Follow-up assessments for high-risk infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

* 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 it's running

• 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
• Emory University
  Atlanta, Georgia, United States Recruiting
• Indiana University
  Indianapolis, Indiana, United States Recruiting
• University of Iowa
  Iowa City, Iowa, 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.