Clinical trial NCT03407729: Measuring Brain Activity of School Age Children
Official title: Structure & Function of Dopaminergic Brain Networks Following Postnatally-Occurring Hypoxic Insults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perinatal Hypoxia
Dopamine
Neurobehavioral Manifestations
Keywords: Hypoxia, Brain
Neural networks
Magnetic Resonance Imaging
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 21
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study Group Children (n=11) will be drawn from a cohort currently maintained by the investigators.

Healthy Control Children will be recruited using various strategies: (1) study flyers given to the parents of the prematurely born cohort children to pass along to parents of other children with ages similar to their own child. (2) study flyers posted in the hospital's primary care pediatric clinics asking interested children/families to contact us to learn more about the study; (3) study flyers distributed by professional colleagues/pediatric physicians to potential candidate children/families meeting study inclusion criteria.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Structural Integrity of Dopaminergic Circuits
timeFrame: 30 minutes
measure: Functional Activity During Executive Function Tasks
timeFrame: 30 minutes
Secondary outcomes:
measure: Cognitive Performance-Fine Motor Function
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Michael J Decker, PhD
role: PRINCIPAL_INVESTIGATOR
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