource links provided by NLM:

MedlinePlus related topics: Birth Weight Premature Babies

U.S. FDA Resources

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

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 3/31/2011 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To examine the relationship between baseline characteristics and outcome [ Time Frame: Longitudinal database currently funded through 3/31/2011 ] [ Designated as safety issue: No ]
To monitor trends in incidence of various disease entities [ Time Frame: Longitudinal database currently funded through 3/31/2011 ] [ Designated as safety issue: No ]
To monitor changes in VLBW and early gestational age survival [ Time Frame: Longitudinal database currently funded through 3/31/2011 ] [ 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 3/31/2011 ] [ Designated as safety issue: No ]

Estimated Enrollment:	80000
Study Start Date:	January 1987
Estimated Study Completion Date:	March 2016
Estimated Primary Completion Date:	March 2016 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	up to 14 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Infants inborn at NICHD NRN centers that are 401-1000 grams birth weight, and/or <29 weeks gestational age, OR infants enrolled in one or more additional NICHD NRN studies.

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00063063

Contacts

Contact: Barbara J Stoll, MD	(404) 727-2456	barbara_stoll@oz.ped.emory.edu
Contact: Rosemary D Higgins, MD	(301) 435-7909	higginsr@mail.nih.gov

Hide Study Locations

Locations

United States, Alabama
University of Alabama at Birmingham	Recruiting
Birmingham, Alabama, United States, 35233
Contact: Waldemar A. Carlo, MD 205-934-4680 wcarlo@peds.uab.edu
Contact: Monica V. Collins, RN BSN (205) 934-4680 mcollins@peds.uab.edu
Principal Investigator: Waldemar A. Carlo, MD
United States, California
University of California - Los Angeles	Recruiting
Los Angeles, California, United States, 90025
Contact: Uday Devaskar, MD 310-825-9357 udevaskar@mednet.ucla.edu
Contact: Teresa Chanlaw, BS (310) 794-4972 tchanlaw@mednet.ucla.edu
Principal Investigator: Uday Devaskar, MD
Sub-Investigator: James Dunn, MD, PhD
University of California - Los Angeles	Recruiting
Los Angeles, California, United States, 90025
Contact: Uday Devaskar, MD 310-825-9357 udevaskar@mednet.ucla.edu
Contact: Teresa Chanlaw, BS (310) 794-4972 tchanlaw@mednet.ucla.edu
Principal Investigator: Uday Devaskar, MD
Stanford University	Recruiting
Palo Alto, California, United States, 94304
Contact: Krisa P. Van Meurs, MD 650-723-5711 vanmeurs@leland.stanford.edu
Contact: M. Bethany Ball, BS CCRC (650) 725-8342 mbball@stanford.edu
Principal Investigator: Krisa P. Van Meurs, MD
University of California at San Diego	Completed
San Diego, California, United States, 92103-8774
United States, Connecticut
Yale University	Completed
New Haven, Connecticut, United States, 06504
United States, District of Columbia
George Washington University	Completed
Washington, District of Columbia, United States, 20052
United States, Florida
University of Miami	Completed
Miami, Florida, United States, 33136
United States, Georgia
Emory University	Recruiting
Atlanta, Georgia, United States, 30303
Contact: Barbara J. Stoll, MD 404-727-5740 barbara_stoll@oz.ped.emory.edu
Contact: Ellen Hale, RN BS (404) 616-4218 ellen_hale@oz.ped.emory.edu
Principal Investigator: Barbara J. Stoll, MD
United States, Indiana
Indiana University	Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Brenda B. Poindexter, MD MS 317-274-4768 bpoindex@iupui.edu
Contact: Leslie D. Wilson, RN BSN (317) 274-8255 ldw@iupui.edu
Principal Investigator: Brenda B. Poindexter, MD MS
United States, Iowa
University of Iowa	Recruiting
Iowa City, Iowa, United States, 52242
Contact: Edward F. Bell, MD 319-356-4006 edward-bell@uiowa.edu
Contact: Karen J. Johnson, RN BSN (319) 356-2924 karen-johnson@uiowa.edu
Principal Investigator: Edward F. Bell, MD
United States, Massachusetts
Tufts Medical Center	Completed
Boston, Massachusetts, United States, 02111
Harvard University	Completed
Cambridge, Massachusetts, United States, 02138
United States, Michigan
Wayne State University	Recruiting
Detroit, Michigan, United States, 48201
Contact: Seetha Shankaran, MD 313-745-1436 sshankar@med.wayne.edu
Contact: Rebecca Bara, RN BSN (313) 993-7216 rbara@med.wayne.edu
Principal Investigator: Seetha Shankaran, MD
United States, Missouri
Children's Mercy Hospital	Recruiting
Kansas City, Missouri, United States, 64108
Contact: William Truog, MD 816-234-3592 wtruog@cmh.edu
