Perinatal HypoxiaNCT03407729

Measuring Brain Activity of School Age Children

An observational study of Perinatal Hypoxia and Dopamine, run by Case Western Reserve University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 8 to 15 yearsHealthy volunteers can take part
Conditions the study is for: Perinatal Hypoxia, Dopamine, Neurobehavioral Manifestations
What is being tested?: Magnetic Resonance Imaging and Cognitive Performance Testing
How many people: 21 participants
Where: 1 siteUnited States
Study dates: 8 Jun 2018to 17 Feb 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 8 to 15 years
All sexes
Healthy volunteers accepted
Child

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.

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Case Western Reserve University
Cleveland, Ohio, 44106

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Perinatal Hypoxia, Dopamine, Neurobehavioral Manifestations
Being tested: Magnetic Resonance Imaging, Cognitive Performance Testing
Keywords: Hypoxia, Brain, Neural networks, Magnetic Resonance Imaging
Medical subject headings: Neurobehavioral Manifestations, Hypoxia, Brain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Magnetic Resonance ImagingOther
Also called T-1 MPRAGE, fMRI-BOLD
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.
Cognitive Performance TestingOther
Also called Grooved pegboard task
For the Grooved Pegboard task: After the MRI scan, children will be timed as they place pegs into holes with randomly positioned slots.

Study groups in NCT03407729
Study group	Role	What they receive
Post-hypoxic former preterm		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. Receives: Other: Magnetic Resonance Imaging; Other: Cognitive Performance Testing
Healthy term-born children		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. Receives: Other: Magnetic Resonance Imaging; Other: Cognitive Performance Testing

What is being measured

The primary outcome is the main question the study is designed to answer.

Structural Integrity of Dopaminergic Circuits
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
Measured: 30 minutes
Functional Activity During Executive Function Tasks
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.
Measured: 30 minutes

Secondary outcomes (1)

Cognitive Performance-Fine Motor Function
Measured using the grooved pegboard task (number of seconds required to place 25 pegs using the dominant hand)
Measured: 20 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jun 201817 Feb 2020

First posted23 Jan 2018
Study start8 Jun 2018
Primary completion17 Feb 2020
Study completion17 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (20)Papers the sponsor has linked to this study.
Other trials for Perinatal HypoxiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03407729
Sponsor's protocol ID: 12266077
Other IDs: 05-17-23
Status last verified: Oct 2022
First submitted: 16 Jan 2018
Last updated: 10 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: Because this is a vulnerable population and a small sample size from a known cohort of children, it is unclear of the institutional requirements for sharing individual participant data in any format other than peer-reviewed publications. The investigators will make datasets from this study available upon completion of the study. Those who are interested will submit a brief research plan to the Principal Investigators. Qualified investigators whose research question can be appropriately addressed by the requested dataset will be invited to discuss their plan and finalize details with the investigators via phone or in person.

