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Measuring Brain Activity of School Age Children

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Case Western Reserve University

Status

Completed

Conditions

Perinatal Hypoxia
Neurobehavioral Manifestations
Dopamine

Treatments

Other: Cognitive Performance Testing
Other: Magnetic Resonance Imaging

Study type

Observational

Funder types

Other

Identifiers

NCT03407729
12266077
05-17-23 (Other Identifier)

Details and patient eligibility

About

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.

Full 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 and functional impairment within the brain's dopaminergic pathways and the cortical regions innervated by those pathways. The dopaminergic system is involved in modulating motor control and cognitive function.

Using magnetic resonance diffusion tensor imaging, structural integrity of dopaminergic circuits will be quantified and compared in post-hypoxic former preterm children versus healthy control children born at term closely matched by age/sex/race.

Functional activity during executive function tasks will be quantified and compared in post-hypoxic former preterm children versus healthy control children born at term using functional magnetic resonance imaging-blood oxygen level dependent (fMRI-BOLD). Assessment of motor function (grooved pegboard task) will also be performed.

Enrollment

21 patients

Sex

All

Ages

8 to 15 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. 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)
  2. 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.
  3. Born in years 2005-2009 (age range will be 8-15 years during the funding period)
  4. Ability of the child to provide assent, with the parent/legal guardian able to provide written informed consent for study procedures.
  5. 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 criteria

  1. Past history of concussion requiring medical treatment to avoid confounding of MRI data
  2. Current diagnosis of autism.
  3. Child who suffers from claustrophobia (per parent report).
  4. 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.
  5. Healthy control children who were treated in the Neonatal ICU in the newborn period for breathing difficulties.
  6. Healthy control children who were hospitalized for breathing problems in the first 3 months of infancy.

Trial design

21 participants in 2 patient groups

Post-hypoxic former preterm
Description:
Born in the years 2005-2009 with birth gestational age between 23-28 weeks and birth weight appropriate for gestational age (AGA). Part of a research cohort with available oxygen saturation level data recorded continuously from the first day of life to 8 weeks postnatal age (n=11).Children will undergo Magnetic Resonance Imaging and Cognitive Performance Testing.
Treatment:
Other: Magnetic Resonance Imaging
Other: Cognitive Performance Testing
Healthy term-born children
Description:
Born in the years 2005-2009 with birth gestational age ≥ 38 weeks gestation and birth weight appropriate for term gestation (n=10) matched by age/sex/race to participating cohort children with no history of respiratory difficulty suggesting hypoxic exposure. Children will undergo Magnetic Resonance Imaging and Cognitive Performance Testing.
Treatment:
Other: Magnetic Resonance Imaging
Other: Cognitive Performance Testing

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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