Contact: Cheri Gauldin, BSN (816) 234-3920 cagauldin@cmh.edu
Principal Investigator: William Truog, MD
Children's Mercy Hospital	Recruiting
Kansas City, Missouri, United States, 64108
Contact: William Truog, MD 816-234-3592 wtruog@cmh.edu
Contact: Cheri Gauldin, BSN (816) 234-3920 cagauldin@cmh.edu
Principal Investigator: William Truog, MD
Sub-Investigator: George Holcomb, MD
United States, New Mexico
University of New Mexico	Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Kristi L. Watterberg, MD 505-272-0180 kwatterberg@salud.unm.edu
Contact: Conra Backstrom Lacy, RN (505) 272-0367 cbackstrom@salud.unm.edu
Principal Investigator: Kristi L. Watterberg, MD
United States, New York
University of Rochester	Recruiting
Rochester, New York, United States, 14642
Contact: Carl T D'Angio, MD 585-273-4911 carl_dangio@urmc.rochester.edu
Principal Investigator: Carl T D'Angio, MD
University of Rochester	Recruiting
Rochester, New York, United States, 14642
Contact: Carl T D'Angio, MD 585-273-4911 carl_dangio@urmc.rochester.edu
Principal Investigator: Carl T D'Angio, MD
Sub-Investigator: Walter Pegoli, MD
United States, North Carolina
Duke University	Recruiting
Durham, North Carolina, United States, 27710
Contact: Ronald N. Goldberg, MD 919-681-6025 goldb008@mc.duke.edu
Contact: Kimberly A. Fisher, PhD (919) 681-4913 kimberley.fisher@duke.edu
Principal Investigator: Ronald N. Goldberg, MD
RTI International	Active, not recruiting
Durham, North Carolina, United States, 27705
United States, Ohio
Cincinnati Children's Medical Center	Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Kurt Schibler, MD 513-636-3972 kurt.schibler@cchmc.org
Contact: Cathy Grisby, BSN CCRC (513) 558-4953 grisbyca@email.uc.edu
Principal Investigator: Kurt Schibler, MD
Case Western Reserve University, Rainbow Babies and Children's Hospital	Recruiting
Cleveland, Ohio, United States, 44106
Contact: Michele C. Walsh, MD MS 216-844-3759 mcw3@cwru.edu
Contact: Nancy S. Newman, BA RN (216) 368-3084 nxs5@cwru.edu
Principal Investigator: Michele C. Walsh, MD MS
Research Institute at Nationwide Children's Hospital	Recruiting
Columbus, Ohio, United States, 43205
Contact: Leif Nelin, MD 614-722-3030 Leif.Nelin@nationwidechildrens.org
Contact: Christine Fortney, MS, RN 614-722-6489 christine.fortney@nationwidechildrens.org
Principal Investigator: Leif Nelin, MD
Research Institute at Nationwide Children's Hospital	Recruiting
Columbus, Ohio, United States, 43205
Contact: Leif Nelin, MD 614-722-3030 Leif.Nelin@nationwidechildrens.org
Contact: Christine Fortney, MS, RN 614-722-6489 christine.fortney@nationwidechildrens.org
Principal Investigator: Leif Nelin, MD
Sub-Investigator: Gail E Besner, MD
United States, Pennsylvania
Univeristy of Pennsylvania	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Barbara Schmidt, MD 215-662-3228 barbara.schmidt@uphs.upenn.edu
Contact: Aasma Chaudhary, BS 215-615-5442 aasma.chaudhary@uphs.upenn.edu
Principal Investigator: Barbara Schmidt, MD
Univeristy of Pennsylvania	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Barbara Schmidt, MD 215-662-3228 barbara.schmidt@uphs.upenn.edu
Contact: Aasma Chaudhary, BS 215-615-5442 aasma.chaudhary@uphs.upenn.edu
Principal Investigator: Barbara Schmidt, MD
Sub-Investigator: Alan Flake, MD
United States, Rhode Island
Brown University, Women & Infants Hospital of Rhode Island	Recruiting
Providence, Rhode Island, United States, 02905
Contact: Abbot R. Laptook, MD 401-274-1122 alaptook@WIHRI.org
Contact: Angelita Hensman (401) 274-1122 ahensman@wihri.org
Principal Investigator: Abbot R. Laptook, MD
United States, Tennessee
University of Tennessee	Completed
Memphis, Tennessee, United States, 38163
United States, Texas
University of Texas Southwestern Medical Center at Dallas	Recruiting
Dallas, Texas, United States, 75235
Contact: Pablo J. Sanchez, MD 214-648-3753 Pablo.Sanchez@UTSouthwestern.edu
Contact: Diana M. Vasil, RNC-NIC (214) 648-3789 Diana.Vasil@utsouthwestern.edu
Principal Investigator: Pablo J. Sanchez, MD
University of Texas Health Science Center at Houston	Recruiting
Houston, Texas, United States, 77030
Contact: Kathleen A. Kennedy, MD MPH 713-500-6708 Kathleen.A.Kennedy@uth.tmc.edu
Contact: Georgia E. McDavid, RN (713) 500-5734 Georgia.E.McDavid@uth.tmc.edu
Principal Investigator: Kathleen A. Kennedy, MD MPH
United States, Utah
University of Utah	Completed
Salt Lake City, Utah, United States, 84108
United States, Vermont
University of Vermont	Completed
Burlington, Vermont, United States, 05405

