Follow-up Study for High-Risk Infants
This is an observational study, meaning there are no interventions or treatments being tested. It's a follow-up study for infants born very prematurely (before 27 weeks gestational age) at specific Neonatal Research Network (NRN) centers. The study aims to understand how different factors during pregnancy and after birth might affect a baby's brain development. Researchers collect information on development of motor skills, thinking skills, language, and behavior when the children are between 18 and 26 months corrected age (this means their age adjusted for how premature they were). The goal is to identify potential risk factors and understand the long-term outcomes for these high-risk infants. The study is currently collecting data for a long-term registry.
- Study design
- This is an observational study with no intervention, planning to include 68,000 participants. It is a multi-center cohort study.
- What's involved
- Participants will undergo neurodevelopmental, neurosensory, and functional assessments at 22-26 months corrected age (or 18-22 months corrected age for infants born before July 1, 2012).
- Compensation
- Not stated in the trial record.
- Follow-up
- Data is being collected for a longitudinal database, currently funded through March 31, 2016.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Follow-up Visit of High Risk Infants
At a glance
Conditions
NCT00009633
Where you'd take part
This study runs at 31 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohiono site contact published
Recruiting
Children's Mercy Hospital
Kansas City, Missourino site contact published
Recruiting
Cincinnati Children's Medical Center
Cincinnati, Ohiono site contact published
Recruiting
Duke University
Durham, North Carolinano site contact published
Recruiting
Emory University
Atlanta, Georgiano site contact published
Recruiting
Indiana University
Indianapolis, Indianano site contact published
Recruiting
Northwestern Lurie Children's Hospital of Chicago
Chicago, Illinoisno site contact published
Not yet recruiting
Sharp Mary Birch Hospital for Women & Newborns
San Diego, Californiano site contact published
Not yet recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Abbot R. Laptook, MD · PRINCIPAL_INVESTIGATOR · Brown University, Women & Infants Hospital of Rhode Island
- Michele C. Walsh, MD MS · PRINCIPAL_INVESTIGATOR · Case Western Reserve University, Rainbow Babies and Children's Hospital
- C. Michael Cotten, MD, MHS · PRINCIPAL_INVESTIGATOR · Duke University
- David P. Carlton, MD · PRINCIPAL_INVESTIGATOR · Emory University
- Greg M. Sokol, MD · PRINCIPAL_INVESTIGATOR · Indiana University
- Abhik Das, PhD · PRINCIPAL_INVESTIGATOR · RTI International
- Krisa P. Van Meurs, MD · PRINCIPAL_INVESTIGATOR · Stanford University
- 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
- Kristi L. Watterberg, MD · PRINCIPAL_INVESTIGATOR · University of New Mexico
- 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
- William E. Truog, MD · PRINCIPAL_INVESTIGATOR · Children's Mercy Hospital Kansas City
- Pablo J. Sanchez, MD · PRINCIPAL_INVESTIGATOR · Research Institute at Nationwide Children's Hospital
- Uday Devaskar, MD · PRINCIPAL_INVESTIGATOR · University of California, Los Angeles
- Carl T D'Angio, MD · PRINCIPAL_INVESTIGATOR · University of Rochester
- Eric C Eichenwald, MD · PRINCIPAL_INVESTIGATOR · University of Pennsylvania
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform mannerLongitudinal database currently funded through 3/31/2016