Follow-up Visit of High Risk Infants

NCT ID: NCT00009633

Last Updated: 2025-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

68000 participants

Study Classification

OBSERVATIONAL

Study Start Date

1993-04-01

Study Completion Date

2030-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 22-26 months corrected age (Infants born prior to July 1, 2012 were seen 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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 22-26 months corrected age (Infants born prior to July 1, 2012 were seen at 18-22 month 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
* Assessing the relationship between growth and neurodevelopmental outcome
* Assessing the relationship between the socioeconomic status and developmental outcome
* 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); Child Behavior Checklist.

A sub-study will assess a reference group comprised of a limited number of healthy term infants born in Network centers to meet the following three aims: 1) to avoid potential ascertainment biases due to examiner expectations when only extremely preterm or other high-risk infants are assessed 2) in the absence of well-developed norms for the Bayley Scales, to define thresholds for impairment based on data for a representative sample of healthy children born at term in our centers and concurrently assessed by the same examiners as for our high-risk infants; and 3) to help identify and address when "drift" occurs over time in conducting and scoring Bayley assessments.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Registry Cohort

Registry Cohort

No Intervention

Intervention Type OTHER

No Intervention

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No Intervention

No Intervention

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Infants inborn at NRN centers
* \<27 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 27 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.
Minimum Eligible Age

18 Months

Maximum Eligible Age

26 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Center for Research Resources (NCRR)

NIH

Sponsor Role collaborator

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

NIH

Sponsor Role collaborator

NICHD Neonatal Research Network

NETWORK

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Abbot R. Laptook, MD

Role: PRINCIPAL_INVESTIGATOR

Brown University, Women & Infants Hospital of Rhode Island

Michele C. Walsh, MD MS

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University, Rainbow Babies and Children's Hospital

C. Michael Cotten, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Duke University

David P. Carlton, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Greg M. Sokol, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Abhik Das, PhD

Role: PRINCIPAL_INVESTIGATOR

RTI International

Krisa P. Van Meurs, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Brenda B. Poindexter, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Waldemar A. Carlo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Edward F. Bell, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Kristi L. Watterberg, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Myra H. Wyckoff, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas, Southwestern Medical Center at Dallas

Jon E Tyson, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Bradley A. Yoder, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Seetha Shankaran, MD

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

William E. Truog, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Mercy Hospital Kansas City

Pablo J. Sanchez, MD

Role: PRINCIPAL_INVESTIGATOR

Research Institute at Nationwide Children's Hospital

Uday Devaskar, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Carl T D'Angio, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Eric C Eichenwald, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status RECRUITING

University of California - Los Angeles

Los Angeles, California, United States

Site Status RECRUITING

Stanford University

Palo Alto, California, United States

Site Status RECRUITING

University of California at San Diego

San Diego, California, United States

Site Status COMPLETED

Sharp Mary Birch Hospital for Women & Newborns

San Diego, California, United States

Site Status NOT_YET_RECRUITING

Yale University

New Haven, Connecticut, United States

Site Status COMPLETED

George Washington University

Washington D.C., District of Columbia, United States

Site Status COMPLETED

University of Miami

Miami, Florida, United States

Site Status COMPLETED

Emory University

Atlanta, Georgia, United States

Site Status RECRUITING

Northwestern Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Site Status NOT_YET_RECRUITING

Indiana University

Indianapolis, Indiana, United States

Site Status RECRUITING

University of Iowa

Iowa City, Iowa, United States

Site Status RECRUITING

Tufts Medical Center

Boston, Massachusetts, United States

Site Status COMPLETED

Harvard University

Cambridge, Massachusetts, United States

Site Status COMPLETED

Wayne State University

Detroit, Michigan, United States

Site Status RECRUITING

University of Mississippi Medical Center - Children's of Mississippi

Jackson, Mississippi, United States

Site Status NOT_YET_RECRUITING

Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status RECRUITING

University of New Mexico

Albuquerque, New Mexico, United States

Site Status RECRUITING

University of Rochester

Rochester, New York, United States

Site Status ACTIVE_NOT_RECRUITING

Wake Forest University

Charlotte, North Carolina, United States

Site Status COMPLETED

RTI International

Durham, North Carolina, United States

Site Status ACTIVE_NOT_RECRUITING

Duke University

Durham, North Carolina, United States

Site Status RECRUITING

Cincinnati Children's Medical Center

Cincinnati, Ohio, United States

Site Status RECRUITING

Case Western Reserve University, Rainbow Babies and Children's Hospital

Cleveland, Ohio, United States

Site Status RECRUITING

Research Institute at Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Brown University, Women & Infants Hospital of Rhode Island