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Center for Research Resources (NCRR)

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:	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:	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
Study Director:	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:	Seetha Shankaran, MD	Wayne State University
Principal Investigator:	William Truog, MD	Children's Mercy Hospital-Kansas City, MO
Principal Investigator:	Barbara Schmidt, MD, MSc	University of Pennsylvania
Principal Investigator:	Carl D'Angio, MD	University of Rochester
Principal Investigator:	Uday Devaskar, MD	University of California, Los Angeles
Principal Investigator:	Leif Nelin, MD	Research Institute at Nationwide Children's Hospital

More Information

Additional Information:

NICHD Neonatal Research Network This link exits the ClinicalTrials.gov site

NICHD Pregnancy & Perinatology Branch This link exits the ClinicalTrials.gov site

Publications:

Adams-Chapman I, Hansen NI, Stoll BJ, Higgins R; NICHD Research Network. Neurodevelopmental outcome of extremely low birth weight infants with posthemorrhagic hydrocephalus requiring shunt insertion. Pediatrics. 2008 May;121(5):e1167-77. Epub 2008 Apr 7.

Ambalavanan N, Carlo WA, Bobashev G, Mathias E, Liu B, Poole K, Fanaroff AA, Stoll BJ, Ehrenkranz R, Wright LL; National Institute of Child Health and Human Development Neonatal Research Network. Prediction of death for extremely low birth weight neonates. Pediatrics. 2005 Dec;116(6):1367-73.

Benjamin DK Jr, Stoll BJ, Fanaroff AA, McDonald SA, Oh W, Higgins RD, Duara S, Poole K, Laptook A, Goldberg R; National Institute of Child Health and Human Development Neonatal Research Network. Neonatal candidiasis among extremely low birth weight infants: risk factors, mortality rates, and neurodevelopmental outcomes at 18 to 22 months. Pediatrics. 2006 Jan;117(1):84-92.

Broitman E, Ambalavanan N, Higgins RD, Vohr BR, Das A, Bhaskar B, Murray K, Hintz SR, Carlo WA; National Institute of Child Health and Human Development Neonatal Research Network. Clinical data predict neurodevelopmental outcome better than head ultrasound in extremely low birth weight infants. J Pediatr. 2007 Nov;151(5):500-5, 505.e1-2. Epub 2007 Jul 12.

Castro L, Yolton K, Haberman B, Roberto N, Hansen NI, Ambalavanan N, Vohr BR, Donovan EF. Bias in reported neurodevelopmental outcomes among extremely low birth weight survivors. Pediatrics. 2004 Aug;114(2):404-10.

