Full Text View
Tabular View
No Study Results Posted
Related Studies
18 Month Follow-up Visit of High Risk Infants (FU)
This study is currently recruiting participants.
Verified by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), November 2009
First Received: February 1, 2001   Last Updated: November 6, 2009   History of Changes
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00009633
  Purpose

The NICHD Neonatal Research Network's Follow-Up study is a multi-center cohort in which surviving extremely low birth-weight infants born in participating network centers receive neurodevelopmental, neurosensory and functional assessments at 18-22 months corrected age. Data regarding pregnancy and neonatal outcome are collected prospectively. The goal is to identify potential maternal and neonatal risk factors that may affect infant neurodevelopment.


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

Study Type: Observational
Study Design: Cohort, Prospective
Official Title: 18 Month Follow-up Visit of High Risk Infants

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 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 1993
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Detailed Description:

The NICHD Neonatal Research Network's Follow-Up study is a multi-center cohort study in which surviving extremely low birth-weight infants undergo neurodevelopmental, neurosensory and functional assessments at 18-22 months corrected age. The goal of the study is to identify potential maternal and neonatal risk factors that may affect infant neurodevelopment, including:

  • Evaluating development of motor skills, cognitive skills, language and behavior
  • Determining mortality and the prevalence of specific medical conditions in ELBW infants
  • Assessing the relationship between growth and neurodevelopmental outcome
  • Assessing the relationship between the socioeconomic status and developmental outcome
  • Identifying significant family stress in this population and compliance with medical and developmental care
  • Assessing the use of special support services and early intervention programs by this population
  • Evaluating the need for follow-up at school age.

The scheduled evaluations collect: demographic information; socioeconomic status; medical history; medications; medical equipment required; growth data; a detailed neurologic examination; Bayley Scales of Infant Development (mental, motor, infant behavior); Family Resource Scale; Stein Functional Status II Measure and the Stein Impact on the Family Scale.

  Eligibility

Ages Eligible for Study:   18 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Infants born at 401-1000 grams birth weight and/or <29 weeks gestational age

Criteria
  • Infants inborn at NRN centers
  • 401-1,000 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 Follow-up studies. For infants that do not meet the inclusion criteria above, inclusion and exclusion criteria 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 FU Study.

Note: These inclusion criteria were changed as of 1/1/2008. Prior to this date, infants with birth weights between 401 and 1500 grams who were 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: NCT00009633

Contacts
Contact: Betty R. Vohr, MD (401) 274-1122 ext 1235 bvohr@wihri.org
Contact: Rosemary D. Higgins, MD 301-496-5575 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
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 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, 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 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            
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, 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 Completed
Rochester, New York, United States, 14642
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 Recruiting
Durham, North Carolina, United States, 27705
Contact: Abhik Das, PhD     301-230-4640     adas@rti.org    
Contact: Kristin Zaterka-Baxter, RN     (919) 485-7750     kzaterka@rti.org    
Principal Investigator: Abhik Das, PhD            
Wake Forest University Completed
Charlotte, North Carolina, United States, 27157
United States, Ohio
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            
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) 803-0950     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, 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: Nancy A. Miller, RN     (214) 648-3780     Nancy.Miller@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            
Principal Investigator: Jon E. Tyson, MD MPH            
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
Eunice Kennedy Shriver 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, 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: 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
Principal Investigator: 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

Additional Information:
Click here for more information on the NICHD Neonatal Research Network.  This link exits the ClinicalTrials.gov site

