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Neonatal Biomarkers in Extremely Preterm Babies Predict Childhood Brain Disorders (ELGAN-2)



The National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, is looking for individuals to participate in clinical studies.  Participating in clinical trials allows you to play an active role in research on the nature and causes of many disorders of the brain and nervous system, and to possibly help physician-scientists develop future treatments.  The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible.

Description:

The purpose of this study is to learn more about children who were born extremely prematurely.  Researchers specifically want to know if events or measurement in the placenta or blood soon after these children were born help predict and understand why these children are more likely to have more difficulty than expected in terms of learning, communicating, and socializing.

Nearly one half of the 30,000 infants born in the United States at an extremely low gestational age (ELGAN) have moderate or severe neurodevelopmental disabilities.  The ELGAN-2 study builds on a previous, prospective study—called ELGAN-1—of nearly 1000 children born before 28 weeks of gestation or more than 3 months early.  The ELGAN-1 study evaluated the children at birth and again at 2 years of age and found that at age 2, 11 percent had cerebral palsy, 40 percent had a developmental quotient below 70, and 11 percent had microcephaly.  Additionally, among children without motor, visual, or hearing deficits, 16 percent screened positive for autism spectrum disorders.

In ELGAN-2, researchers will evaluate approximately 966 participants from the earlier study, at age 9 and will assess their neuropsychological and neurocognitive function, measure head circumference, quantify motor impairment, and perform brain magnetic resonance imaging (MRI) in some of the children.  Participants will be given standard tests that measure intelligence and language skills as well as other abilities including the ability to pay attention, hand-eye coordination, math abilities, what he/she has learned, and social skills.  Parents will be asked various questions including information about their child’s developmental, educational, and medical history.  Based on these assessments, some participants may be asked to have additional autism diagnostic assessments.  The results of these various assessments will be considered in light of the events and measurement in the placenta or blood soon after these children were born.

Participants will be asked to partake in a 3-hour study, however, participation may be extended if additional time is needed for autism testing.  Those who undergo a brain MRI will return for an added hour of study on another day.

Results from this study may help scientists develop new treatments for children born extremely prematurely.

Phase: 

N/A

Eligibility Criteria:

Inclusion:

  • Must have been a participant in the ELGAN-1 study.
  • Must be 9 years, 9 months old.

Study Design: 

Observational, Prospective

Study Locations: 

Multiple US locations

For more information:

Contact:  Julie Rollins, MA; telephone: (617) 414-6879; email: julie.rollins@bmc.org;

Last Reviewed July 18, 2014