Human DevelopmentNCT02170142
Characterization of the Functional and Structural Development of the Human Neonatal Brain From 30 Wks to 45 Wks ga
An observational study of Human Development, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The major goal of this project is to characterize the structural and functional development of cortical plate and white matter of the human neonatal brain from the equivalent 30 gestational weeks to 45 gestational weeks. The project is sponsored by niH R01MH092535. Read more about this study
- Who is it for?
- Ages 30 to 45 weeksHealthy volunteers can take part
- Conditions the study is for
- Human Development
- What is being tested?
- MRI
- Type of treatment
- Medical device
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 30 to 45 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Neonates in the neonatal intensive care unit at Parkland Hospital
Who may be able to join
- Normal infants of both genders
- Any race or ethnicity
- Inborn preterm delivered from 30-45 weeks gestation
- Medically stable for transport i.e. requiring at most a nasal canula < 2 liters for respiratory support.
Who cannot join
- Infants not delivered from 30-45 weeks gestation
- Infants who may have a neurological event at birth
- Presence of known or suspected congenital anomalies such as chromosomal anomalies
- Major congenital heart disease or congenital infection
- Substance abuse and any grade>1 of intraventricular hemorrhage (IVH) by cranial ultrasound
- Presence of cystic periventricular leukomalacia (PVL) by cranial ultrasound
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Major Goal of This Project is to Characterize the Structural and Functional Development of Cortical Plate and White Matter of the Human Neonatal Brain From the Equivalent 30 Gestational Weeks to 45 Gestational Weeks.
The major goal of this project is to characterize the structural and functional development of cortical plate and white matter of the human neonatal brain from the equivalent 30 gestational weeks to 45 gestational weeks. The project is sponsored by niH R01MH092535. Furthermore, it is related to the blue print project of transcriptome atlas (niH RC2MH089921) with at least 36 million funding also sponsored by niH.
Revealing detailed anatomy at different equivalent gestational ages of human neonatal brain not only aids in understanding this highly ordered process, but also provides clues to detect abnormalities caused by genetic or environmental factors. Cerebral vascular measurements offer important information on cerebral metabolism. However, either anatomical or functional studies of human brain development during this period are surprisingly scarce. Diffusion tensor imaging (DTi), a recently developed technology of magnetic resonance imaging (MRi), is capable of noninvasively delineating macroscopic anatomical components with high contrast and revealing structures at the microscopic level. Cerebral vascular quantification including cerebral blood flow (CBF) and cerebral metabolic rate of oxygen (CMRo2) can also be obtained through noninvasive MRi, specifically arterial spin labeling (aSL) and T2-relaxation under spin tagging (TRuST) MRi. in this proposed study, the structure and function of neonatal brain will be explored using noninvasive MRi technologies. 102 infants will be recruited and no sedation will be applied during MRi. The resultant database will provide reference standards for diagnostic radiology of premature newborns and reveal the vascular activities of these newborn brains. Specifically, three aims will be achieved:
- To delineate the anatomical development of complex structure in the cerebral wall and white matter tracts of neonatal brains at different equivalent gestational ages.
- To quantify the cerebral blood flow and metabolic rate of oxygen of neonatal brain.
- To correlate the structural and functional measurements with the gene transcriptome results.
Read the detailed description
102 normal infants with age of 30 gestational weeks to 45 gestational weeks will be recruited in partnership with Division of Perinatal-neonatal Medicine which consists of neonatologists and pediatricians providing services in Parkland Health and Hospital System (PHHS) and Children's Medical Center (CMC) at Dallas. among 102 normal infants, there are 17 subjects at each following subgroup, 30-31 gestational weeks, 32-33 gestational weeks, 34-35 gestational weeks, 36-38 gestational weeks, 39-42 gestational week and 43-45 gestational weeks. once these infants are identified, structural and functional MRi data will be acquired with Philips 3T located at Radiology of CMC. The sequence details are as follows: DTi: a single-shot echo-planar imaging (ePi) sequence with SenSe parallel imaging scheme (SenSitivity encoding, reduction factor [?]2.5) will be used. The imaging matrix will be 112x112 with a field of view of 168x168mm (nominal resolution of 1.5mm), which will be zero filled to 256x256. axial slices of 1.5mm thickness will be acquired parallel to the anterior-posterior commissure line (aC-PC). a total of 65 slices will cover the entire hemisphere and brainstem without gap. The diffusion weighting will be encoded along 30 independent orientations and b value will be 1000s/mm2. imaging time for each sequence will be 5 minutes and 30 seconds. To increase signal noise ratio (SnR), two repetitions will be performed, resulting in DTi imaging time 11 minutes.