Publications:
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 ventilation: mortality and 18-month neurodevelopmental outcomes. J Pediatr. 2005 Jun;146(6):798-804.
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.
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.
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.
Ambalavanan N, Tyson JE, Kennedy KA, Hansen NI, Vohr BR, Wright LL, Carlo WA; National Institute of Child Health and Human Development Neonatal Research Network. Vitamin A supplementation for extremely low birth weight infants: outcome at 18 to 22 months. Pediatrics. 2005 Mar;115(3):e249-54. Epub 2005 Feb 15.
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 neonatal infection. JAMA. 2004 Nov 17;292(19):2357-65.
Ohls RK, Ehrenkranz RA, Das A, Dusick AM, Yolton K, Romano E, Delaney-Black V, Papile LA, Simon NP, Steichen JJ, Lee KG; National Institute of Child Health and Human Development Neonatal Research Network. Neurodevelopmental outcome and growth at 18 to 22 months' corrected age in extremely low birth weight infants treated with early erythropoietin and iron. Pediatrics. 2004 Nov;114(5):1287-91.
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.
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.
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.
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.
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. Review.
Dusick AM, Poindexter BB, Ehrenkranz RA, Lemons JA. Growth failure in the preterm infant: can we catch up? Semin Perinatol. 2003 Aug;27(4):302-10. Review.
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.
Bassler D, Stoll BJ, Schmidt B, Asztalos EV, Roberts RS, Robertson CM, Sauve RS; Trial of Indomethacin Prophylaxis in Preterms Investigators. Using a count of neonatal morbidities to predict poor outcome in extremely low birth weight infants: added role of neonatal infection. Pediatrics. 2009 Jan;123(1):313-8.
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.
Blakely ML, Tyson JE, Lally KP, McDonald S, Stoll BJ, Stevenson DK, Poole WK, Jobe AH, Wright LL, Higgins RD; NICHD Neonatal Research Network. Laparotomy versus peritoneal drainage for necrotizing enterocolitis or isolated intestinal perforation in extremely low birth weight infants: outcomes through 18 months adjusted age. Pediatrics. 2006 Apr;117(4):e680-7. Epub 2006 Mar 20.
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.
Chock VY, Van Meurs KP, Hintz SR, Ehrenkranz RA, Lemons JA, Kendrick DE, Stevenson DK; NICHD Neonatal Research Network. Inhaled nitric oxide for preterm premature rupture of membranes, oligohydramnios, and pulmonary hypoplasia. Am J Perinatol. 2009 Apr;26(4):317-22. Epub 2008 Dec 9.
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.
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.
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.
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, 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, Van Meurs KP, Perritt R, Poole WK, Das A, Stevenson DK, Ehrenkranz RA, Lemons JA, Vohr BR, Heyne R, Childers DO, Peralta-Carcelen M, Dusick A, Johnson YR, Morris B, Dillard R, Vaucher Y, Steichen J, Adams-Chapman I, Konduri G, Myers GJ, de Ungria M, Tyson JE, Higgins RD; NICHD Neonatal Research Network. Neurodevelopmental outcomes of premature infants with severe respiratory failure enrolled in a randomized controlled trial of inhaled nitric oxide. J Pediatr. 2007 Jul;151(1):16-22, 22.e1-3.
Konduri GG, Vohr B, Robertson C, Sokol GM, Solimano A, Singer J, Ehrenkranz RA, Singhal N, Wright LL, Van Meurs K, Stork E, Kirpalani H, Peliowski A, Johnson Y; Neonatal Inhaled Nitric Oxide Study Group. Early inhaled nitric oxide therapy for term and near-term newborn infants with hypoxic respiratory failure: neurodevelopmental follow-up. J Pediatr. 2007 Mar;150(3):235-40, 240.e1.
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 A, Tyson J, Shankaran S, McDonald S, Ehrenkranz R, Fanaroff A, Donovan E, Goldberg R, O'Shea TM, Higgins RD, Poole WK; National Institute of Child Health and Human Development Neonatal Research Network. Elevated temperature after hypoxic-ischemic encephalopathy: risk factor for adverse outcomes. Pediatrics. 2008 Sep;122(3):491-9.
Lee BH, Stoll BJ, McDonald SA, Higgins RD; National Institute of Child Health and Human Development Neonatal Research Network. Neurodevelopmental outcomes of extremely low birth weight infants exposed prenatally to dexamethasone versus betamethasone. Pediatrics. 2008 Feb;121(2):289-96.
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.
Morris BH, Oh W, Tyson JE, Stevenson DK, Phelps DL, O'Shea TM, McDavid GE, Perritt RL, Van Meurs KP, Vohr BR, Grisby C, Yao Q, Pedroza C, Das A, Poole WK, Carlo WA, Duara S, Laptook AR, Salhab WA, Shankaran S, Poindexter BB, Fanaroff AA, Walsh MC, Rasmussen MR, Stoll BJ, Cotten CM, Donovan EF, Ehrenkranz RA, Guillet R, Higgins RD; NICHD Neonatal Research Network. Aggressive vs. conservative phototherapy for infants with extremely low birth weight. N Engl J Med. 2008 Oct 30;359(18):1885-96.
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.
Ambalavanan N, Baibergenova A, Carlo WA, Saigal S, Schmidt B, Thorpe KE; Trial of Indomethacin Prophylaxis in Preterms (TIPP) Investigators. Early prediction of poor outcome in extremely low birth weight infants by classification tree analysis. J Pediatr. 2006 Apr;148(4):438-444.
