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Generic Database of Very Low Birth Weight Infants (GDB)

This study is currently recruiting participants.
Verified by National Institute of Child Health and Human Development (NICHD), June 2008

Sponsored by: National Institute of Child Health and Human Development (NICHD)
Information provided by: National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00063063
  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

U.S. FDA Resources

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

Further study details as provided by 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 ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   68000
Study Start Date:   January 1987
Estimated Study Completion Date:   March 2011
Estimated Primary Completion Date:   March 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
1
All infants included in the database.

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    

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) 934-5771     mcollins@peds.uab.edu    
      Principal Investigator: Waldemar A. Carlo, MD            
United States, California
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            
United States, Connecticut
Yale University     Recruiting
      New Haven, Connecticut, United States, 06504
      Contact: Richard A. Ehrenkranz, MD     203-688-2895     richard.ehrenkranz@yale.edu    
      Contact: Monica Konstantino, RN BSN     (203) 688-7987     monica.konstantino@yale.edu    
      Principal Investigator: Richard A. Ehrenkranz, MD            
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            
      Sub-Investigator: Shannon Hamrick, MD            
United States, Indiana
Indiana University     Recruiting
      Indianapolis, Indiana, United States, 46202
      Contact: Brenda B. Poindexter, MD MS     317-274-3592     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     Recruiting
      Boston, Massachusetts, United States, 02111
      Contact: Ivan D. Frantz III, MD     617-636-5322     ifrantz@tufts-nemc.org    
      Contact: Brenda L. MacKinnon, RNC     (617) 636-1218     bmackinnon@tufts-nemc.org    
      Principal Investigator: Ivan D. Frantz III, MD            
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) 745-1436     rbara@med.wayne.edu    
      Principal Investigator: Seetha Shankaran, MD            
United States, New Mexico
University of New Mexico     Recruiting
      Albuquerque, New Mexico, United States, 87131
      Contact: Kristi L. Watterberg, MD     505-272-3967     kwatterberg@salud.unm.edu    
      Contact: Conra Backstrom Lacy, RN     (505) 272-0367     cbackstrom@salud.unm.edu    
      Principal Investigator: Kristi L. Watterberg, 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: Katherine A. Foy     (919) 668-3360     foy00004@mc.duke.edu    
      Principal Investigator: Ronald N. Goldberg, MD            
RTI International     Recruiting
      Durham, North Carolina, United States, 27705
      Contact: Abhik Das, PhD     301-770-8214     adas@rti.org    
      Contact: Kristin Zaterka-Baxter, RN     (919) 485-7750     kzaterka@rti.org    
      Principal Investigator: Abhik Das, PhD            
United States, Ohio
Case Western Reserve University     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            
University of Cincinnati     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            
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, Texas
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            
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: Nancy A. Miller, RN     (214) 648-3780     Nancy.Miller@UTSouthwestern.edu    
      Principal Investigator: Pablo J. Sanchez, MD            
United States, Utah
University of Utah     Recruiting
      Salt Lake City, Utah, United States, 84108
      Contact: Roger G. Faix, MD     801-581-7052     roger.faix@hsc.utah.edu    
      Contact: Karen A. Osborne, RN BSN     (801) 213-3298     karen.osborne@hsc.utah.edu    
      Principal Investigator: Roger G. Faix, MD            

Sponsors and Collaborators
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    
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     University of Cincinnati    
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:     Roger G Faix, MD     University of Utah    
Principal Investigator:     Seetha Shankaran, MD     Wayne State University    
Principal Investigator:     Richard A Ehrenkranz, MD     Yale University    
  More Information

Home page of the NICHD Neonatal Research Network  This link exits the ClinicalTrials.gov site
 
Home page of the NICHD Pregnancy & Perinatology Branch  This link exits the ClinicalTrials.gov site
 

Publications of Results:
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.
 
Cotten CM, McDonald S, Stoll B, Goldberg RN, Poole K, Benjamin DK Jr; National Institute for Child Health and Human Development Neonatal Research Network. The association of third-generation cephalosporin use and invasive candidiasis in extremely low birth-weight infants. Pediatrics. 2006 Aug;118(2):717-22.
 
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.
 
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.
 
Ehrenkranz RA, Dusick AM, Vohr BR, Wright LL, Wrage LA, Poole WK. Growth in the neonatal intensive care unit influences neurodevelopmental and growth outcomes of extremely low birth weight infants. Pediatrics. 2006 Apr;117(4):1253-61.
 
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.
 
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, Korones SB, Wright LL, Verter J, Poland RL, Bauer CR, Tyson JE, Philips JB 3rd, Edwards W, Lucey JF, Catz CS, Shankaran S, Oh W. Incidence, presenting features, risk factors and significance of late onset septicemia in very low birth weight infants. The National Institute of Child Health and Human Development Neonatal Research Network. Pediatr Infect Dis J. 1998 Jul;17(7):593-8.
 