Providence, Rhode Island, United States

Site Status ACTIVE_NOT_RECRUITING

University of Tennessee

Memphis, Tennessee, United States

Site Status COMPLETED

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

Site Status RECRUITING

University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status RECRUITING

University of Utah

Salt Lake City, Utah, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Susan R Hintz, MD, MS Epi

Role: CONTACT

Abhik Das, PhD

Role: CONTACT

301 230 4640

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Waldemar A. Carlo, MD

Role: primary

Uday Devaskar, MD

Role: primary

Krisa P. Van Meurs, MD

Role: primary

Anup Katheria, MD

Role: primary

David P. Carlton, MD

Role: primary

Aaron Hamvas, MD

Role: primary

Greg Sokol, MD

Role: primary

Edward F. Bell, MD

Role: primary

Seetha Shankaran, MD

Role: primary

Abhay Bhatt, MD

Role: primary

William Truog, MD

Role: primary

Kristi L. Watterberg, MD

Role: primary

C. Michael Cotten, MD

Role: primary

Brenda Poindexter, MD,MS

Role: primary

Michele C. Walsh, MD MS

Role: primary

Eric Eichenwald, MD

Role: primary

Myra H Wyckoff, MD

Role: primary

Jon Tyson, MD MPH

Role: primary

Bradley Yoder, MD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Adams-Chapman I, Hansen NI, Stoll BJ, Higgins R; NICHD Research Network. Neurodevelopmental outcome of extremely low birth weight infants with posthemorrhagic hydrocephalus requiring shunt insertion. Pediatrics. 2008 May;121(5):e1167-77. doi: 10.1542/peds.2007-0423. Epub 2008 Apr 7.

Reference Type RESULT
PMID: 18390958 (View on PubMed)

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. doi: 10.1016/j.jpeds.2005.11.042.

Reference Type RESULT
PMID: 16647401 (View on PubMed)

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. doi: 10.1542/peds.2006-1591.

Reference Type RESULT
PMID: 17079582 (View on PubMed)

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. doi: 10.1542/peds.2004-1812. Epub 2005 Feb 15.

Reference Type RESULT
PMID: 15713907 (View on PubMed)

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. doi: 10.1542/peds.2008-0377.

Reference Type RESULT
PMID: 19117897 (View on PubMed)

Benjamin DK Jr, Stoll BJ, Fanaroff AA, McDonald SA, Oh W, Higgins RD, Duara S, Poole K, Laptook A, Goldberg R; National Institute of Child Health and Human Development Neonatal Research Network. Neonatal candidiasis among extremely low birth weight infants: risk factors, mortality rates, and neurodevelopmental outcomes at 18 to 22 months. Pediatrics. 2006 Jan;117(1):84-92. doi: 10.1542/peds.2004-2292.

Reference Type RESULT
PMID: 16396864 (View on PubMed)

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. doi: 10.1542/peds.2008-1302. Epub 2009 Jul 27.

Reference Type RESULT
PMID: 19651577 (View on PubMed)

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. doi: 10.1542/peds.2005-1273. Epub 2006 Mar 20.

Reference Type RESULT
PMID: 16549503 (View on PubMed)

Broitman E, Ambalavanan N, Higgins RD, Vohr BR, Das A, Bhaskar B, Murray K, Hintz SR, Carlo WA; National Institute of Child Health and Human Development Neonatal Research Network. Clinical data predict neurodevelopmental outcome better than head ultrasound in extremely low birth weight infants. J Pediatr. 2007 Nov;151(5):500-5, 505.e1-2. doi: 10.1016/j.jpeds.2007.04.013. Epub 2007 Jul 12.

Reference Type RESULT
PMID: 17961693 (View on PubMed)

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.