Publications

Poets CF, Samuels MP, Southall DP. Epidemiology and pathophysiology of apnoea of prematurity. Biol Neonate. 1994;65(3-4):211-9. doi: 10.1159/000244055.
PubMed 8038285
Huppi PS, Murphy B, Maier SE, Zientara GP, Inder TE, Barnes PD, Kikinis R, Jolesz FA, Volpe JJ. Microstructural brain development after perinatal cerebral white matter injury assessed by diffusion tensor magnetic resonance imaging. Pediatrics. 2001 Mar;107(3):455-60. doi: 10.1542/peds.107.3.455.
PubMed 11230582
Inder TE, Volpe JJ. Mechanisms of perinatal brain injury. Semin Neonatol. 2000 Feb;5(1):3-16. doi: 10.1053/siny.1999.0112.
PubMed 10802746
Poets CF, Roberts RS, Schmidt B, Whyte RK, Asztalos EV, Bader D, Bairam A, Moddemann D, Peliowski A, Rabi Y, Solimano A, Nelson H; Canadian Oxygen Trial Investigators. Association Between Intermittent Hypoxemia or Bradycardia and Late Death or Disability in Extremely Preterm Infants. JAMA. 2015 Aug 11;314(6):595-603. doi: 10.1001/jama.2015.8841.
PubMed 26262797
Janvier A, Khairy M, Kokkotis A, Cormier C, Messmer D, Barrington KJ. Apnea is associated with neurodevelopmental impairment in very low birth weight infants. J Perinatol. 2004 Dec;24(12):763-8. doi: 10.1038/sj.jp.7211182.
PubMed 15329741
Perna R, Cooper D. Perinatal cyanosis: long-term cognitive sequelae and behavioral consequences. Appl Neuropsychol Child. 2012;1(1):48-52. doi: 10.1080/09084282.2011.643946.
PubMed 23428277
Smith TF, Schmidt-Kastner R, McGeary JE, Kaczorowski JA, Knopik VS. Pre- and Perinatal Ischemia-Hypoxia, the Ischemia-Hypoxia Response Pathway, and ADHD Risk. Behav Genet. 2016 May;46(3):467-77. doi: 10.1007/s10519-016-9784-4. Epub 2016 Feb 26.
PubMed 26920003
Decker MJ, Hue GE, Caudle WM, Miller GW, Keating GL, Rye DB. Episodic neonatal hypoxia evokes executive dysfunction and regionally specific alterations in markers of dopamine signaling. Neuroscience. 2003;117(2):417-25. doi: 10.1016/s0306-4522(02)00805-9.
PubMed 12614682
Decker MJ, Jones KA, Solomon IG, Keating GL, Rye DB. Reduced extracellular dopamine and increased responsiveness to novelty: neurochemical and behavioral sequelae of intermittent hypoxia. Sleep. 2005 Feb;28(2):169-76. doi: 10.1093/sleep/28.2.169.
PubMed 16171240
Decker MJ, Jones KA, Keating GL, Rye DB. Postnatal hypoxia evokes persistent changes within the male rat's dopaminergic system. Sleep Breath. 2018 May;22(2):547-554. doi: 10.1007/s11325-017-1558-6. Epub 2017 Aug 22.
PubMed 28828549
Rocha-Ferreira E, Hristova M. Plasticity in the Neonatal Brain following Hypoxic-Ischaemic Injury. Neural Plast. 2016;2016:4901014. doi: 10.1155/2016/4901014. Epub 2016 Mar 7.
PubMed 27047695
Nyakas C, Buwalda B, Luiten PG. Hypoxia and brain development. Prog Neurobiol. 1996 May;49(1):1-51. doi: 10.1016/0301-0082(96)00007-x.
PubMed 8817697
Stollstorff M, Foss-Feig J, Cook EH Jr, Stein MA, Gaillard WD, Vaidya CJ. Neural response to working memory load varies by dopamine transporter genotype in children. Neuroimage. 2010 Nov 15;53(3):970-7. doi: 10.1016/j.neuroimage.2009.12.104. Epub 2010 Jan 4.
PubMed 20053379
Langer N, von Bastian CC, Wirz H, Oberauer K, Jancke L. The effects of working memory training on functional brain network efficiency. Cortex. 2013 Oct;49(9):2424-38. doi: 10.1016/j.cortex.2013.01.008. Epub 2013 Jan 31.
PubMed 23489778
Allin MP, Kontis D, Walshe M, Wyatt J, Barker GJ, Kanaan RA, McGuire P, Rifkin L, Murray RM, Nosarti C. White matter and cognition in adults who were born preterm. PLoS One. 2011;6(10):e24525. doi: 10.1371/journal.pone.0024525. Epub 2011 Oct 12.
PubMed 22022357

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Neuro-MoD: Neuroplasticity With Motor Development
Perinatal Brain Injury
Recruiting
The HIEnome Study: Genome Sequencing for Perinatal HIE
Hypoxic Ischemic Encephalopathy of Newborn, Hypoxic Ischemic Encephalopathy
Not yet recruitingPhase 2/3
Intranasal Stem Cells to Treat Perinatal Brain Injury to Combat Cerebral Palsy
Perinatal Arterial Ischemic Stroke, Perinatal Asphyxia
RecruitingObservational study
Baby Brain Recovery Study
Perinatal Stroke
Not yet recruitingPhase 1/2
Mesenchymal Stem Cells With Cooling Therapy for Infants With Hypoxic-Ischemic Encephalopathy
Hypoxic-Ischemic Encephalopathy, Neonatal, Brain Injuries, Hypoxic-Ischemic

