Status:
COMPLETED
Measuring Brain Activity of School Age Children
Lead Sponsor:
Case Western Reserve University
Conditions:
Perinatal Hypoxia
Dopamine
Eligibility:
All Genders
8-15 years
Brief Summary
This observational study will investigate whether differences in birth events and oxygen levels during the newborn period affects the brain activity of children during the middle childhood years.
Detailed Description
The investigators will conduct an observational study comparing two groups of children to determine whether differences in birth events and oxygen levels during the newborn period lead to structural a...
Eligibility Criteria
Inclusion
- For Study Group Children: Birth gestational age between 23-28 weeks and birth weight appropriate for gestational age (AGA) with available oxygen saturation level data recorded continuously from the first day of life to 8 weeks postnatal age (n=11)
- For Healthy Control Children: Birth gestational age ≥ 38 weeks gestation and birth weight appropriate for term gestation (n=10) matched by age/sex/race to participating cohort children.
- Born in years 2005-2009 (age range will be 8-15 years during the funding period)
- Ability of the child to provide assent, with the parent/legal guardian able to provide written informed consent for study procedures.
- Sensory and motor capability to complete study tasks (i.e. Grooved Pegboard test). Mental Development index must be \> 80 at 2-year-old follow-up for preterm cohort.
Exclusion
- Past history of concussion requiring medical treatment to avoid confounding of MRI data
- Current diagnosis of autism.
- Child who suffers from claustrophobia (per parent report).
- Unable to participate in neuroimaging due to claustrophobia, or medical contraindication to MRI including any implanted medical device, dental braces, surgical clips for aneurysms in the head, heart valve prostheses, electrodes or other metallic objects, pregnancy.
- Healthy control children who were treated in the Neonatal ICU in the newborn period for breathing difficulties.
- Healthy control children who were hospitalized for breathing problems in the first 3 months of infancy.
Key Trial Info
Start Date :
June 8 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 17 2020
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03407729
Start Date
June 8 2018
End Date
February 17 2020
Last Update
October 10 2022
Active Locations (1)
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1
Case Western Reserve University
Cleveland, Ohio, United States, 44106