Reference Type RESULT
PMID: 15286223 (View on PubMed)

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. doi: 10.1055/s-0028-1104743. Epub 2008 Dec 9.

Reference Type RESULT
PMID: 19067285 (View on PubMed)

Cole CR, Hansen NI, Higgins RD, Ziegler TR, Stoll BJ; Eunice Kennedy Shriver NICHD Neonatal Research Network. Very low birth weight preterm infants with surgical short bowel syndrome: incidence, morbidity and mortality, and growth outcomes at 18 to 22 months. Pediatrics. 2008 Sep;122(3):e573-82. doi: 10.1542/peds.2007-3449.

Reference Type RESULT
PMID: 18762491 (View on PubMed)

Da Costa D, Bann CM, Hansen NI, Shankaran S, Delaney-Black V; National Institute of Child Health and Human Development Neonatal Research Network. Validation of the Functional Status II questionnaire in the assessment of extremely-low-birthweight infants. Dev Med Child Neurol. 2009 Jul;51(7):536-44. doi: 10.1111/j.1469-8749.2009.03318.x.

Reference Type RESULT
PMID: 19459909 (View on PubMed)

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. doi: 10.1016/s0146-0005(03)00044-2.

Reference Type RESULT
PMID: 14510321 (View on PubMed)

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. doi: 10.1542/peds.2005-1368.

Reference Type RESULT
PMID: 16585322 (View on PubMed)

Ehrenkranz RA, Walsh MC, Vohr BR, Jobe AH, Wright LL, Fanaroff AA, Wrage LA, Poole K; National Institutes of Child Health and Human Development Neonatal Research Network. Validation of the National Institutes of Health consensus definition of bronchopulmonary dysplasia. Pediatrics. 2005 Dec;116(6):1353-60. doi: 10.1542/peds.2005-0249.

Reference Type RESULT
PMID: 16322158 (View on PubMed)

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.

Reference Type RESULT
PMID: 19564290 (View on PubMed)

Heller CD, O'Shea M, Yao Q, Langer J, Ehrenkranz RA, Phelps DL, Poole WK, Stoll B, Duara S, Oh W, Lemons J, Poindexter B; NICHD Neonatal Research Network. Human milk intake and retinopathy of prematurity in extremely low birth weight infants. Pediatrics. 2007 Jul;120(1):1-9. doi: 10.1542/peds.2006-1465.

Reference Type RESULT
PMID: 17606555 (View on PubMed)

Higgins RD, Shankaran S. Hypothermia for hypoxic ischemic encephalopathy in infants > or =36 weeks. Early Hum Dev. 2009 Oct;85(10 Suppl):S49-52. doi: 10.1016/j.earlhumdev.2009.08.015. Epub 2009 Sep 17.

Reference Type RESULT
PMID: 19762176 (View on PubMed)

Hintz SR, Kendrick DE, Vohr BR, Poole WK, Higgins RD; National Institute of Child Health and Human Development (NICHD) Neonatal Research Network. Community supports after surviving extremely low-birth-weight, extremely preterm birth: special outpatient services in early childhood. Arch Pediatr Adolesc Med. 2008 Aug;162(8):748-55. doi: 10.1001/archpedi.162.8.748.

Reference Type RESULT
PMID: 18678807 (View on PubMed)

Hintz SR, Kendrick DE, Stoll BJ, Vohr BR, Fanaroff AA, Donovan EF, Poole WK, Blakely ML, Wright L, Higgins R; NICHD Neonatal Research Network. Neurodevelopmental and growth outcomes of extremely low birth weight infants after necrotizing enterocolitis. Pediatrics. 2005 Mar;115(3):696-703. doi: 10.1542/peds.2004-0569.

Reference Type RESULT
PMID: 15741374 (View on PubMed)

Hintz SR, Kendrick DE, Vohr BR, Poole WK, Higgins RD; National Institute of Child Health and Human Development Neonatal Research Network. Changes in neurodevelopmental outcomes at 18 to 22 months' corrected age among infants of less than 25 weeks' gestational age born in 1993-1999. Pediatrics. 2005 Jun;115(6):1645-51. doi: 10.1542/peds.2004-2215.

