Follow-up Visit of High Risk Infants

(FU Trial)

Recruiting at 22 trial locations

Overseen By Susan R Hintz, MD, MS Epi

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: NICHD Neonatal Research Network

Disqualifiers: Older than 27 weeks, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

68000 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Kristi L. Watterberg, MD

Principal Investigator

University of New Mexico

Carl T D'Angio, MD

Principal Investigator

University of Rochester

Michele C. Walsh, MD MS

Principal Investigator

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

Greg M. Sokol, MD

Principal Investigator

Indiana University

Abhik Das, PhD

Principal Investigator

RTI International

Uday Devaskar, MD

Principal Investigator

University of California, Los Angeles

Brenda B. Poindexter, MD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Waldemar A. Carlo, MD

Principal Investigator

University of Alabama at Birmingham

Edward F. Bell, MD

Principal Investigator

University of Iowa

Eric C Eichenwald, MD

Principal Investigator

University of Pennsylvania

Pablo J. Sanchez, MD

Principal Investigator

Research Institute at Nationwide Children's Hospital

David P. Carlton, MD

Principal Investigator

Emory University

Abbot R. Laptook, MD

Principal Investigator

Brown University, Women & Infants Hospital of Rhode Island

C. Michael Cotten, MD, MHS

Principal Investigator

Duke University

Myra H. Wyckoff, MD

Principal Investigator

University of Texas, Southwestern Medical Center at Dallas

Jon E Tyson, MD, MPH

Principal Investigator

The University of Texas Health Science Center, Houston

Bradley A. Yoder, MD

Principal Investigator

University of Utah

Seetha Shankaran, MD

Principal Investigator

Wayne State University

Krisa P. Van Meurs, MD

Principal Investigator

Stanford University

William E. Truog, MD

Principal Investigator

Children's Mercy Hospital Kansas City

Eligibility Criteria

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Assessment

Neurodevelopmental, neurosensory, and functional assessments at 22-26 months corrected age

1 visit

1 visit (in-person)

Follow-up

Participants are monitored for neurodevelopmental outcomes and potential risk factors

Long-term

Treatment Details

Interventions

• None

Participant Groups

Group I: Registry Cohort Experimental Treatment 1 Intervention

Registry Cohort

Who Is Running the Clinical Trial?

NICHD Neonatal Research Network

Lead Sponsor

Trials

62

Recruited

209,000+

National Center for Research Resources (NCRR)

Collaborator

Trials

540

Recruited

317,000+

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

Collaborator

Trials

2,103

Recruited

2,760,000+