T1/T2-weighted imaging: Co-registered T2 weighted image, using a spin echo sequence, will be acquired with the echo time 120ms. Repetition time (TR) will be 4,500ms. The imaging resolution will be same as that of DTi. Co-registered FLaiR (Fluid attenuated inversion Recovery) T1 weighted image will also be acquired with the same field of view as that in diffusion tensor imaging. The T1/T2 weighted imaging time will be 5 minutes.
Resting state fMRi: Time series of 240 volumes of BoLD (Blood-oxygenation-Level-Dependent) images will be acquired with a single-shot gradient-recalled T2* weighted ePi pulse sequence. The details of the sequence are as follows: TR [?] 1500 ms; flip angle [?] 90o; slice thickness[?]2.5mm; matrix [?] 68 x 68; FoV [?] 168 mm x 168 mm; voxel size[?]2.5x2.5x2.5mm.
aSL and TRuST: Pseudo-Continuous aSL (PCaSL) sequence combined with a phase-contrast sequence will be used to obtain voxel level CBF estimation in units of ml blood per 100 g of tissue per min (ml/100g/min). The PCaSL sequence will be: field of view [?] 168x168mm, matrix[?]84x84, slice thickness[?]2mm, 50 axial slices acquired with zero gap, voxel size[?]2x2x2mm, SenSe factor[?]2.5. The phase contrast MRi will be performed with the slice location perpendicular to the four major feeding arteries (left/right internal carotid and vertebral arteries) at the level of cervical spine 3 (C3). Baseline venous oxygenation (Yv) will be determined in the sagittal sinus using a recently developed T2-Relaxation-under-Spin-Tagging (TRuST) MRi technique. The imaging parameters will be: voxel size 3.44x3.44x5mm3, four different T2-weightings with Tes of 0ms, 40ms, 80ms and 160ms, duration 1 minutes and 12 seconds. The imaging slice will be positioned axially to intersect the superior sagittal sinus at the level of approximately 10mm above the sinus congruence.
Single voxel MRS: Single voxel proton MRS with short Te will be acquired. PReSS (Point ReSolved Spectroscopy) will be used.
- Conditions
- Human Development
- Being tested
- MRI
- Keywords
- MRI, perinatal brain, development, neonates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
Also called 3T Philips Achieva MRI
non-invasive MRI techniques (DTI) and (ASL) will be used to assess normal brain development. DTI is capable of invasively delineating macroscopic anatomic components with high contrast and revealing structures at the microscopic level. ASL is capable of measuring cerebral blood flow and cerebral metabolic rate of oxygen.
| Study group | Role | What they receive |
|---|---|---|
| No treatment | All subjects studied are normal healthy neonates without a condition. MRI will be used to assess normal brain development. Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
To observe normal brain development in neonates using MR imaging.
Measured: neonates from 30 wg to 45 wg
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startFeb 2012
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human DevelopmentStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Hao Huang, PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02170142
- Sponsor's protocol ID
- NCT02170142
- Other IDs
- R01MH092535
- Status last verified
- Sep 2019
- First submitted
- 13 Jun 2014
- Last updated
- 9 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Huang H, Jeon T, Sedmak G, Pletikos M, Vasung L, Xu X, Yarowsky P, Richards LJ, Kostovic I, Sestan N, Mori S. Coupling diffusion imaging with histological and gene expression analysis to examine the dynamics of cortical areas across the fetal period of human brain development. Cereb Cortex. 2013 Nov;23(11):2620-31. doi: 10.1093/cercor/bhs241. Epub 2012 Aug 28.
PubMed 22933464
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Major Goal of This Project is to Characterize the Structural and Functional Development of Cortical Plate and White Matter of the Human Neonatal Brain From the Equivalent 30 Gestational Weeks to 45 Gestational Weeks.
- ClinicalTrials.gov ID
- NCT02170142
- Acronym / sponsor ID
- NCT02170142
- Conditions
- Human Development
- Keywords
- MRI, perinatal brain, development, neonates
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Feb 2012 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 23 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The major goal of this project is to characterize the structural and functional development of cortical plate and white matter of the human neonatal brain from the equivalent 30 gestational weeks to 45 gestational weeks. The project is sponsored by niH R01MH092535. Furthermore, it is related to the blue print project of transcriptome atlas (niH RC2MH089921) with at least 36 million funding also sponsored by niH.