Reference Type RESULT
PMID: 15930228 (View on PubMed)

Hintz SR, Kendrick DE, Vohr BR, Kenneth Poole W, Higgins RD; Nichd Neonatal Research Network. Gender differences in neurodevelopmental outcomes among extremely preterm, extremely-low-birthweight infants. Acta Paediatr. 2006 Oct;95(10):1239-48. doi: 10.1080/08035250600599727.

Reference Type RESULT
PMID: 16982497 (View on PubMed)

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. doi: 10.1016/j.jpeds.2007.03.017.

Reference Type RESULT
PMID: 17586184 (View on PubMed)

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. doi: 10.1016/j.jpeds.2006.11.065.

Reference Type RESULT
PMID: 17307536 (View on PubMed)

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. doi: 10.1542/peds.2006-0899. Epub 2007 Apr 2.

Reference Type RESULT
PMID: 17403821 (View on PubMed)

Laptook AR, O'Shea TM, Shankaran S, Bhaskar B; NICHD Neonatal Network. Adverse neurodevelopmental outcomes among extremely low birth weight infants with a normal head ultrasound: prevalence and antecedents. Pediatrics. 2005 Mar;115(3):673-80. doi: 10.1542/peds.2004-0667.

Reference Type RESULT
PMID: 15741371 (View on PubMed)

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. doi: 10.1542/peds.2007-1673.

Reference Type RESULT
PMID: 18762517 (View on PubMed)

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. doi: 10.1542/peds.2007-1103.

Reference Type RESULT
PMID: 18245420 (View on PubMed)

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.

Reference Type RESULT
PMID: 15956871 (View on PubMed)

Madan JC, Kendrick D, Hagadorn JI, Frantz ID 3rd; National Institute of Child Health and Human Development Neonatal Research Network. Patent ductus arteriosus therapy: impact on neonatal and 18-month outcome. Pediatrics. 2009 Feb;123(2):674-81. doi: 10.1542/peds.2007-2781.

Reference Type RESULT
PMID: 19171637 (View on PubMed)

Malcolm WF, Gantz M, Martin RJ, Goldstein RF, Goldberg RN, Cotten CM; National Institute of Child Health and Human Development Neonatal Research Network. Use of medications for gastroesophageal reflux at discharge among extremely low birth weight infants. Pediatrics. 2008 Jan;121(1):22-7. doi: 10.1542/peds.2007-0381.

Reference Type RESULT
PMID: 18166553 (View on PubMed)

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. doi: 10.1056/NEJMoa0803024.

Reference Type RESULT
PMID: 18971491 (View on PubMed)

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.

Reference Type RESULT
PMID: 16107873 (View on PubMed)

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. doi: 10.1067/mpd.2000.104826.

Reference Type RESULT
PMID: 10802492 (View on PubMed)

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. doi: 10.1016/j.jpeds.2008.03.041. Epub 2008 May 9.

Reference Type RESULT
PMID: 18534246 (View on PubMed)

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; 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 May;99(5):673-678. doi: 10.1111/j.1651-2227.2010.01688.x. Epub 2010 Jan 25.

Reference Type RESULT
PMID: 20105142 (View on PubMed)

Oh W, Tyson JE, Fanaroff AA, Vohr BR, Perritt R, Stoll BJ, Ehrenkranz RA, Carlo WA, Shankaran S, Poole K, Wright LL; National Institute of Child Health and Human Development Neonatal Research Network. Association between peak serum bilirubin and neurodevelopmental outcomes in extremely low birth weight infants. Pediatrics. 2003 Oct;112(4):773-9. doi: 10.1542/peds.112.4.773.

Reference Type RESULT
PMID: 14523165 (View on PubMed)

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. doi: 10.1542/peds.2003-1129-L.

Reference Type RESULT
PMID: 15520109 (View on PubMed)

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. doi: 10.1542/peds.2008-0135.

Reference Type RESULT
PMID: 19403482 (View on PubMed)

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. doi: 10.1016/j.jpeds.2005.10.038.

Reference Type RESULT
PMID: 16615955 (View on PubMed)

Schmidt B, Davis P, Moddemann D, Ohlsson A, Roberts RS, Saigal S, Solimano A, Vincer M, Wright LL; Trial of Indomethacin Prophylaxis in Preterms Investigators. Long-term effects of indomethacin prophylaxis in extremely-low-birth-weight infants. N Engl J Med. 2001 Jun 28;344(26):1966-72. doi: 10.1056/NEJM200106283442602.

