N/A
N=21
Measuring Brain Activity of School Age Children
Perinatal Hypoxia · Dopamine · Neurobehavioral Manifestations
Bottom Line
View on ClinicalTrials.gov: NCT03407729 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcome: Primary: Structural Integrity of Dopaminergic Circuits — 148.90; 175.93; 177.25; 192.78 mm^3
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Magnetic Resonance Imaging (Other); Cognitive Performance Testing (Other)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- Case Western Reserve University
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Structural Integrity of Dopaminergic Circuits |
148.90; 175.93; 177.25; 192.78; 89.34; 54.78 | — |
| PRIMARY Functional Activity During Executive Function Tasks |
310; 358; 95; 75 | <0.05 sig |
| SECONDARY Cognitive Performance-Fine Motor Function |
102.11; 82.71 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03407729). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.