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Infant, NewbornFUNCT00009633

Follow-up Visit of High Risk Infants

An observational study of Infant, Newborn and Infant, Low Birth Weight, run by NICHD Neonatal Research Network at 31 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 26 months
How many people
68,000 participants
Where
31 sitesUnited States
Study dates
1 Apr 1993to 31 Mar 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 26 months
  • All sexes
  • No healthy volunteers
  • Child

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

  • 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.

Trial locations and contacts

31 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Susan R Hintz, MD, MS Epi contact

srhintz@stanford.edu

Abhik Das, PhD contact

301 230 4640

adas@rti.org

31 sites in 1 country

United States31 sites, 19 recruiting

  • University of New Mexico

    Albuquerque, New Mexico, 87131

    Kristi L. Watterberg, MD

    Kristi L. Watterberg, MD

    Recruiting

  • Emory University

    Atlanta, Georgia, 30303

    David P. Carlton, MD

    David P. Carlton, MD

    Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

    Waldemar A. Carlo, MD

    Waldemar A. Carlo, MD

    Recruiting

  • Tufts Medical Center

    Boston, Massachusetts, 02111

    Completed

  • Harvard University

    Cambridge, Massachusetts, 02138

    Completed

  • Wake Forest University

    Charlotte, North Carolina, 27157

    Completed

  • Northwestern Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611

    Aaron Hamvas, MD

    Aaron Hamvas, MD

    Not yet recruiting

  • Cincinnati Children's Medical Center

    Cincinnati, Ohio, 45267

    Brenda Poindexter, MD,MS

    Brenda Poindexter, MD

    Recruiting

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

    Cleveland, Ohio, 44106

    Michele C. Walsh, MD MS

    Michele C. Walsh, MD MS

    Recruiting

  • Research Institute at Nationwide Children's Hospital

    Columbus, Ohio, 43205

    Active, not recruiting

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75235

    Myra H Wyckoff, MD

    Myra H. Wyckfoff, MD

    Recruiting

  • Wayne State University

    Detroit, Michigan, 48201

    Seetha Shankaran, MD

    Seetha Shankaran, MD

    Recruiting

  • RTI International

    Durham, North Carolina, 27705

    Active, not recruiting

  • Duke University

    Durham, North Carolina, 27710

    C. Michael Cotten, MD

    C. Michael Cotten, MD

    Recruiting

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

    Jon Tyson, MD MPH

    Jon E. Tyson, MD MPH

    Recruiting

  • Indiana University

    Indianapolis, Indiana, 46202

    Greg Sokol, MD

    Greg Sokol, MD

    Recruiting

  • University of Iowa

    Iowa City, Iowa, 52242

    Edward F. Bell, MD

    Edward F. Bell, MD

    Recruiting

  • University of Mississippi Medical Center - Children's of Mississippi

    Jackson, Mississippi, 39216

    Abhay Bhatt, MD

    Abhay Bhatt, MD

    Not yet recruiting

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108

    William Truog, MD

    William Truog, MD

    Recruiting

  • University of California - Los Angeles

    Los Angeles, California, 90025

    Uday Devaskar, MD

    Uday Devaskar, MD

    Recruiting

  • University of Tennessee

    Memphis, Tennessee, 38163

    Completed

  • University of Miami

    Miami, Florida, 33136

    Completed

  • Yale University

    New Haven, Connecticut, 06504

    Completed

  • Stanford University

    Palo Alto, California, 94304

    Krisa P. Van Meurs, MD

    Krisa P. Van Meurs, MD

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Eric Eichenwald, MD

    Eric Eichenwald, MD

    Recruiting

  • Brown University, Women & Infants Hospital of Rhode Island

    Providence, Rhode Island, 02905

    Active, not recruiting

  • University of Rochester

    Rochester, New York, 14642

    Active, not recruiting

  • University of Utah

    Salt Lake City, Utah, 84108

    Bradley Yoder, MD

    Bradley Yoder, MD

    Recruiting

  • University of California at San Diego

    San Diego, California, 92103-8774

    Completed

  • Sharp Mary Birch Hospital for Women & Newborns

    San Diego, California, 92123

    Anup Katheria, MD

    Anup Katheria, MD

    Not yet recruiting

  • George Washington University

    Washington D.C., District of Columbia, 20052

    Completed

Other trials in United States

About this study

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.

Read the 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 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.

Being tested
No Intervention
Keywords
NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Prematurity, Neurodevelopmental Outcome, Follow up studies
Medical subject headings
Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No InterventionOther

    No Intervention

Study groups in NCT00009633
Study groupRoleWhat they receive
Registry CohortRegistry Cohort
Receives: Other: No Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Longitudinal database currently funded through 3/31/2016

Secondary outcomes (2)

  1. To examine the relationship between baseline characteristics and outcome

    Measured: Longitudinal database currently funded through 3/31/2016

  2. To provide data for hypothesis formulation and sample size calculation for Network multi-center studies

    Measured: Longitudinal database currently funded through 3/31/2016

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2001 (estimated)
  2. Study start1 Apr 1993
  3. Primary completion31 Mar 2030 (estimated)
  4. Study completion31 Mar 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
68,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00009633
Sponsor's protocol ID
NICHD-NRN-0007
Other IDs
U24HD095254, UG1HD068263, UG1HD034216, UG1HD021364, UG1HD027853, UG1HD027851, UG1HD053109, UG1HD112079
Acronym
FU
Status last verified
Jun 2026
First submitted
1 Feb 2001
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
No

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. doi: 10.1542/peds.2007-0423. Epub 2008 Apr 7.

    PubMed 18390958

  • 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.

    PubMed 16647401

  • 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.

    PubMed 17079582

  • 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.

    PubMed 15713907

  • 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.

    PubMed 19117897

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

    PubMed 16396864

  • 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.

    PubMed 19651577

  • 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.

    PubMed 16549503

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

    PubMed 17961693

  • Castro L, Yolton K, Haberman B, Roberto N, Hansen NI, Ambalavanan N, Vohr BR, Donovan EF. Bias in reported neurodevelopmental outcomes among extremely low birth weight survivors. Pediatrics. 2004 Aug;114(2):404-10. doi: 10.1542/peds.114.2.404.

    PubMed 15286223

  • 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.

    PubMed 19067285

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

    PubMed 18762491

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

    PubMed 19459909

  • 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.

    PubMed 14510321

  • 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.

    PubMed 16585322

Questions about this trial

What is this clinical trial studying?

An observational study of Infant, Newborn and Infant, Low Birth Weight, run by NICHD Neonatal Research Network at 31 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Susan R Hintz, MD, MS Epi (srhintz@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 3/31/2016). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00009633, which also lists 76 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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