NCT03407729

Measuring Brain Activity of School Age Children

Completed Results posted Last updated 10 October 2022

What this trial tests

trial testing Magnetic Resonance Imaging in Perinatal Hypoxia in 21 participants. Completed in 17 February 2020.

Timeline

8 June 2018

Primary endpoint
17 February 2020

17 February 2020

Quick facts

Lead sponsor	Case Western Reserve University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	21
Start date	8 June 2018
Primary completion	17 February 2020
Estimated completion	17 February 2020
Sites	1 location across United States

Drugs / interventions tested

• Magnetic Resonance Imaging
• Cognitive Performance Testing

Conditions studied

• Perinatal Hypoxia — all drugs for Perinatal Hypoxia →
• Dopamine — all drugs for Dopamine →
• Neurobehavioral Manifestations — all drugs for Neurobehavioral Manifestations →

Sponsor

Case Western Reserve University

Who can join

Adults 8 to 15, any sex, with Perinatal Hypoxia or Dopamine. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Structural Integrity of Dopaminergic Circuits Primary · 30 minutes

Assessment of dopaminergic circuits originating in the substantia nigra pars compacta (SNpc) and ventral tegmental area (VTA). Includes right and left nucleus accumbens, right and left mamillary body, right and left hippocampus. Measured using Magnetic Resonance T1-weighted magnetization prepared rapid gradient echo (MPRAGE) scans with three-dimensional volumetrics analysis

left nucleus accumbens

Group	Value	95% CI
Post-hypoxic Former Preterm	148.90	± 50.12
Healthy Term-born Children	175.93	± 25.41

right nucleus accumbens

Group	Value	95% CI
Post-hypoxic Former Preterm	177.25	± 31.46
Healthy Term-born Children	192.78	± 16.48

left mamillary body

Group	Value	95% CI
Post-hypoxic Former Preterm	89.34	± 18.18
Healthy Term-born Children	54.78	± 18.02

right mamillary body

Group	Value	95% CI
Post-hypoxic Former Preterm	67.78	± 17.34
Healthy Term-born Children	44.70	± 15.03

left hippocampus

Group	Value	95% CI
Post-hypoxic Former Preterm	2741.09	± 511.83
Healthy Term-born Children	3419.48	± 619.00

right hippocampus

Group	Value	95% CI
Post-hypoxic Former Preterm	3329.34	± 682.48
Healthy Term-born Children	4241.03	± 659.36

Functional Activity During Executive Function Tasks Primary · 30 minutes

Subjects in each group were evaluated for changes in functional connectivity between the substantia nigra pars compacta (SNpc) and ventral tegmental area (VTA), as evaluated by functional magnetic resonance imaging blood oxygen level dependent (fMRI-BOLD), using whole brain analysis. The measurement is increase/decrease of MRI signal intensity in a given region, thresholded at p \<0.05, summarized into a value representing 'size of region of increase' or 'size of region of decrease' after subjects' scans were combined/mapped onto a standard MNI brain. Only clusters of over 50 voxels were inclu

Left thalamus

Group	Value	95% CI
Post-hypoxic Former Preterm	310
Healthy Term-born Children	358

Left middle temporal gyrus

Group	Value	95% CI
Post-hypoxic Former Preterm	95
Healthy Term-born Children	75

Cognitive Performance-Fine Motor Function Secondary · 20 minutes

Measured using the grooved pegboard task (number of seconds required to place 25 pegs using the dominant hand)

Group	Value	95% CI
Post-hypoxic Former Preterm	102.11	± 42.77
Healthy Term-born Children	82.71	± 15.59

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.