Ambalavanan N, Carlo WA, Shankaran S, Bann CM, Emrich SL, Higgins RD, Tyson JE, O'Shea TM, Laptook AR, Ehrenkranz RA, Donovan EF, Walsh MC, Goldberg RN, Das A; National Institute of Child Health and Human Development Neonatal Research Network. Predicting outcomes of neonates diagnosed with hypoxemic-ischemic encephalopathy. Pediatrics. 2006 Nov;118(5):2084-93.
[No authors listed] Inhaled nitric oxide in term and near-term infants: neurodevelopmental follow-up of the neonatal inhaled nitric oxide study group (NINOS). J Pediatr. 2000 May;136(5):611-7.
Oh W, Perritt R, Shankaran S, Merritts M, Donovan EF, Ehrenkranz RA, O'Shea TM, Tyson JE, Laptook AR, Das A, Higgins RD. Association between urinary lactate to creatinine ratio and neurodevelopmental outcome in term infants with hypoxic-ischemic encephalopathy. J Pediatr. 2008 Sep;153(3):375-8. Epub 2008 May 9.
Peralta-Carcelen M, Moses M, Adams-Chapman I, Gantz M, Vohr BR; NICHD Neonatal Research Network; National Institutes of Health. Stability of neuromotor outcomes at 18 and 30 months of age after extremely low birth weight status. Pediatrics. 2009 May;123(5):e887-95.
Poindexter BB, Langer JC, Dusick AM, Ehrenkranz RA; National Institute of Child Health and Human Development Neonatal Research Network. Early provision of parenteral amino acids in extremely low birth weight infants: relation to growth and neurodevelopmental outcome. J Pediatr. 2006 Mar;148(3):300-305.
Schmidt B, Davis P, Moddemann D, Ohlsson A, Roberts RS, Saigal S, Solimano A, Vincer M, Wright LL. Long-term effects of indomethacin prophylaxis in extremely-low-birth-weight infants. N Engl J Med. 2001 Jun 28;344(26):1966-72.
Schmidt B, Roberts RS, Fanaroff A, Davis P, Kirpalani HM, Nwaesei C, Vincer M; TIPP Investigators. Indomethacin prophylaxis, patent ductus arteriosus, and the risk of bronchopulmonary dysplasia: further analyses from the Trial of Indomethacin Prophylaxis in Preterms (TIPP). J Pediatr. 2006 Jun;148(6):730-734.
Shankaran S. Neonatal encephalopathy: treatment with hypothermia. J Neurotrauma. 2009 Mar;26(3):437-43. Review.
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, Laptook AR, Ehrenkranz RA, Tyson JE, McDonald SA, Donovan EF, Fanaroff AA, Poole WK, Wright LL, Higgins RD, Finer NN, Carlo WA, Duara S, Oh W, Cotten CM, Stevenson DK, Stoll BJ, Lemons JA, Guillet R, Jobe AH; National Institute of Child Health and Human Development Neonatal Research Network. Whole-body hypothermia for neonates with hypoxic-ischemic encephalopathy. N Engl J Med. 2005 Oct 13;353(15):1574-84.
Shankaran S, Papile LA, Wright LL, Ehrenkranz RA, Mele L, Lemons JA, Korones SB, Stevenson DK, Donovan EF, Stoll BJ, Fanaroff AA, Oh W. The effect of antenatal phenobarbital therapy on neonatal intracranial hemorrhage in preterm infants. N Engl J Med. 1997 Aug 14;337(7):466-71.
Shankaran S, Papile LA, Wright LL, Ehrenkranz RA, Mele L, Lemons JA, Korones SB, Stevenson DK, Donovan EF, Stoll BJ, Fanaroff AA, Oh W, Verter J. Neurodevelopmental outcome of premature infants after antenatal phenobarbital exposure. Am J Obstet Gynecol. 2002 Jul;187(1):171-7.
Shankaran S, Pappas A, Laptook AR, McDonald SA, Ehrenkranz RA, Tyson JE, Walsh M, Goldberg RN, Higgins RD, Das A; NICHD Neonatal Research Network. Outcomes of safety and effectiveness in a multicenter randomized, controlled trial of whole-body hypothermia for neonatal hypoxic-ischemic encephalopathy. Pediatrics. 2008 Oct;122(4):e791-8.
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.
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.
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.
Van Meurs KP, Wright LL, Ehrenkranz RA, Lemons JA, Ball MB, Poole WK, Perritt R, Higgins RD, Oh W, Hudak ML, Laptook AR, Shankaran S, Finer NN, Carlo WA, Kennedy KA, Fridriksson JH, Steinhorn RH, Sokol GM, Konduri GG, Aschner JL, Stoll BJ, D'Angio CT, Stevenson DK; Preemie Inhaled Nitric Oxide Study. Inhaled nitric oxide for premature infants with severe respiratory failure. N Engl J Med. 2005 Jul 7;353(1):13-22.
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.
Vohr BR, Poindexter BB, Dusick AM, McKinley LT, Wright LL, Langer JC, Poole WK; NICHD Neonatal Research Network. Beneficial effects of breast milk in the neonatal intensive care unit on the developmental outcome of extremely low birth weight infants at 18 months of age. Pediatrics. 2006 Jul;118(1):e115-23.
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.
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.
Vohr BR, Poindexter BB, Dusick AM, McKinley LT, Higgins RD, Langer JC, Poole WK; National Institute of Child Health and Human Development National Research Network. Persistent beneficial effects of breast milk ingested in the neonatal intensive care unit on outcomes of extremely low birth weight infants at 30 months of age. Pediatrics. 2007 Oct;120(4):e953-9.
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. Epub 2008 Dec 25.
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. Epub 2009 Jan 12.
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 and developmental outcomes. Pediatrics. 2007 Dec;120(6):e1512-9. Epub 2007 Nov 5.
Wilson-Costello D, Walsh MC, Langer JC, Guillet R, Laptook AR, Stoll BJ, Shankaran S, Finer NN, Van Meurs KP, Engle WA, Das A; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Impact of postnatal corticosteroid use on neurodevelopment at 18 to 22 months' adjusted age: effects of dose, timing, and risk of bronchopulmonary dysplasia in extremely low birth weight infants. Pediatrics. 2009 Mar;123(3):e430-7. Epub 2009 Feb 9.

