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RecruitingNCT00063063GDBUpdated Mar 16, 2026

Generic Database of Very Low Birth Weight Infants

An observational study in Infant, Newborn, Infant, Low Birth Weight and Infant, Small for Gestational Age, sponsored by NICHD Neonatal Research Network. Recruiting at 31 sites in United States. Open to participants aged Up to 14 Days. Per ClinicalTrials.gov, last updated 2026-03-16.

Sponsored by NICHD Neonatal Research Network · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80,000
Ages
Up to 14 Days
Sex
All
01

Study summary

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.

Read the 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.

Secondary Studies include:

A. The All Birth Cohort (ABC) Study. A time-limited observational registry to determine the incidence of intrapartum stillbirth at 20 0/7 - 28 6/7 weeks' gestation and its associated factors at Network sites.

02

Conditions studied

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

Browse trials for

Keywords

  • NICHD Neonatal Research Network
  • Extremely Low Birth Weight (ELBW)
  • Prematurity
03

Who can participate

Ages eligible
Up to 14 Days
Sexes eligible
All
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.

Inclusion criteria

  • Infants inborn at NICHD NRN centers that are:
  • 401-1000 grams birth weight, and/or
  • 20 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

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.

04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Registry Cohort

    Registry Cohort

    Other: No Intervention

Interventions

  • OtherNo Intervention
05

What researchers measure

Primary outcomes

  1. To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner

    To maintain a registry of baseline and outcome data for VLBW infants with data collected

    Time frame: Longitudinal database currently funded through 3/31/2030

06

Study locations

13 of 31 sites recruiting
  • University of Alabama at Birmingham
    Birmingham, Alabama 35233, United States
    • Waldemar A. Carlo, MD · Contact
    • Waldemar A. Carlo, MD · Principal investigator
    Recruiting
  • University of California - Los Angeles
    Los Angeles, California 90025, United States
    Completed
  • Stanford University
    Palo Alto, California 94304, United States
    • Krisa P. Van Meurs, MD · Contact
    • Krisa P. Van Meurs, MD · Principal investigator
    Recruiting
  • University of California at San Diego
    San Diego, California 92103-8774, United States
    Completed
  • Sharp Mary Birch Hospital for Women & Newborns
    San Diego, California 92123, United States
    • Anup Katheria, MD · Contact
    • Anup Katheria, MD · Principal investigator
    Recruiting
  • Yale University
    New Haven, Connecticut 06504, United States
    Completed
  • George Washington University
    Washington D.C., District of Columbia 20052, United States
    Completed
  • University of Miami
    Miami, Florida 33136, United States
    Completed
  • Emory University
    Atlanta, Georgia 30303, United States
    • David P Carlton, MD · Contact
    • David P Carlton, MD · Principal investigator
    Recruiting
  • Northwestern Lurie Children's Hospital of Chicago
    Chicago, Illinois 60611, United States
    • Aaron Hamvas, MD · Contact
    • Aaron Hamvas, MD · Principal investigator
    Not yet recruiting
  • Indiana University
    Indianapolis, Indiana 46202, United States
    Completed
  • University of Iowa
    Iowa City, Iowa 52242, United States
    • Edward F. Bell, MD · Contact
    • Edward F. Bell, MD · Principal investigator
    Recruiting
  • Tufts Medical Center
    Boston, Massachusetts 02111, United States
    Completed
  • Harvard University
    Cambridge, Massachusetts 02138, United States
    Completed
  • Wayne State University
    Detroit, Michigan 48201, United States
    Completed
  • University of Mississippi Medical Center - Children's of Mississippi
    Jackson, Mississippi 39216, United States
    • Abhay Bhatt, MD · Contact
    • Abhay Bhatt, MD · Principal investigator
    Not yet recruiting
  • Children's Mercy Hospital
    Kansas City, Missouri 64108, United States
    Completed
  • University of New Mexico
    Albuquerque, New Mexico 87131, United States
    • Kristi L. Watterberg, MD · Contact
    • Kristi L. Watterberg, MD · Principal investigator
    Recruiting
  • University of Rochester
    Rochester, New York 14642, United States
    Active, not recruiting
  • RTI International
    Durham, North Carolina 27705, United States
    Active, not recruiting
  • Duke University
    Durham, North Carolina 27710, United States
    • C. Michael Cotten, MD, MHS · Contact
    • C. Michael Cotten, MD, MHS · Principal investigator
    Recruiting
  • Cincinnati Children's Medical Center
    Cincinnati, Ohio 45267, United States
    • Brenda Poindexter, MD MS · Contact
    • Brenda Poindexter, MD MS · Principal investigator
    Recruiting
  • Case Western Reserve University, Rainbow Babies and Children's Hospital
    Cleveland, Ohio 44106, United States
    • Michele C. Walsh, MD MS · Contact
    • Michele C. Walsh, MD MS · Principal investigator
    Recruiting
  • Research Institute at Nationwide Children's Hospital
    Columbus, Ohio 43205, United States
    Active, not recruiting
  • Univeristy of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
    • Eric Eichenwald, MD · Contact
    • Eric Eichenwald, MD · Principal investigator
    Recruiting
  • Brown University, Women & Infants Hospital of Rhode Island
    Providence, Rhode Island 02905, United States
    Active, not recruiting
  • University of Tennessee
    Memphis, Tennessee 38163, United States
    Completed
  • University of Texas Southwestern Medical Center at Dallas
    Dallas, Texas 75235, United States
    • Myra H Wyckoff, MD · Contact
    • Myra H Wyckoff, MD · Principal investigator
    Recruiting
  • University of Texas Health Science Center at Houston
    Houston, Texas 77030, United States
    • Jon E. Tyson, MD MPH · Contact
    • Jon E. Tyson, MD MPH · Principal investigator
    Recruiting
  • University of Utah
    Salt Lake City, Utah 84108, United States
    • Bradley Yoder, MD · Contact
    • Bradley Yoder, MD · Principal investigator
    Recruiting
  • University of Vermont
    Burlington, Vermont 05405, United States
    Completed
07

