18 Month Follow-up Visit of High Risk Infants (FU)

This study is currently recruiting participants.

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

Sponsor:

Collaborator:

National Center for Research Resources (NCRR)

Information provided by (Responsible Party):

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

ClinicalTrials.gov Identifier:

NCT00009633

First received: February 1, 2001

Last updated: February 13, 2013

Last verified: January 2013

History of Changes

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 4

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

Resource links provided by NLM:

MedlinePlus related topics: Birth Weight Premature Babies

U.S. FDA Resources

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

Primary Outcome Measures:

To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner [ Time Frame: Longitudinal database currently funded through 3/31/2011 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To examine the relationship between baseline characteristics and outcome [ Time Frame: Longitudinal database currently funded through 3/31/2011 ] [ Designated as safety issue: No ]
To provide data for hypothesis formulation and sample size calculation for Network multi-center studies [ Time Frame: Longitudinal database currently funded through 3/31/2011 ] [ Designated as safety issue: No ]

Estimated Enrollment:	68000
Study Start Date:	January 1993
Estimated Study Completion Date:	March 2016
Estimated Primary Completion Date:	March 2016 (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 22 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
Principal Investigator: Myriam Peralta-Carcelen, MD MPH
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
Principal Investigator: Susan R. Hintz, 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
Principal Investigator: Ira Adams-Chapman, 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
Principal Investigator: Anna M. Dusick, MD FAAP
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
Principal Investigator: Michael J. Acarregui, 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
Principal Investigator: Elisabeth C. McGowan, 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
Principal Investigator: Athina Pappas, 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
Principal Investigator: Janell Fuller, MD
United States, New York
University of Rochester	Completed
Rochester, New York, United States, 14642
United States, North Carolina
Wake Forest University	Completed
Charlotte, North Carolina, United States, 27157
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
Principal Investigator: Ricki F. Goldstein, MD
RTI International	Active, not recruiting
Durham, North Carolina, United States, 27705
United States, Ohio
Cincinnati Children's Medical Center	Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Kurt Schibler, MD 513-636-3972 kurt.schibler@cchmc.org
Contact: Cathy Grisby, BSN CCRC (513) 558-4953 grisbyca@email.uc.edu
Principal Investigator: Kurt Schibler, MD
Principal Investigator: Jean J. Steichen, MD
Case Western Reserve University, Rainbow Babies and Children's Hospital	Recruiting
Cleveland, Ohio, United States, 44106
Contact: Michele C. Walsh, MD MS 216-844-3759 mcw3@cwru.edu
Contact: Nancy S. Newman, BA RN (216) 368-3084 nxs5@cwru.edu
Principal Investigator: Michele C. Walsh, MD MS
Principal Investigator: Deanne E. Wilson-Costello, 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
Principal Investigator: Betty R. Vohr, MD
United States, Tennessee
University of Tennessee	Completed
Memphis, Tennessee, United States, 38163
United States, Texas
University of Texas Southwestern Medical Center at Dallas	Recruiting
Dallas, Texas, United States, 75235
Contact: Pablo J. Sanchez, MD 214-648-3753 Pablo.Sanchez@UTSouthwestern.edu
Contact: Diana M. Vasil, RNC-NIC (214) 648-3789 Diana.Vasil@utsouthwestern.edu
Principal Investigator: Pablo J. Sanchez, MD
Principal Investigator: Roy J. Heyne, 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
Principal Investigator: Patricia W. Evans, 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
Principal Investigator: Anna Bodnar, MD

Sponsors and Collaborators

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

National Center for Research Resources (NCRR)

Investigators

Principal Investigator:	Abbot R. Laptook, MD	Brown University, Women & Infants Hospital of Rhode Island
Principal Investigator:	Michele C. Walsh, MD MS	Case Western Reserve University, Rainbow Babies and Children's Hospital
Principal Investigator:	Ronald N. Goldberg, MD	Duke University
Principal Investigator:	Barbara J. Stoll, MD	Emory University
Principal Investigator:	Brenda B. Poindexter, MD MS	Indiana University
Principal Investigator:	Abhik Das, PhD	RTI International
Principal Investigator:	Krisa P. Van Meurs, MD	Stanford University
Principal Investigator:	Ivan D. Frantz III, MD	Tufts Medical Center
Principal Investigator:	Kurt Schibler, MD	Cincinnati Children's Medical Center
Principal Investigator:	Waldemar A. Carlo, MD	University of Alabama at Birmingham
Principal Investigator:	Edward F. Bell, MD	University of Iowa
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:

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

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

Publications:

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

Ambalavanan N, 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.

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.

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.

Bhandari V, Finer NN, Ehrenkranz RA, Saha S, Das A, Walsh MC, Engle WA, VanMeurs KP; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Synchronized nasal intermittent positive-pressure ventilation and neonatal outcomes. Pediatrics. 2009 Aug;124(2):517-26. Epub 2009 Jul 27.

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.

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.

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.

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.

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.

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.

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.

Higgins RD, Shankaran S. Hypothermia for hypoxic ischemic encephalopathy in infants > or =36 weeks. Early Hum Dev. 2009 Oct;85(10 Suppl):S49-52. Epub 2009 Sep 17.

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

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

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

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

Laptook 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.

[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.

Oh W, Stevenson DK, Tyson JE, Morris BH, Ahlfors CE, Bender GJ, Wong RJ, Perritt R, Vohr BR, Van Meurs KP, Vreman HJ, Das A, Phelps DL, O'Shea TM, Higgins RD; On Behalf of the NICHD Neonatal Research Network Bethesda MD. Influence of clinical status on the association between plasma total and unbound bilirubin and death or adverse neurodevelopmental outcomes in extremely low birth weight infants. Acta Paediatr. 2010 Jan 25; [Epub ahead of print]

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.

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.

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.

Sood BG, Madan A, Saha S, Schendel D, Thorsen P, Skogstrand K, Hougaard D, Shankaran S, Carlo W; NICHD neonatal research network. Perinatal systemic inflammatory response syndrome and retinopathy of prematurity. Pediatr Res. 2010 Apr;67(4):394-400.

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.

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.

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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.

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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:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00009633 History of Changes
Other Study ID Numbers:	NICHD-NRN-0007, U01HD019897, U01HD021466, U10HD021364, U10HD021373, U10HD021385, U10HD021397, U10HD021415, U01HD021438, U10HD027851, U10HD027853, U10HD027856, U10HD027871, U10HD027880, U10HD027881, U10HD027904, U10HD034167, U10HD034216, U10HD036790, U10HD040461, U10HD040492, U10HD040498, U10HD040521, U10HD040689, U10HD042638, U10HD053089, U10HD053109, U10HD053119, U10HD053124, UL1RR024139, UL1RR025744, M01RR000030, M01RR000032, M01RR000039, M01RR000044, M01RR000054, M01RR000059, M01RR000064, M01RR000070, M01RR000080, M01RR000633, M01RR000750, M01RR000997, M01RR008084, M01RR001032, M01RR002172, M01RR002635, M01RR007122, M01RR016587
Study First Received:	February 1, 2001
Last Updated:	February 13, 2013
Health Authority:	United States: Federal Government United States: Institutional Review Board

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

NICHD Neonatal Research Network
Extremely Low Birth Weight (ELBW)
Prematurity
Neurodevelopmental Outcome
Follow up studies

Additional relevant MeSH terms:

Birth Weight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013

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