68000 Participants Needed

Follow-Up Visits for Premature Infants

(FU Trial)

Recruiting at 22 trial locations
AD
SR
Overseen BySusan R Hintz, MD, MS Epi
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: NICHD Neonatal Research Network
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the early development of infants born extremely small and early. Researchers seek to identify factors during pregnancy and shortly after birth that might influence the growth and development of these infants, particularly regarding brain and sensory functions. The study involves no treatments; it focuses solely on gathering information. It suits infants born at specific hospitals before 27 weeks of pregnancy who are already participating in related studies. As an unphased study, this trial provides families with a unique opportunity to contribute to vital research that could enhance future care for extremely premature infants.

Do I need to stop my current medications for the trial?

The trial information does not specify whether participants need to stop taking their current medications.

Why are researchers excited about this trial?

Researchers are excited about the "Follow-up Visit of High Risk Infants" trial because it aims to gather crucial long-term data on infants considered at high risk, something that current treatment options do not typically address. Unlike traditional approaches that focus on immediate treatment, this trial emphasizes understanding the developmental trajectory and health outcomes of these infants over time. By collecting detailed information through a registry cohort, researchers hope to uncover patterns and insights that could lead to improved care strategies and early interventions, potentially transforming how we support high-risk infants in the future.

Who Is on the Research Team?

EF

Edward F. Bell, MD

Principal Investigator

University of Iowa

BB

Brenda B. Poindexter, MD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

WA

Waldemar A. Carlo, MD

Principal Investigator

University of Alabama at Birmingham

PJ

Pablo J. Sanchez, MD

Principal Investigator

Research Institute at Nationwide Children's Hospital

AD

Abhik Das, PhD

Principal Investigator

RTI International

UD

Uday Devaskar, MD

Principal Investigator

University of California, Los Angeles

EC

Eric C Eichenwald, MD

Principal Investigator

University of Pennsylvania

KL

Kristi L. Watterberg, MD

Principal Investigator

University of New Mexico

GM

Greg M. Sokol, MD

Principal Investigator

Indiana University

MC

Michele C. Walsh, MD MS

Principal Investigator

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

CT

Carl T D'Angio, MD

Principal Investigator

University of Rochester

DP

David P. Carlton, MD

Principal Investigator

Emory University

AR

Abbot R. Laptook, MD

Principal Investigator

Brown University, Women & Infants Hospital of Rhode Island

CM

C. Michael Cotten, MD, MHS

Principal Investigator

Duke University

MH

Myra H. Wyckoff, MD

Principal Investigator

University of Texas, Southwestern Medical Center at Dallas

JE

Jon E Tyson, MD, MPH

Principal Investigator

The University of Texas Health Science Center, Houston

BA

Bradley A. Yoder, MD

Principal Investigator

University of Utah

SS

Seetha Shankaran, MD

Principal Investigator

Wayne State University

KP

Krisa P. Van Meurs, MD

Principal Investigator

Stanford University

WE

William E. Truog, MD

Principal Investigator

Children's Mercy Hospital Kansas City

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • None
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Registry CohortExperimental Treatment1 Intervention

Find a Clinic Near You

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+
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