Follow-up assessments for high-risk infants
Follow-up Visit of High Risk Infants
This study looks at how extremely low birth-weight infants develop by checking their motor skills, thinking, language, and behavior when they are about two years old, while also comparing them to healthy babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 68000 (estimated) |
| Ages | 18 Months to 26 Months |
| Sex | All |
| Sponsor | NICHD Neonatal Research Network Research network |
| Locations | 31 sites (Birmingham, Alabama and 30 other locations) |
| Trial ID | NCT00009633 on ClinicalTrials.gov |
What this trial studies
This observational study involves a multi-center cohort of surviving extremely low birth-weight infants who receive comprehensive neurodevelopmental, neurosensory, and functional assessments at 22-26 months corrected age. The study aims to identify maternal and neonatal risk factors that may influence neurodevelopment by evaluating motor skills, cognitive abilities, language, and behavior. It also collects data on growth, socioeconomic status, and the use of early intervention services. A reference group of healthy term infants will be assessed to minimize biases in evaluations.
Who should consider this trial
Good fit: Ideal candidates for this study are infants born at participating centers with a gestational age of less than 27 weeks.
Not a fit: Patients who are not extremely low birth-weight infants or those who do not meet the specific inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of neurodevelopmental outcomes in high-risk infants, leading to improved care and interventions.
How similar studies have performed: Other studies have shown success in assessing neurodevelopmental outcomes in similar high-risk populations, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Birmingham, Alabama and 30 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- University of California - Los Angeles — Los Angeles, California, United States (Recruiting)
- Stanford University — Palo Alto, California, United States (Recruiting)
- University of California at San Diego — San Diego, California, United States (Completed)
- Sharp Mary Birch Hospital for Women & Newborns — San Diego, California, United States (Not_yet_recruiting)
- Yale University — New Haven, Connecticut, United States (Completed)
- George Washington University — Washington D.C., District of Columbia, United States (Completed)
- University of Miami — Miami, Florida, United States (Completed)
- Emory University — Atlanta, Georgia, United States (Recruiting)
- Northwestern Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (Not_yet_recruiting)
- Indiana University — Indianapolis, Indiana, United States (Recruiting)
- University of Iowa — Iowa City, Iowa, United States (Recruiting)
- Tufts Medical Center — Boston, Massachusetts, United States (Completed)
- Harvard University — Cambridge, Massachusetts, United States (Completed)
- Wayne State University — Detroit, Michigan, United States (Recruiting)
- University of Mississippi Medical Center - Children's of Mississippi — Jackson, Mississippi, United States (Not_yet_recruiting)
- Children's Mercy Hospital — Kansas City, Missouri, United States (Recruiting)
- University of New Mexico — Albuquerque, New Mexico, United States (Recruiting)
- University of Rochester — Rochester, New York, United States (Active_not_recruiting)
- Wake Forest University — Charlotte, North Carolina, United States (Completed)
- RTI International — Durham, North Carolina, United States (Active_not_recruiting)
- Duke University — Durham, North Carolina, United States (Recruiting)
- Cincinnati Children's Medical Center — Cincinnati, Ohio, United States (Recruiting)
- Case Western Reserve University, Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States (Recruiting)
- Research Institute at Nationwide Children's Hospital — Columbus, Ohio, United States (Active_not_recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Brown University, Women & Infants Hospital of Rhode Island — Providence, Rhode Island, United States (Active_not_recruiting)
- University of Tennessee — Memphis, Tennessee, United States (Completed)
- University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States (Recruiting)
- University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)
- University of Utah — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Abbot R. Laptook, MD — Brown University, Women & Infants Hospital of Rhode Island
- Study coordinator: Susan R Hintz, MD, MS Epi
- Email: srhintz@stanford.edu
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.