References and documents

Publications

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  • 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. doi: 10.1542/peds.2007-0423. Epub 2008 Apr 7. PubMed 18390958 ↗
  • 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. doi: 10.1542/peds.2004-2099. PubMed 16322160 ↗
  • 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. doi: 10.1542/peds.2004-2292. PubMed 16396864 ↗
  • 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. doi: 10.1016/j.jpeds.2007.04.013. Epub 2007 Jul 12. PubMed 17961693 ↗
  • 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. doi: 10.1542/peds.114.2.404. PubMed 15286223 ↗
  • 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. doi: 10.1542/peds.2007-3449. PubMed 18762491 ↗
  • Cotten CM, 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. doi: 10.1038/sj.jp.7211369. PubMed 16079906 ↗
  • Cotten CM, Taylor S, Stoll B, Goldberg RN, Hansen NI, Sanchez 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. doi: 10.1542/peds.2007-3423. PubMed 19117861 ↗
  • 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. doi: 10.1111/j.1469-8749.2009.03318.x. PubMed 19459909 ↗
  • 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. doi: 10.1038/sj.jp.7200245. PubMed 10685271 ↗
  • Dollberg S, Demarini S, Donovan EF, Hoath SB. Maturation of thermal capabilities in preterm infants. Am J Perinatol. 2000;17(1):47-51. doi: 10.1055/s-2000-7293. PubMed 10928604 ↗
  • 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. doi: 10.1016/s0002-9378(98)70075-4. PubMed 9757982 ↗
  • 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. doi: 10.1038/sj.jp.7211256. PubMed 15861198 ↗
  • 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. doi: 10.1542/peds.2005-0249. PubMed 16322158 ↗
  • Ehrenkranz RA, Wright LL. NICHD neonatal research network: contributions and future challenges. Semin Perinatol. 2003 Aug;27(4):264-80. doi: 10.1016/s0146-0005(03)00041-7. PubMed 14510317 ↗
  • 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. doi: 10.1016/s0146-0005(03)00055-7. PubMed 14510318 ↗
  • 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. doi: 10.1016/j.ajog.2006.09.014. PubMed 17306659 ↗
  • 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. doi: 10.1016/0002-9378(95)90628-2. PubMed 7503180 ↗
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  • 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. doi: 10.1542/peds.2008-2742. PubMed 19564290 ↗
  • 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. doi: 10.1542/peds.2005-1543. Epub 2006 Jan 3. PubMed 16390920 ↗
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  • 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. doi: 10.1542/peds.2006-1465. PubMed 17606555 ↗
  • 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. doi: 10.1001/archpedi.162.8.748. PubMed 18678807 ↗
  • 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. doi: 10.1542/peds.2009-0810. Epub 2009 Dec 14. PubMed 20008430 ↗
  • 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. doi: 10.1542/peds.2004-0569. PubMed 15741374 ↗
  • 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. doi: 10.1542/peds.2004-2215. PubMed 15930228 ↗
  • Hintz SR, Kendrick DE, Vohr BR, Kenneth Poole W, Higgins RD; Nichd Neonatal Research Network. Gender differences in neurodevelopmental outcomes among extremely preterm, extremely-low-birthweight infants. Acta Paediatr. 2006 Oct;95(10):1239-48. doi: 10.1080/08035250600599727. PubMed 16982497 ↗
  • 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. doi: 10.1136/adc.2003.046268. PubMed 15724036 ↗
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  • 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. doi: 10.1542/peds.2004-0667. PubMed 15741371 ↗
  • 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. doi: 10.1542/peds.2006-0943. Epub 2007 Feb 12. PubMed 17296783 ↗
  • 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. doi: 10.1542/peds.107.1.e1. PubMed 11134465 ↗
  • 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. doi: 10.1097/00004703-200506000-00008. PubMed 15956871 ↗
  • 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. doi: 10.1542/peds.2007-2781. PubMed 19171637 ↗
  • 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. doi: 10.1542/peds.2007-0381. PubMed 18166553 ↗
  • 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. PubMed 2002969 ↗
  • 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. doi: 10.1038/sj.jp.7211361. PubMed 16107873 ↗
  • 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. doi: 10.1542/peds.112.4.773. PubMed 14523165 ↗
  • 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. doi: 10.1001/archpedi.1996.02170300045009. PubMed 8620230 ↗
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  • 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. doi: 10.1016/j.ajog.2004.05.032. PubMed 15507925 ↗
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  • 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. doi: 10.1016/s0146-0005(03)00056-9. PubMed 14510319 ↗
  • 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. doi: 10.1002/imhj.20196. PubMed 19779585 ↗
  • Stevenson DK, Verter J, Fanaroff AA, Oh W, Ehrenkranz RA, Shankaran S, Donovan EF, Wright LL, Lemons JA, Tyson JE, Korones SB, Bauer CR, Stoll BJ, Papile LA. Sex differences in outcomes of very low birthweight infants: the newborn male disadvantage. Arch Dis Child Fetal Neonatal Ed. 2000 Nov;83(3):F182-5. doi: 10.1136/fn.83.3.f182. PubMed 11040165 ↗
  • 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. doi: 10.1016/s0002-9378(98)70037-7. PubMed 9855609 ↗
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  • Stoll BJ, Hansen NI, Bell EF, Walsh MC, Carlo WA, Shankaran S, Laptook AR, Sanchez PJ, Van Meurs KP, Wyckoff M, Das A, Hale EC, Ball MB, Newman NS, Schibler K, Poindexter BB, Kennedy KA, Cotten CM, Watterberg KL, D'Angio CT, DeMauro SB, Truog WE, Devaskar U, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Trends in Care Practices, Morbidity, and Mortality of Extremely Preterm Neonates, 1993-2012. JAMA. 2015 Sep 8;314(10):1039-51. doi: 10.1001/jama.2015.10244. PubMed 26348753 ↗
  • LeVan JM, Brion LP, Wrage LA, Gantz MG, Wyckoff MH, Sanchez PJ, Heyne R, Jaleel M, Finer NN, Carlo WA, Das A, Stoll BJ, Higgins RD; Eunice Kennedy Shriver NICHD Neonatal Research Network. Change in practice after the Surfactant, Positive Pressure and Oxygenation Randomised Trial. Arch Dis Child Fetal Neonatal Ed. 2014 Sep;99(5):F386-90. doi: 10.1136/archdischild-2014-306057. Epub 2014 May 29. PubMed 24876196 ↗
08

