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Completed

NCT Number: NCT03407729

Measuring Brain Activity of School Age Children

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.

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Key information

Age range

8 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnetic Resonance Imaging

Other

MRI uses a strong magnetic field and radio waves to create detailed images of the brain while the person's head is positioned inside a round tunnel.

Other names: T-1 MPRAGE, fMRI-BOLD

Cognitive Performance Testing

Other

For the Grooved Pegboard task: After the MRI scan, children will be timed as they place pegs into holes with randomly positioned slots.

Other names: Grooved pegboard task

Primary outcomes

  1. Structural Integrity of Dopaminergic Circuits

    Time frame: 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

  2. Functional Activity During Executive Function Tasks

    Time frame: 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 included, and the size of the region is reported in voxel size. The averaged brains for prematurely born fMRI was subtracted from the full term treatment for each group, and then these averaged differences were subtracted from each other. While other areas of the brain met threshold criteria in the analysis, only brain regions innervated by primary or collateral dopaminergic pathways are reported.

Secondary outcomes

  1. Cognitive Performance-Fine Motor Function

    Time frame: 20 minutes

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

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Registry information

Official study title

Structure & Function of Dopaminergic Brain Networks Following Postnatally-Occurring Hypoxic Insults

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 23, 2018
Registry last updated
Oct 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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