Generic Database of Very Low Birth Weight Infants

Infant, Premature Clinical Trial

— GDB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00063063
• Other study ID #: NICHD-NRN-0001
• Secondary ID: U01HD019897U01HD
• Status: Recruiting
• Start date: January 1987
• Est. completion date: March 31, 2030

Study information

• Verified date: March 2023
• Source: NICHD Neonatal Research Network
• Contact: Ravi M Patal, MD
• Phone: 404-727-5905
• Email: rmpatel[@]emory.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80000
• Est. completion date: March 31, 2030
• Est. primary completion date: March 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 14 Days

Eligibility

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:

• 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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico
United States	Emory University	Atlanta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Tufts Medical Center	Boston	Massachusetts
United States	University of Vermont	Burlington	Vermont
United States	Harvard University	Cambridge	Massachusetts
United States	Northwestern Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Cincinnati Children's Medical Center	Cincinnati	Ohio
United States	Case Western Reserve University, Rainbow Babies and Children's Hospital	Cleveland	Ohio
United States	Research Institute at Nationwide Children's Hospital	Columbus	Ohio
United States	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas
United States	Wayne State University	Detroit	Michigan
United States	Duke University	Durham	North Carolina
United States	RTI International	Durham	North Carolina
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	University of Mississippi Medical Center - Children's of Mississippi	Jackson	Mississippi
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	University of California - Los Angeles	Los Angeles	California
United States	University of Tennessee	Memphis	Tennessee
United States	University of Miami	Miami	Florida
United States	Yale University	New Haven	Connecticut
United States	Stanford University	Palo Alto	California
United States	Univeristy of Pennsylvania	Philadelphia	Pennsylvania
United States	Brown University, Women & Infants Hospital of Rhode Island	Providence	Rhode Island
United States	University of Rochester	Rochester	New York
United States	University of Utah	Salt Lake City	Utah
United States	Sharp Mary Birch Hospital for Women & Newborns	San Diego	California
United States	University of California at San Diego	San Diego	California
United States	George Washington University	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
NICHD Neonatal Research Network	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

References & Publications (82)

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 — View Citation

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 — View Citation

Ambalavanan N, Carlo WA, Tyson JE, Langer JC, Walsh MC, Parikh NA, Das A, Van Meurs KP, Shankaran S, Stoll BJ, Higgins RD; Generic Database; Subcommittees of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Rese — View Citation

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 infant — View Citation

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 ultrasoun — View Citation

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. — View Citation

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 mon — View Citation

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 — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 H — View Citation

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. — View Citation

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 bronchopulmo — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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 19 — View Citation

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. doi: 10.1016/S0029-7844(97)00404-3. — View Citation

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. — View Citation

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 b — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. 201 — View Citation

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. Pe — View Citation

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: 10.108 — View Citation

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 se — View Citation

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' gestati — View Citation

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 D — View Citation

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. doi: 10.1097/00003246-199301000-00008. — View Citation

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 Developmen — View Citation

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 — View Citation

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 — View Citation

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. — View Citation

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 h — View Citation

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. — View Citation

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: 10.15 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 neurodeve — View Citation

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. 199 — View Citation

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) — View Citation

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 — View Citation

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 Oc — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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 Ne — View Citation

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 Instit — View Citation

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 Institu — View Citation

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. doi: 10.1016/j.jpeds.2004.02.045. — View Citation

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 — View Citation

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: th — View Citation

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 wit — View Citation

Stoll BJ, Hansen N. Infections in VLBW infants: studies from the NICHD Neonatal Research Network. Semin Perinatol. 2003 Aug;27(4):293-301. doi: 10.1016/s0146-0005(03)00046-6. — View Citation

Stoll BJ, Hansen NI, Adams-Chapman I, Fanaroff AA, Hintz SR, Vohr B, Higgins RD; National Institute of Child Health and Human Development Neonatal Research Network. Neurodevelopmental and growth impairment among extremely low-birth-weight infants with neo — View Citation

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 — View Citation

Strand M, Jobe AH. The multiple negative randomized controlled trials in perinatology--why? Semin Perinatol. 2003 Aug;27(4):343-50. doi: 10.1016/s0146-0005(03)00042-9. — View Citation

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. doi: — View Citation

Tyson JE, Stoll BJ. Evidence-based ethics and the care and outcome of extremely premature infants. Clin Perinatol. 2003 Jun;30(2):363-87. doi: 10.1016/s0095-5108(03)00028-9. — View Citation

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. — View Citation

Uauy RD, Fanaroff AA, Korones SB, Phillips EA, Phillips JB, Wright LL. Necrotizing enterocolitis in very low birth weight infants: biodemographic and clinical correlates. National Institute of Child Health and Human Development Neonatal Research Network. — View Citation