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.
 
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.
 
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.
 
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.
 
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.
 
Lee BH, Stoll BJ, McDonald SA, Higgins RD; National Institute of Child Health and Human Development Neonatal Research Network. Adverse neonatal outcomes associated with antenatal dexamethasone versus antenatal betamethasone. Pediatrics. 2006 May;117(5):1503-10.
 
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.
 
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.
 
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.
 
Oh W, Poindexter BB, Perritt R, Lemons JA, Bauer CR, Ehrenkranz RA, Stoll BJ, Poole K, Wright LL; Neonatal Research Network. Association between fluid intake and weight loss during the first ten days of life and risk of bronchopulmonary dysplasia in extremely low birth weight infants. J Pediatr. 2005 Dec;147(6):786-90.
 
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.
 
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.
 
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.
 
Stevenson DK, Wright LL, Lemons JA, Oh W, Korones SB, Papile LA, Bauer CR, Stoll BJ, Tyson JE, Shankaran S, Fanaroff AA, Donovan EF, Ehrenkranz RA, Verter J. Very low birth weight outcomes of the National Institute of Child Health and Human Development Neonatal Research Network, January 1993 through December 1994. Am J Obstet Gynecol. 1998 Dec;179(6 Pt 1):1632-9.
 
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. Early-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):72-80.
 
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, 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.
 
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. Late-onset sepsis in very low birth weight neonates: the experience of the NICHD Neonatal Research Network. Pediatrics. 2002 Aug;110(2 Pt 1):285-91.
 
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, 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 NI, Higgins RD, Fanaroff AA, Duara S, Goldberg R, Laptook A, Walsh M, Oh W, Hale E; National Institute of Child Health and Human Development. Very low birth weight preterm infants with early onset neonatal sepsis: the predominance of gram-negative infections continues in the National Institute of Child Health and Human Development Neonatal Research Network, 2002-2003. Pediatr Infect Dis J. 2005 Jul;24(7):635-9.
 
Tyson JE, Younes N, Verter J, Wright LL. Viability, morbidity, and resource use among newborns of 501- to 800-g birth weight. National Institute of Child Health and Human Development Neonatal Research Network. JAMA. 1996 Nov 27;276(20):1645-51.
 
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.
 
Wadhawan R, Oh W, Perritt R, Laptook AR, Poole K, Wright LL, Fanaroff AA, Duara S, Stoll BJ, Goldberg R. Association between early postnatal weight loss and death or BPD in small and appropriate for gestational age extremely low-birth-weight infants. J Perinatol. 2007 Jun;27(6):359-64. Epub 2007 Apr 19.
 

Publications indexed to this study:
Tyson JE, Parikh NA, Langer J, Green C, Higgins RD; National Institute of Child Health and Human Development Neonatal Research Network. Intensive care for extreme prematurity--moving beyond gestational age. N Engl J Med. 2008 Apr 17;358(16):1672-81.
 

Responsible Party:   Emory University ( Barbara J. Stoll, Principal Investigator )
Study ID Numbers:   NICHD-NRN-0001, U01 HD36790 (RTI), U10 HD21364 (Case), U10 HD21373 (UT Houston), U10 HD21385 (Wayne State), U10 HD27851 (Emory), U10 HD27853 (Cincinnati), U10 HD27856 (Indiana), U10 HD27871 (Yale), U10 HD27880 (Stanford), U10 HD27904 (Brown), U10 HD34216 (Alabama), U10 HD40492 (Duke), U10 HD40689 (UT Dallas), U10 HD53089 (New Mexico), U10 HD53109 (Iowa), U10 HD53119 (Tufts), U10 HD53124 (Utah), CCTS KL2 RR24149 (Houston), CCTS UL1 RR24128 (Duke), CCTS UL1 RR24139 (Yale), CCTS UL1 RR24148 (Houston), CCTS UL1 RR24979 (Iowa), CCTS UL1 RR24982 (Dallas), CCTS UL1 RR24989 (Case), CCTS UL1 RR25008 (Emory), GCRC M01 RR30 (Duke), GCRC M01 RR633 (Dallas), GCRC M01 RR64 (Utah), GCRC M01 RR70 (Stanford), GCRC M01 RR750 (Indiana), GCRC M01 RR80 (Case), GCRC M01 RR8084 (Cincinnati)
First Received:   June 19, 2003
Last Updated:   June 20, 2008
ClinicalTrials.gov Identifier:   NCT00063063
Health Authority:   United States: Federal Government;   United States: Institutional Review Board

Keywords provided by National Institute of Child Health and Human Development (NICHD):
NICHD Neonatal Research Network  
Extremely Low Birth Weight (ELBW)  
Prematurity  

Study placed in the following topic categories:
Body Weight
Birth Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 05, 2008

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