All Perinatal Hypoxia trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Structure & Function of Dopaminergic Brain Networks Following Postnatally-Occurring Hypoxic Insults
ClinicalTrials.gov ID: NCT03407729
Acronym / sponsor ID: 12266077
Conditions: Perinatal Hypoxia, Dopamine, Neurobehavioral Manifestations
Keywords: Hypoxia, Brain, Neural networks, Magnetic Resonance Imaging
Study type: Observational
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Case Western Reserve UniversityUniversity, hospital or other
Study start: 8 Jun 2018 (actual)
Primary completion: 17 Feb 2020 (actual)
Study completion: 17 Feb 2020 (actual)
First posted: 23 Jan 2018 (actual)
Results: Posted 10 Oct 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Post-hypoxic former preterm	–	Other: Magnetic Resonance Imaging, Other: Cognitive Performance TestingBorn 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.
Healthy term-born children	–	Other: Magnetic Resonance Imaging, Other: Cognitive Performance TestingBorn 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.

Who may qualify

Ages: 8 to 15 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child
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.

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Magnetic Resonance ImagingAlso: T-1 MPRAGE, fMRI-BOLDMRI 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	Healthy term-born children, Post-hypoxic former preterm
Cognitive Performance TestingAlso: Grooved pegboard taskFor the Grooved Pegboard task: After the MRI scan, children will be timed as they place pegs into holes with randomly positioned slots.	Other	Healthy term-born children, Post-hypoxic former preterm

Primary outcome

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
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.

1 secondary outcome

Cognitive Performance-Fine Motor Function
Time frame: 20 minutes

Results and safety

Results posted to the registry on 10 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Post-hypoxic Former Preterm	11	9
Healthy Term-born Children	10	7

Primary outcome: Structural Integrity of Dopaminergic Circuits

Time frame: 30 minutes. Mean (Standard Deviation). Unit: mm^3

Measure	Post-hypoxic Former Preterm n = 9	Healthy Term-born Children n = 7
left nucleus accumbens	148.90 (50.12)	175.93 (25.41)
right nucleus accumbens	177.25 (31.46)	192.78 (16.48)
left mamillary body	89.34 (18.18)	54.78 (18.02)
right mamillary body	67.78 (17.34)	44.70 (15.03)
left hippocampus	2741.09 (511.83)	3419.48 (619.00)
right hippocampus	3329.34 (682.48)	4241.03 (659.36)

Population analysed: All participants who had a usable structural magnetic resonance imaging (MRI) scan

Primary outcome: Functional Activity During Executive Function Tasks

Time frame: 30 minutes. Number. Unit: Cluster size (voxels)

Measure	Post-hypoxic Former Preterm n = 7	Healthy Term-born Children n = 6
Left thalamus	310	358
Left middle temporal gyrus	95	75

Post-hypoxic Former Preterm vs Healthy Term-born Children: p <0.05, t-test, 2 sided

Population analysed: All participants who met criteria for a technically acceptable functional magnetic resonance imaging scan (less than 3mm movement artifact) were included in these analyses. FSL (FMRIB Software Library)-defined cluster sizes greater than 50 voxels, with p\<0.05, within cognitive areas of interest are included in the outcome table. That table provides the number of voxels in clusters that showed increased or decreased connectivity.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 week. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Post-hypoxic Former Preterm	0 of 9 (0%)	0 of 9 (0%)	0 of 9
Healthy Term-born Children	0 of 7 (0%)	0 of 7 (0%)	0 of 7