Cole CR, Hansen NI, Higgins RD, Ziegler TR, Stoll BJ; Eunice Kennedy Shriver NICHD Neonatal Research Network. Very low birth weight preterm infants with surgical short bowel syndrome: incidence, morbidity and mortality, and growth outcomes at 18 to 22 months. Pediatrics. 2008 Sep;122(3):e573-82.

Michael Cotten C, Oh W, McDonald S, Carlo W, Fanaroff AA, Duara S, Stoll B, Laptook A, Poole K, Wright LL, Goldberg RN; NICHD Neonatal Research Network. Prolonged hospital stay for extremely premature infants: risk factors, center differences, and the impact of mortality on selecting a best-performing center. J Perinatol. 2005 Oct;25(10):650-5.

Cotten CM, Taylor S, Stoll B, Goldberg RN, Hansen NI, Sánchez PJ, Ambalavanan N, Benjamin DK Jr; NICHD Neonatal Research Network. Prolonged duration of initial empirical antibiotic treatment is associated with increased rates of necrotizing enterocolitis and death for extremely low birth weight infants. Pediatrics. 2009 Jan;123(1):58-66.

Da Costa D, Bann CM, Hansen NI, Shankaran S, Delaney-Black V; National Institute of Child Health and Human Development Neonatal Research Network. Validation of the Functional Status II questionnaire in the assessment of extremely-low-birthweight infants. Dev Med Child Neurol. 2009 Jul;51(7):536-44.

Demarini S, Dollberg S, Hoath SB, Ho M, Donovan EF. Effects of antenatal corticosteroids on blood pressure in very low birth weight infants during the first 24 hours of life. J Perinatol. 1999 Sep;19(6 Pt 1):419-25.

Dollberg S, Demarini S, Donovan EF, Hoath SB. Maturation of thermal capabilities in preterm infants. Am J Perinatol. 2000;17(1):47-51.

Donovan EF, Ehrenkranz RA, Shankaran S, Stevenson DK, Wright LL, Younes N, Fanaroff AA, Korones SB, Stoll BJ, Tyson JE, Bauer CR, Lemons JA, Oh W, Papile LA. Outcomes of very low birth weight twins cared for in the National Institute of Child Health and Human Development Neonatal Research Network's intensive care units. Am J Obstet Gynecol. 1998 Sep;179(3 Pt 1):742-9.

Doyle NM, Gardner MO, Wells L, Qualls C, Papile LA. Outcome of very low birth weight infants exposed to antenatal indomethacin for tocolysis. J Perinatol. 2005 May;25(5):336-40.

Ehrenkranz RA, Walsh MC, Vohr BR, Jobe AH, Wright LL, Fanaroff AA, Wrage LA, Poole K; National Institutes of Child Health and Human Development Neonatal Research Network. Validation of the National Institutes of Health consensus definition of bronchopulmonary dysplasia. Pediatrics. 2005 Dec;116(6):1353-60.

Ehrenkranz RA, Wright LL. NICHD neonatal research network: contributions and future challenges. Semin Perinatol. 2003 Aug;27(4):264-80. Review.

Fanaroff AA, Hack M, Walsh MC. The NICHD neonatal research network: changes in practice and outcomes during the first 15 years. Semin Perinatol. 2003 Aug;27(4):281-7.

Fanaroff AA, Stoll BJ, Wright LL, Carlo WA, Ehrenkranz RA, Stark AR, Bauer CR, Donovan EF, Korones SB, Laptook AR, Lemons JA, Oh W, Papile LA, Shankaran S, Stevenson DK, Tyson JE, Poole WK; NICHD Neonatal Research Network. Trends in neonatal morbidity and mortality for very low birthweight infants. Am J Obstet Gynecol. 2007 Feb;196(2):147.e1-8.

Fanaroff AA, Wright LL, Stevenson DK, Shankaran S, Donovan EF, Ehrenkranz RA, Younes N, Korones SB, Stoll BJ, Tyson JE, et al. Very-low-birth-weight outcomes of the National Institute of Child Health and Human Development Neonatal Research Network, May 1991 through December 1992. Am J Obstet Gynecol. 1995 Nov;173(5):1423-31.

Gardner MO, Papile LA, Wright LL. Antenatal corticosteroids in pregnancies complicated by preterm premature rupture of membranes. Obstet Gynecol. 1997 Nov;90(5):851-3.