Reference Type RESULT
PMID: 11430325 (View on PubMed)

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. doi: 10.1016/j.jpeds.2006.01.047.

Reference Type RESULT
PMID: 16769377 (View on PubMed)

Shankaran S. Neonatal encephalopathy: treatment with hypothermia. J Neurotrauma. 2009 Mar;26(3):437-43. doi: 10.1089/neu.2008.0678.

Reference Type RESULT
PMID: 19281415 (View on PubMed)

Shankaran S, Johnson Y, Langer JC, Vohr BR, Fanaroff AA, Wright LL, Poole WK. Outcome of extremely-low-birth-weight infants at highest risk: gestational age < or =24 weeks, birth weight < or =750 g, and 1-minute Apgar < or =3. Am J Obstet Gynecol. 2004 Oct;191(4):1084-91. doi: 10.1016/j.ajog.2004.05.032.

Reference Type RESULT
PMID: 15507925 (View on PubMed)

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. doi: 10.1056/NEJMcps050929.

Reference Type RESULT
PMID: 16221780 (View on PubMed)

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. doi: 10.1056/NEJM199708143370705.

Reference Type RESULT
PMID: 9250849 (View on PubMed)

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. doi: 10.1067/mob.2002.122445.

Reference Type RESULT
PMID: 12114906 (View on PubMed)

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. doi: 10.1542/peds.2008-0456.

Reference Type RESULT
PMID: 18829776 (View on PubMed)

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. doi: 10.1203/PDR.0b013e3181d01a36.

Reference Type RESULT
PMID: 20032809 (View on PubMed)

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.

Reference Type RESULT
PMID: 19779585 (View on PubMed)

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. doi: 10.1001/jama.292.19.2357.

Reference Type RESULT
PMID: 15547163 (View on PubMed)

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.

Reference Type RESULT
PMID: 8922450 (View on PubMed)

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: 10.1056/NEJMoa073059.

Reference Type RESULT
PMID: 18420500 (View on PubMed)

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. doi: 10.1056/NEJMoa043927.

Reference Type RESULT
PMID: 16000352 (View on PubMed)

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.

Reference Type RESULT
PMID: 15995042 (View on PubMed)

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.

Reference Type RESULT
PMID: 14510324 (View on PubMed)

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. doi: 10.1542/peds.2005-2382.

Reference Type RESULT
PMID: 16818526 (View on PubMed)

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. doi: 10.1542/peds.105.6.1216.

Reference Type RESULT
PMID: 10835060 (View on PubMed)

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.

Reference Type RESULT
PMID: 16143580 (View on PubMed)

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. doi: 10.1542/peds.2006-3227.

Reference Type RESULT
PMID: 17908750 (View on PubMed)

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.

Reference Type RESULT
PMID: 19111322 (View on PubMed)

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: 10.1542/peds.113.4.781.

Reference Type RESULT
PMID: 15060228 (View on PubMed)

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.

Reference Type RESULT
PMID: 19139085 (View on PubMed)

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. doi: 10.1067/s0002-9378(03)00360-0.

Reference Type RESULT
PMID: 14520225 (View on PubMed)

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. doi: 10.1542/peds.2007-0354. Epub 2007 Nov 5.

Reference Type RESULT
PMID: 17984212 (View on PubMed)

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. doi: 10.1016/j.jpeds.2005.01.047.

Reference Type RESULT
PMID: 15973322 (View on PubMed)

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. doi: 10.1542/peds.2008-1928. Epub 2009 Feb 9.

Reference Type RESULT
PMID: 19204058 (View on PubMed)

Duncan AF, Watterberg KL, Nolen TL, Vohr BR, Adams-Chapman I, Das A, Lowe J; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Effect of ethnicity and race on cognitive and language testing at age 18-22 months in extremely preterm infants. J Pediatr. 2012 Jun;160(6):966-71.e2. doi: 10.1016/j.jpeds.2011.12.009. Epub 2012 Jan 23.