Registry details

Key details

Study ID
NCT00063063
Lead sponsor
NICHD Neonatal Research Network
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
Sponsor
First posted
Jun 20, 2003
Start date
Apr 1, 1987
Primary completion
Mar 31, 2030 (estimated)
Completion
Mar 31, 2030 (estimated)
Last update
Mar 16, 2026

Study contacts

Ravi M Patal, MD
Contact
rmpatel@emory.edu
404-727-5905
Abhik Das, PhD
Contact
adas@rti.org
301-230-4640
Abbot R Laptook, MD
principal investigator · Brown University, Women & Infants Hospital of Rhode Island
Anna Maria Hibbs, MD, MSCE, FAAP
principal investigator · Case Western Reserve University, Rainbow Babies and Children's Hospital
C. Michael Cotten, MD
principal investigator · Duke University
Ravi M Patel, MD, MSc
study chair · Emory University
Abhik Das, PhD
principal investigator · RTI International
Krisa P Van Meurs, MD
principal investigator · Stanford University
Stephanie Merhar, MD MS
principal investigator · Children's Hospital Medical Center, Cincinnati
Waldemar A Carlo, MD
principal investigator · University of Alabama at Birmingham
Tarah Colaizy, MD, MPH
principal investigator · University of Iowa
Kristi L Watterberg, MD
principal investigator · University of New Mexico
Myra Wyckoff, MD
principal investigator · University of Texas, Southwestern Medical Center at Dallas
Jon E Tyson, MD MPH
principal investigator · The University of Texas Health Science Center, Houston
Sara DeMauro, MD, MSCE
principal investigator · University of Pennsylvania
Carl D'Angio, MD
principal investigator · University of Rochester
Pablo Sanchez, MD
principal investigator · Research Institute at Nationwide Children's Hospital
Robin Ohls, MD
principal investigator · University of Utah

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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