Gargus RA, Vohr BR, Tyson JE, High P, Higgins RD, Wrage LA, Poole K. Unimpaired outcomes for extremely low birth weight infants at 18 to 22 months. Pediatrics. 2009 Jul;124(1):112-21.

Guillet R, Stoll BJ, Cotten CM, Gantz M, McDonald S, Poole WK, Phelps DL; National Institute of Child Health and Human Development Neonatal Research Network. Association of H2-blocker therapy and higher incidence of necrotizing enterocolitis in very low birth weight infants. Pediatrics. 2006 Feb;117(2):e137-42. Epub 2006 Jan 3.

Hack M, Horbar JD, Malloy MH, Tyson JE, Wright E, Wright L. Very low birth weight outcomes of the National Institute of Child Health and Human Development Neonatal Network. Pediatrics. 1991 May;87(5):587-97.

Hack M, Wright LL, Shankaran S, Tyson JE, Horbar JD, Bauer CR, Younes N. Very-low-birth-weight outcomes of the National Institute of Child Health and Human Development Neonatal Network, November 1989 to October 1990. Am J Obstet Gynecol. 1995 Feb;172(2 Pt 1):457-64. Erratum in: Am J Obstet Gynecol 1995 Sep;173(3 Pt 1):961.

Heller CD, O'Shea M, Yao Q, Langer J, Ehrenkranz RA, Phelps DL, Poole WK, Stoll B, Duara S, Oh W, Lemons J, Poindexter B; NICHD Neonatal Research Network. Human milk intake and retinopathy of prematurity in extremely low birth weight infants. Pediatrics. 2007 Jul;120(1):1-9.

Hintz SR, Kendrick DE, Vohr BR, Poole WK, Higgins RD; National Institute of Child Health and Human Development (NICHD) Neonatal Research Network. Community supports after surviving extremely low-birth-weight, extremely preterm birth: special outpatient services in early childhood. Arch Pediatr Adolesc Med. 2008 Aug;162(8):748-55.

Hintz SR, Bann CM, Ambalavanan N, Cotten CM, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Predicting time to hospital discharge for extremely preterm infants. Pediatrics. 2010 Jan;125(1):e146-54. Epub 2009 Dec 14.

Hintz SR, Kendrick DE, Stoll BJ, Vohr BR, Fanaroff AA, Donovan EF, Poole WK, Blakely ML, Wright L, Higgins R; NICHD Neonatal Research Network. Neurodevelopmental and growth outcomes of extremely low birth weight infants after necrotizing enterocolitis. Pediatrics. 2005 Mar;115(3):696-703.

Hintz SR, Kendrick DE, Vohr BR, Poole WK, Higgins RD; National Institute of Child Health and Human Development Neonatal Research Network. Changes in neurodevelopmental outcomes at 18 to 22 months' corrected age among infants of less than 25 weeks' gestational age born in 1993-1999. Pediatrics. 2005 Jun;115(6):1645-51.

Hintz SR, Kendrick DE, Vohr BR, Kenneth Poole W, Higgins RD, For The Nichd Neonatal Research Network. Gender differences in neurodevelopmental outcomes among extremely preterm, extremely-low-birthweight infants. Acta Paediatr. 2006 Oct;95(10):1239-48.

Hintz SR, Poole WK, Wright LL, Fanaroff AA, Kendrick DE, Laptook AR, Goldberg R, Duara S, Stoll BJ, Oh W; NICHD Neonatal Research Network. Changes in mortality and morbidities among infants born at less than 25 weeks during the post-surfactant era. Arch Dis Child Fetal Neonatal Ed. 2005 Mar;90(2):F128-33.

Horbar JD, Onstad L, Wright E. Predicting mortality risk for infants weighing 501 to 1500 grams at birth: a National Institutes of Health Neonatal Research Network report. Crit Care Med. 1993 Jan;21(1):12-8.

Horbar JD, Wright EC, Onstad L. Decreasing mortality associated with the introduction of surfactant therapy: an observational study of neonates weighing 601 to 1300 grams at birth. The Members of the National Institute of Child Health and Human Development Neonatal Research Network. Pediatrics. 1993 Aug;92(2):191-6.

