Actively Recruiting

Age: 18Months - 26Months
All Genders
ID00009633

Follow-up Visit of High Risk Infants in the NICHD Neonatal Research Network

Led by NICHD Neonatal Research Network · Updated on 2025-02-13

68000

Participants Needed

31

Research Sites

N/A

Total Duration

On this page

Sponsors

N

NICHD Neonatal Research Network

Lead Sponsor

N

National Center for Research Resources (NCRR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are conducting a multi-center cohort study through the NICHD Neonatal Research Network to follow up on surviving extremely low birth-weight infants. The study aims to identify maternal and neonatal risk factors affecting neurodevelopment by assessing motor skills, cognitive and language development, behavior, mortality, medical conditions, growth, socioeconomic impacts, and the use of support services. A sub-study also includes healthy term infants as a reference group to improve assessment accuracy and monitor scoring consistency over time. Participants undergo neurodevelopmental, neurosensory, and functional assessments at 22-26 months corrected age, with infants born before July 1, 2012, assessed at 18-22 months. Evaluations collect demographic, socioeconomic, medical history, medication use, growth data, detailed neurologic exams, and standardized developmental scales such as the Bayley Scales of Infant Development and the Child Behavior Checklist. The study involves no interventions, focusing solely on observational data collection. During the study, data is gathered uniformly to maintain a registry of baseline and outcome information for very low birth-weight infants. Researchers examine relationships between initial characteristics and outcomes to support future study planning. The follow-up includes detailed developmental testing and monitoring for use of early intervention services. The participation period spans up to 26 months of corrected age, with ongoing data collection to guide neurodevelopmental care for this high-risk population.

CONDITIONS

Brief Title

Follow-up Visit of High Risk Infants

Who Can Participate

Age: 18Months - 26Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Infants born at participating NICHD Neonatal Research Network centers
  • Born before 27 weeks gestational age
  • Infants enrolled in one or more additional NICHD NRN Follow-up studies may be included if they do not meet the above criteria
  • Infants up to 26 months corrected age at assessment (18-22 months for those born before July 1, 2012)
Not Eligible

You will not qualify if you...

  • Infants not born at participating centers unless enrolled in additional NICHD follow-up studies
  • Infants born at or after 27 weeks gestational age unless part of other NICHD follow-up trials
  • Infants not meeting weight or gestational age criteria without enrollment in other trials
  • Infants outside the specified corrected age range for assessment unless otherwise included in other studies or trials

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Long-term Monitoring

Duration - At 22 to 26 months corrected age

Participants undergo neurodevelopmental, neurosensory, and functional assessments including evaluations of motor skills, cognitive skills, language, behavior, medical history, and growth data at 22-26 months corrected age.

1 to 2 visits depending on assessment timing

Trial Site Locations

Total: 31 locations

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35233

Actively Recruiting

2

University of California - Los Angeles

Los Angeles, California, United States, 90025

Actively Recruiting

3

Stanford University

Palo Alto, California, United States, 94304

Actively Recruiting

4

University of California at San Diego

San Diego, California, United States, 92103-8774

Completed

5

Sharp Mary Birch Hospital for Women & Newborns

San Diego, California, United States, 92123

Not Yet Recruiting

6

Yale University

New Haven, Connecticut, United States, 06504

Completed

7

George Washington University

Washington D.C., District of Columbia, United States, 20052

Completed

8

University of Miami

Miami, Florida, United States, 33136

Completed

9

Emory University

Atlanta, Georgia, United States, 30303

Actively Recruiting

10

Northwestern Lurie Children's Hospital of Chicago

Chicago, Illinois, United States, 60611

Not Yet Recruiting

11

Indiana University

Indianapolis, Indiana, United States, 46202

Actively Recruiting

12

University of Iowa

Iowa City, Iowa, United States, 52242

Actively Recruiting

13

Tufts Medical Center

Boston, Massachusetts, United States, 02111

Completed

14

Harvard University

Cambridge, Massachusetts, United States, 02138

Completed

15

Wayne State University

Detroit, Michigan, United States, 48201

Actively Recruiting

16

University of Mississippi Medical Center - Children's of Mississippi

Jackson, Mississippi, United States, 39216

Not Yet Recruiting

17

Children's Mercy Hospital

Kansas City, Missouri, United States, 64108

Actively Recruiting

18

University of New Mexico

Albuquerque, New Mexico, United States, 87131

Actively Recruiting

19

University of Rochester

Rochester, New York, United States, 14642

Active, Not Recruiting

20

Wake Forest University

Charlotte, North Carolina, United States, 27157

Completed

21

RTI International

Durham, North Carolina, United States, 27705

Active, Not Recruiting

22

Duke University

Durham, North Carolina, United States, 27710

Actively Recruiting

23

Cincinnati Children's Medical Center

Cincinnati, Ohio, United States, 45267

Actively Recruiting

24

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

Cleveland, Ohio, United States, 44106

Actively Recruiting

25

Research Institute at Nationwide Children's Hospital

Columbus, Ohio, United States, 43205

Active, Not Recruiting

26

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

27

Brown University, Women & Infants Hospital of Rhode Island

Providence, Rhode Island, United States, 02905

Active, Not Recruiting

28

University of Tennessee

Memphis, Tennessee, United States, 38163

Completed

29

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States, 75235

Actively Recruiting

30

University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030

Actively Recruiting

31

University of Utah

Salt Lake City, Utah, United States, 84108

Actively Recruiting

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Research Team

S

Susan R Hintz, MD, MS Epi

A

Abhik Das, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Neurodevelopmental outcome of extremely low birth weight infants with posthemorrhagic hydrocephalus requiring shunt insertion.

Ira Adams-Chapman, Nellie I Hansen, Barbara J Stoll...

https://pubmed.ncbi.nlm.nih.gov/18390958

Using a count of neonatal morbidities to predict poor outcome in extremely low birth weight infants: added role of neonatal infection.

Dirk Bassler, Barbara J Stoll, Barbara Schmidt...

https://pubmed.ncbi.nlm.nih.gov/19117897

Neonatal candidiasis among extremely low birth weight infants: risk factors, mortality rates, and neurodevelopmental outcomes at 18 to 22 months.

Daniel K Benjamin, Barbara J Stoll, Avory A Fanaroff...

https://pubmed.ncbi.nlm.nih.gov/16396864

Laparotomy versus peritoneal drainage for necrotizing enterocolitis or isolated intestinal perforation in extremely low birth weight infants: outcomes through 18 months adjusted age.

Martin L Blakely, Jon E Tyson, Kevin P Lally...

https://pubmed.ncbi.nlm.nih.gov/16549503

Clinical data predict neurodevelopmental outcome better than head ultrasound in extremely low birth weight infants.

Eduardo Broitman, Namasivayam Ambalavanan, Rosemary D Higgins...

https://pubmed.ncbi.nlm.nih.gov/17961693