Vohr BR, Msall ME, Wilson D, Wright LL, McDonald S, Poole WK. Spectrum of gross motor function in extremely low birth weight children with cerebral palsy at 18 months of age. Pediatrics. 2005 Jul;116(1):123-9. doi: 10.1542/peds.2004-1810. — View Citation

Vohr BR, O'Shea M, Wright LL. Longitudinal multicenter follow-up of high-risk infants: why, who, when, and what to assess. Semin Perinatol. 2003 Aug;27(4):333-42. doi: 10.1016/s0146-0005(03)00045-4. — View Citation

Vohr BR, Tyson JE, Wright LL, Perritt RL, Li L, Poole WK; NICHD Neonatal Research Network. Maternal age, multiple birth, and extremely low birth weight infants. J Pediatr. 2009 Apr;154(4):498-503.e2. doi: 10.1016/j.jpeds.2008.10.044. Epub 2008 Dec 25. — View Citation

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 — View Citation

Vohr BR, Wright LL, Dusick AM, Perritt R, Poole WK, Tyson JE, Steichen JJ, Bauer CR, Wilson-Costello DE, Mayes LC; Neonatal Research Network. Center differences and outcomes of extremely low birth weight infants. Pediatrics. 2004 Apr;113(4):781-9. doi: 10 — View Citation

Vohr BR, Wright LL, Poole WK, McDonald SA. Neurodevelopmental outcomes of extremely low birth weight infants <32 weeks' gestation between 1993 and 1998. Pediatrics. 2005 Sep;116(3):635-43. doi: 10.1542/peds.2004-2247. — View Citation

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 Pe — View Citation

Wadhawan R, Oh W, Perritt RL, McDonald SA, Das A, Poole WK, Vohr BR, Higgins RD. Twin gestation and neurodevelopmental outcome in extremely low birth weight infants. Pediatrics. 2009 Feb;123(2):e220-7. doi: 10.1542/peds.2008-1126. Epub 2009 Jan 12. — View Citation

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 O — View Citation

Walden RV, Taylor SC, Hansen NI, Poole WK, Stoll BJ, Abuelo D, Vohr BR; National Institute of Child Health and Human Development Neonatal Research Network. Major congenital anomalies place extremely low birth weight infants at higher risk for poor growth — View Citation

Walsh MC, Morris BH, Wrage LA, Vohr BR, Poole WK, Tyson JE, Wright LL, Ehrenkranz RA, Stoll BJ, Fanaroff AA; National Institutes of Child Health and Human Development Neonatal Research Network. Extremely low birthweight neonates with protracted ventilatio — View Citation

Walsh MC, Yao Q, Horbar JD, Carpenter JH, Lee SK, Ohlsson A. Changes in the use of postnatal steroids for bronchopulmonary dysplasia in 3 large neonatal networks. Pediatrics. 2006 Nov;118(5):e1328-35. doi: 10.1542/peds.2006-0359. — View Citation

Wright LL, Horbar JD, Gunkel H, Verter J, Younes N, Andrews EB, Long W. Evidence from multicenter networks on the current use and effectiveness of antenatal corticosteroids in low birth weight infants. Am J Obstet Gynecol. 1995 Jul;173(1):263-9. doi: 10.1 — View Citation

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. doi: 10.1016/s0146-0005(05)80031-x. No abstract available. — View Citation

Wright LL, Verter J, Younes N, Stevenson D, Fanaroff AA, Shankaran S, Ehrenkranz RA, Donovan EF. Antenatal corticosteroid administration and neonatal outcome in very low birth weight infants: the NICHD Neonatal Research Network. Am J Obstet Gynecol. 1995 — View Citation

Wright LL. How to develop and manage a successful research network. Semin Pediatr Surg. 2002 Aug;11(3):175-80; discussion 180. doi: 10.1053/spsu.2002.33740. No abstract available. — View Citation

Wright LL; Papile LA. U.S. neonatal databases: methods and uses. Semin Neonatal 1997;2:159-69. (ancillary publication).

* Note: There are 82 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner		Longitudinal database currently funded through 3/31/2021
Secondary	To examine the relationship between baseline characteristics and outcome		Longitudinal database currently funded through 3/31/2021
Secondary	To monitor trends in incidence of various disease entities		Longitudinal database currently funded through 3/31/2021
Secondary	To monitor changes in VLBW and early gestational age survival		Longitudinal database currently funded through 3/31/2021
Secondary	To provide data for hypothesis formulation and sample size calculation for Network multi-center studies		Longitudinal database currently funded through 3/31/2021

External Links

•   NICHD Neonatal Research Network
•   NICHD Pregnancy & Perinatology Branch