Responsible Party: Brown University, Women & Infants Hospital of Rhode Island ( Betty R. Vohr, Lead Principal Investigator )
Study ID Numbers: NICHD-NRN-0007, U01 HD19897 (GWU), U01 HD21466 (Vermont), U10 HD21364 (Case), U10 HD21373 (UT Houston), U10 HD21385 (Wayne), U10 HD21397 (Miami), U10 HD21415 (Tenn), U10 HD21438 (Alabama), U10 HD27851 (Emory), U10 HD27853 (Cincinnati), U10 HD27856 (Indiana), U10 HD27871 (Yale), U10 HD27880 (Stanford), U10 HD27881 (UNM), U10 HD27904 (Brown), U10 HD34167 (Harvard), U10 HD34216 (Alabama), U10 HD36790 (RTI), U10 HD40461 (UCSD), U10 HD40492 (Duke), U10 HD40498 (Wake), U10 HD40521 (Rochester), U10 HD40689 (UT Southwestern), U10 HD42638 (Tennessee), U10 HD53089 (UNM), U10 HD53109 (Iowa), U10 HD53119 (Tufts), U10 HD53124 (Utah), CTSA UL1 RR24139 (Yale), CTSA UL1 RR25744 (Stanford), CTSA UL1 RR25764 (Utah), CTSA UL1 RR25777 (Alabama), GCRC M01 RR30 (Duke), GCRC M01 RR32 (Alabama), GCRC M01 RR39 (Emory), GCRC M01 RR44 (Rochester), GCRC M01 RR54 (Tufts), GCRC M01 RR59 (Iowa), GCRC M01 RR64 (Utah), GCRC M01 RR70 (Stanford), GCRC M01 RR80 (Case), GCRC M01 RR633 (UT Southwest.), GCRC M01 RR750 (Indiana), GCRC M01 RR997 (UNM), GCRC M01 RR8084 (Cincinnati), GCRC M01 RR1032 (Harvard), GCRC M01 RR2172 (Harvard), GCRC M01 RR2588 (UT Houston), GCRC M01 RR2635 (Harvard), GCRC M01 RR6022 (Yale), GCRC M01 RR7122 (Wake), GCRC M01 RR16587 (Miami)
Study First Received: February 1, 2001
Last Updated: November 6, 2009
ClinicalTrials.gov Identifier: NCT00009633     History of Changes
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
Neurodevelopmental Outcome
Follow up studies

Additional relevant MeSH terms:
Body Weight
Birth Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 30, 2009



Contact Help Desk
Lister Hill National Center for Biomedical Communications,  U.S. National Library of Medicine,
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services