Lainwala S, Perritt R, Poole K, Vohr B; National Institute of Child Health and Human Development Neonatal Research Network. Neurodevelopmental and growth outcomes of extremely low birth weight infants who are transferred from neonatal intensive care units to level I or II nurseries. Pediatrics. 2007 May;119(5):e1079-87. Epub 2007 Apr 2.

Laptook AR, O'Shea TM, Shankaran S, Bhaskar B; NICHD Neonatal Network. Adverse neurodevelopmental outcomes among extremely low birth weight infants with a normal head ultrasound: prevalence and antecedents. Pediatrics. 2005 Mar;115(3):673-80.

Laptook AR, Salhab W, Bhaskar B; Neonatal Research Network. Admission temperature of low birth weight infants: predictors and associated morbidities. Pediatrics. 2007 Mar;119(3):e643-9. Epub 2007 Feb 12.

Lemons JA, Bauer CR, Oh W, Korones SB, Papile LA, Stoll BJ, Verter J, Temprosa M, Wright LL, Ehrenkranz RA, Fanaroff AA, Stark A, Carlo W, Tyson JE, Donovan EF, Shankaran S, Stevenson DK. Very low birth weight outcomes of the National Institute of Child health and human development neonatal research network, January 1995 through December 1996. NICHD Neonatal Research Network. Pediatrics. 2001 Jan;107(1):E1.

Lowe J, Woodward B, Papile LA. Emotional regulation and its impact on development in extremely low birth weight infants. J Dev Behav Pediatr. 2005 Jun;26(3):209-13.

Madan JC, Kendrick D, Hagadorn JI, Frantz ID 3rd; National Institute of Child Health and Human Development Neonatal Research Network. Patent ductus arteriosus therapy: impact on neonatal and 18-month outcome. Pediatrics. 2009 Feb;123(2):674-81.

Malcolm WF, Gantz M, Martin RJ, Goldstein RF, Goldberg RN, Cotten CM; National Institute of Child Health and Human Development Neonatal Research Network. Use of medications for gastroesophageal reflux at discharge among extremely low birth weight infants. Pediatrics. 2008 Jan;121(1):22-7.

Malloy MH, Onstad L, Wright E. The effect of cesarean delivery on birth outcome in very low birth weight infants. National Institute of Child Health and Human Development Neonatal Research Network. Obstet Gynecol. 1991 Apr;77(4):498-503.

Morris BH, Gard CC, Kennedy K; NICHD Neonatal Research Network. Rehospitalization of extremely low birth weight (ELBW) infants: are there racial/ethnic disparities? J Perinatol. 2005 Oct;25(10):656-63.

Oh W, Tyson JE, Fanaroff AA, Vohr BR, Perritt R, Stoll BJ, Ehrenkranz RA, Carlo WA, Shankaran S, Poole K, Wright LL; National Institute of Child Health and Human Development Neonatal Research Network. Association between peak serum bilirubin and neurodevelopmental outcomes in extremely low birth weight infants. Pediatrics. 2003 Oct;112(4):773-9.

Shankaran S, Bauer CR, Bain R, Wright LL, Zachary J. Prenatal and perinatal risk and protective factors for neonatal intracranial hemorrhage. National Institute of Child Health and Human Development Neonatal Research Network. Arch Pediatr Adolesc Med. 1996 May;150(5):491-7.

Shankaran S, Bauer CR, Bain R, Wright LL, Zachary J. Relationship between antenatal steroid administration and grades III and IV intracranial hemorrhage in low birth weight infants. The NICHD Neonatal Research Network. Am J Obstet Gynecol. 1995 Jul;173(1):305-12. No abstract available.

Shankaran S, Johnson Y, Langer JC, Vohr BR, Fanaroff AA, Wright LL, Poole WK. Outcome of extremely-low-birth-weight infants at highest risk: gestational age < or =24 weeks, birth weight < or =750 g, and 1-minute Apgar < or =3. Am J Obstet Gynecol. 2004 Oct;191(4):1084-91.

Shankaran S, Fanaroff AA, Wright LL, Stevenson DK, Donovan EF, Ehrenkranz RA, Langer JC, Korones SB, Stoll BJ, Tyson JE, Bauer CR, Lemons JA, Oh W, Papile LA. Risk factors for early death among extremely low-birth-weight infants. Am J Obstet Gynecol. 2002 Apr;186(4):796-802.