Limitations and caveats (from the sponsor): Insufficient numbers of children studied due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic research shut-down. When research protocols were permitted to resume, parents were reluctant to bring children for a voluntary research study. Data collection also terminated early for technical reasons; the magnetic resonance imaging (MRI) scanner was replaced during the pandemic shut-down with a different model that did not produce comparable results to the earlier scans.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 8038285Poets CF, Samuels MP, Southall DP. Epidemiology and pathophysiology of apnoea of prematurity. Biol Neonate. 1994;65(3-4):211-9. doi: 10.1159/000244055.
Background: PubMed 11230582Huppi PS, Murphy B, Maier SE, Zientara GP, Inder TE, Barnes PD, Kikinis R, Jolesz FA, Volpe JJ. Microstructural brain development after perinatal cerebral white matter injury assessed by diffusion tensor magnetic resonance imaging. Pediatrics. 2001 Mar;107(3):455-60. doi: 10.1542/peds.107.3.455.
Background: PubMed 10802746Inder TE, Volpe JJ. Mechanisms of perinatal brain injury. Semin Neonatol. 2000 Feb;5(1):3-16. doi: 10.1053/siny.1999.0112.
Background: PubMed 26262797Poets CF, Roberts RS, Schmidt B, Whyte RK, Asztalos EV, Bader D, Bairam A, Moddemann D, Peliowski A, Rabi Y, Solimano A, Nelson H; Canadian Oxygen Trial Investigators. Association Between Intermittent Hypoxemia or Bradycardia and Late Death or Disability in Extremely Preterm Infants. JAMA. 2015 Aug 11;314(6):595-603. doi: 10.1001/jama.2015.8841.
Background: PubMed 15329741Janvier A, Khairy M, Kokkotis A, Cormier C, Messmer D, Barrington KJ. Apnea is associated with neurodevelopmental impairment in very low birth weight infants. J Perinatol. 2004 Dec;24(12):763-8. doi: 10.1038/sj.jp.7211182.
Background: PubMed 23428277Perna R, Cooper D. Perinatal cyanosis: long-term cognitive sequelae and behavioral consequences. Appl Neuropsychol Child. 2012;1(1):48-52. doi: 10.1080/09084282.2011.643946.
Background: PubMed 26920003Smith TF, Schmidt-Kastner R, McGeary JE, Kaczorowski JA, Knopik VS. Pre- and Perinatal Ischemia-Hypoxia, the Ischemia-Hypoxia Response Pathway, and ADHD Risk. Behav Genet. 2016 May;46(3):467-77. doi: 10.1007/s10519-016-9784-4. Epub 2016 Feb 26.
Background: PubMed 12614682Decker MJ, Hue GE, Caudle WM, Miller GW, Keating GL, Rye DB. Episodic neonatal hypoxia evokes executive dysfunction and regionally specific alterations in markers of dopamine signaling. Neuroscience. 2003;117(2):417-25. doi: 10.1016/s0306-4522(02)00805-9.
Background: PubMed 16171240Decker MJ, Jones KA, Solomon IG, Keating GL, Rye DB. Reduced extracellular dopamine and increased responsiveness to novelty: neurochemical and behavioral sequelae of intermittent hypoxia. Sleep. 2005 Feb;28(2):169-76. doi: 10.1093/sleep/28.2.169.
Background: PubMed 28828549Decker MJ, Jones KA, Keating GL, Rye DB. Postnatal hypoxia evokes persistent changes within the male rat's dopaminergic system. Sleep Breath. 2018 May;22(2):547-554. doi: 10.1007/s11325-017-1558-6. Epub 2017 Aug 22.
Background: PubMed 27047695Rocha-Ferreira E, Hristova M. Plasticity in the Neonatal Brain following Hypoxic-Ischaemic Injury. Neural Plast. 2016;2016:4901014. doi: 10.1155/2016/4901014. Epub 2016 Mar 7.
Background: PubMed 8817697Nyakas C, Buwalda B, Luiten PG. Hypoxia and brain development. Prog Neurobiol. 1996 May;49(1):1-51. doi: 10.1016/0301-0082(96)00007-x.
Individual participant dataSharing planned: Undecided. Because this is a vulnerable population and a small sample size from a known cohort of children, it is unclear of the institutional requirements for sharing individual participant data in any format other than peer-reviewed publications. The investigators will make datasets from this study available upon completion of the study. Those who are interested will submit a brief research plan to the Principal Investigators. Qualified investigators whose research question can be appropriately addressed by the requested dataset will be invited to discuss their plan and finalize details with the investigators via phone or in person.

Related trials for Perinatal Hypoxia

Recruiting
Neuro-MoD: Neuroplasticity With Motor Development
Perinatal Brain Injury
Recruiting
The HIEnome Study: Genome Sequencing for Perinatal HIE
Hypoxic Ischemic Encephalopathy of Newborn, Hypoxic Ischemic Encephalopathy
Not yet recruitingPhase 2/3
Intranasal Stem Cells to Treat Perinatal Brain Injury to Combat Cerebral Palsy
Perinatal Arterial Ischemic Stroke, Perinatal Asphyxia
RecruitingObservational study
Baby Brain Recovery Study
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Not yet recruitingPhase 1/2
Mesenchymal Stem Cells With Cooling Therapy for Infants With Hypoxic-Ischemic Encephalopathy
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael J Decker, PhD principal investigator

Case Western Reserve University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Perinatal Hypoxia and Dopamine, run by Case Western Reserve University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Structural Integrity of Dopaminergic Circuits (time frame: 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03407729, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022.