Reference Type RESULT
PMID: 22269248 (View on PubMed)

Merhar SL, Tabangin ME, Meinzen-Derr J, Schibler KR. Grade and laterality of intraventricular haemorrhage to predict 18-22 month neurodevelopmental outcomes in extremely low birthweight infants. Acta Paediatr. 2012 Apr;101(4):414-8. doi: 10.1111/j.1651-2227.2011.02584.x. Epub 2012 Jan 16.

Reference Type RESULT
PMID: 22220735 (View on PubMed)

Payne AH, Hintz SR, Hibbs AM, Walsh MC, Vohr BR, Bann CM, Wilson-Costello DE; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Neurodevelopmental outcomes of extremely low-gestational-age neonates with low-grade periventricular-intraventricular hemorrhage. JAMA Pediatr. 2013 May;167(5):451-9. doi: 10.1001/jamapediatrics.2013.866.

Reference Type RESULT
PMID: 23460139 (View on PubMed)

Rysavy MA, Bell EF, Iams JD, Carlo WA, Li L, Mercer BM, Hintz SR, Stoll BJ, Vohr BR, Shankaran S, Walsh MC, Brumbaugh JE, Colaizy TT, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Discordance in Antenatal Corticosteroid Use and Resuscitation Following Extremely Preterm Birth. J Pediatr. 2019 May;208:156-162.e5. doi: 10.1016/j.jpeds.2018.12.063. Epub 2019 Feb 6.

Reference Type DERIVED
PMID: 30738658 (View on PubMed)

Boghossian NS, Do BT, Bell EF, Dagle JM, Brumbaugh JE, Stoll BJ, Vohr BR, Das A, Shankaran S, Sanchez PJ, Wyckoff MH, Bethany Ball M; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Efficacy of pharmacologic closure of patent ductus arteriosus in small-for-gestational-age extremely preterm infants. Early Hum Dev. 2017 Oct;113:10-17. doi: 10.1016/j.earlhumdev.2017.07.011. Epub 2017 Jul 8.

Reference Type DERIVED
PMID: 28697406 (View on PubMed)

Younge N, Goldstein RF, Bann CM, Hintz SR, Patel RM, Smith PB, Bell EF, Rysavy MA, Duncan AF, Vohr BR, Das A, Goldberg RN, Higgins RD, Cotten CM; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Survival and Neurodevelopmental Outcomes among Periviable Infants. N Engl J Med. 2017 Feb 16;376(7):617-628. doi: 10.1056/NEJMoa1605566.

Reference Type DERIVED
PMID: 28199816 (View on PubMed)

Boghossian NS, Hansen NI, Bell EF, Brumbaugh JE, Stoll BJ, Laptook AR, Shankaran S, Wyckoff MH, Colaizy TT, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Outcomes of Extremely Preterm Infants Born to Insulin-Dependent Diabetic Mothers. Pediatrics. 2016 Jun;137(6):e20153424. doi: 10.1542/peds.2015-3424. Epub 2016 May 13.

Reference Type DERIVED
PMID: 27244849 (View on PubMed)

Salas AA, Carlo WA, Ambalavanan N, Nolen TL, Stoll BJ, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Gestational age and birthweight for risk assessment of neurodevelopmental impairment or death in extremely preterm infants. Arch Dis Child Fetal Neonatal Ed. 2016 Nov;101(6):F494-F501. doi: 10.1136/archdischild-2015-309670. Epub 2016 Feb 19.

Reference Type DERIVED
PMID: 26895876 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://neonatal.rti.org/

NICHD Neonatal Research Network

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U24HD095254

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UG1HD068263

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UG1HD034216

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UG1HD021364

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UG1HD027853

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UG1HD027851

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UG1HD053109

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UG1HD112079

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UG1HD112093

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UG1HD027904

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UG1HD053089

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UG1HD068244

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UG1HD027880

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UG1HD087226

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UG1HD040689

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UG1HD040492

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UG1HD112097

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UG1HD112100

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UG1HD068278

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NICHD-NRN-0007

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

2 Year Follow up of COSGOD III
NCT06141733 COMPLETED
Developmental Outcomes
NCT02264808 COMPLETED
Non-invasive Ventilation in Preterm Infants
NCT05987800 ACTIVE_NOT_RECRUITING NA