St John EB, Carlo WA. Respiratory distress syndrome in VLBW infants: changes in management and outcomes observed by the NICHD Neonatal Research Network. Semin Perinatol. 2003 Aug;27(4):288-92.

Stephens BE, Bann CM, Poole WK, Vohr BR. NEURODEVELOPMENTAL IMPAIRMENT: PREDICTORS OF ITS IMPACT ON THE FAMILIES OF EXTREMELY LOW BIRTH WEIGHT INFANTS AT 18 MONTHS. Infant Ment Health J. 2008 Nov 1;29(6):570-587.

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Stoll BJ, Gordon T, Korones SB, Shankaran S, Tyson JE, Bauer CR, Fanaroff AA, Lemons JA, Donovan EF, Oh W, Stevenson DK, Ehrenkranz RA, Papile LA, Verter J, Wright LL. Late-onset sepsis in very low birth weight neonates: a report from the National Institute of Child Health and Human Development Neonatal Research Network. J Pediatr. 1996 Jul;129(1):63-71.

Stoll BJ, Hansen N. Infections in VLBW infants: studies from the NICHD Neonatal Research Network. Semin Perinatol. 2003 Aug;27(4):293-301. Review.

Stoll BJ, Hansen N, Fanaroff AA, Lemons JA. Enterobacter sakazakii is a rare cause of neonatal septicemia or meningitis in VLBW infants. J Pediatr. 2004 Jun;144(6):821-3.

Stoll BJ, Hansen N, Fanaroff AA, Wright LL, Carlo WA, Ehrenkranz RA, Lemons JA, Donovan EF, Stark AR, Tyson JE, Oh W, Bauer CR, Korones SB, Shankaran S, Laptook AR, Stevenson DK, Papile LA, Poole WK. To tap or not to tap: high likelihood of meningitis without sepsis among very low birth weight infants. Pediatrics. 2004 May;113(5):1181-6.

Stoll BJ, Hansen N, Fanaroff AA, Wright LL, Carlo WA, Ehrenkranz RA, Lemons JA, Donovan EF, Stark AR, Tyson JE, Oh W, Bauer CR, Korones SB, Shankaran S, Laptook AR, Stevenson DK, Papile LA, Poole WK. Changes in pathogens causing early-onset sepsis in very-low-birth-weight infants. N Engl J Med. 2002 Jul 25;347(4):240-7.

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Vohr BR, Wright LL, Dusick AM, Mele L, Verter J, Steichen JJ, Simon NP, Wilson DC, Broyles S, Bauer CR, Delaney-Black V, Yolton KA, Fleisher BE, Papile LA, Kaplan MD. Neurodevelopmental and functional outcomes of extremely low birth weight infants in the National Institute of Child Health and Human Development Neonatal Research Network, 1993-1994. Pediatrics. 2000 Jun;105(6):1216-26.

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Wadhawan R, Vohr BR, Fanaroff AA, Perritt RL, Duara S, Stoll BJ, Goldberg R, Laptook A, Poole K, Wright LL, Oh W. Does labor influence neonatal and neurodevelopmental outcomes of extremely-low-birth-weight infants who are born by cesarean delivery? Am J Obstet Gynecol. 2003 Aug;189(2):501-6.

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Wright LL. How to develop and manage a successful research network. Semin Pediatr Surg. 2002 Aug;11(3):175-80; discussion 180. No abstract available.

Wright LL, McNellis D. National Institute of Child Health and Human Development (NICHD)-sponsored Perinatal Research Networks. Semin Perinatol. 1995 Apr;19(2):112-23. Review. No abstract available.

Responsible Party:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00063063 History of Changes
Other Study ID Numbers:	NICHD-NRN-0001, 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, M01RR000032, M01RR000039, M01RR000044, M01RR000054, M01RR000059, M01RR000064, M01RR000070, M01RR000080, M01RR000633, M01RR000750, M01RR000997, M01RR008084, M01RR001032, M01RR002172, M01RR002635, M01RR007122, M01RR016587, U10HD068244, U10HD068263, U10HD068270, U10HD068278, U10HD068284
Study First Received:	June 19, 2003
Last Updated:	January 14, 2013
Health Authority:	United States: Federal Government United States: Institutional Review Board

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

NICHD Neonatal Research Network
Extremely Low Birth Weight (ELBW)
Prematurity

Additional relevant MeSH terms:

Birth Weight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013

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