Revealing detailed anatomy at different equivalent gestational ages of human neonatal brain not only aids in understanding this highly ordered process, but also provides clues to detect abnormalities caused by genetic or environmental factors. Cerebral vascular measurements offer important information on cerebral metabolism. However, either anatomical or functional studies of human brain development during this period are surprisingly scarce. Diffusion tensor imaging (DTi), a recently developed technology of magnetic resonance imaging (MRi), is capable of noninvasively delineating macroscopic anatomical components with high contrast and revealing structures at the microscopic level. Cerebral vascular quantification including cerebral blood flow (CBF) and cerebral metabolic rate of oxygen (CMRo2) can also be obtained through noninvasive MRi, specifically arterial spin labeling (aSL) and T2-relaxation under spin tagging (TRuST) MRi. in this proposed study, the structure and function of neonatal brain will be explored using noninvasive MRi technologies. 102 infants will be recruited and no sedation will be applied during MRi. The resultant database will provide reference standards for diagnostic radiology of premature newborns and reveal the vascular activities of these newborn brains. Specifically, three aims will be achieved:
- To delineate the anatomical development of complex structure in the cerebral wall and white matter tracts of neonatal brains at different equivalent gestational ages.
- To quantify the cerebral blood flow and metabolic rate of oxygen of neonatal brain.
- To correlate the structural and functional measurements with the gene transcriptome results.
Detailed description
102 normal infants with age of 30 gestational weeks to 45 gestational weeks will be recruited in partnership with Division of Perinatal-neonatal Medicine which consists of neonatologists and pediatricians providing services in Parkland Health and Hospital System (PHHS) and Children's Medical Center (CMC) at Dallas. among 102 normal infants, there are 17 subjects at each following subgroup, 30-31 gestational weeks, 32-33 gestational weeks, 34-35 gestational weeks, 36-38 gestational weeks, 39-42 gestational week and 43-45 gestational weeks. once these infants are identified, structural and functional MRi data will be acquired with Philips 3T located at Radiology of CMC. The sequence details are as follows: DTi: a single-shot echo-planar imaging (ePi) sequence with SenSe parallel imaging scheme (SenSitivity encoding, reduction factor [?]2.5) will be used. The imaging matrix will be 112x112 with a field of view of 168x168mm (nominal resolution of 1.5mm), which will be zero filled to 256x256. axial slices of 1.5mm thickness will be acquired parallel to the anterior-posterior commissure line (aC-PC). a total of 65 slices will cover the entire hemisphere and brainstem without gap. The diffusion weighting will be encoded along 30 independent orientations and b value will be 1000s/mm2. imaging time for each sequence will be 5 minutes and 30 seconds. To increase signal noise ratio (SnR), two repetitions will be performed, resulting in DTi imaging time 11 minutes.
T1/T2-weighted imaging: Co-registered T2 weighted image, using a spin echo sequence, will be acquired with the echo time 120ms. Repetition time (TR) will be 4,500ms. The imaging resolution will be same as that of DTi. Co-registered FLaiR (Fluid attenuated inversion Recovery) T1 weighted image will also be acquired with the same field of view as that in diffusion tensor imaging. The T1/T2 weighted imaging time will be 5 minutes.
Resting state fMRi: Time series of 240 volumes of BoLD (Blood-oxygenation-Level-Dependent) images will be acquired with a single-shot gradient-recalled T2* weighted ePi pulse sequence. The details of the sequence are as follows: TR [?] 1500 ms; flip angle [?] 90o; slice thickness[?]2.5mm; matrix [?] 68 x 68; FoV [?] 168 mm x 168 mm; voxel size[?]2.5x2.5x2.5mm.
aSL and TRuST: Pseudo-Continuous aSL (PCaSL) sequence combined with a phase-contrast sequence will be used to obtain voxel level CBF estimation in units of ml blood per 100 g of tissue per min (ml/100g/min). The PCaSL sequence will be: field of view [?] 168x168mm, matrix[?]84x84, slice thickness[?]2mm, 50 axial slices acquired with zero gap, voxel size[?]2x2x2mm, SenSe factor[?]2.5. The phase contrast MRi will be performed with the slice location perpendicular to the four major feeding arteries (left/right internal carotid and vertebral arteries) at the level of cervical spine 3 (C3). Baseline venous oxygenation (Yv) will be determined in the sagittal sinus using a recently developed T2-Relaxation-under-Spin-Tagging (TRuST) MRi technique. The imaging parameters will be: voxel size 3.44x3.44x5mm3, four different T2-weightings with Tes of 0ms, 40ms, 80ms and 160ms, duration 1 minutes and 12 seconds. The imaging slice will be positioned axially to intersect the superior sagittal sinus at the level of approximately 10mm above the sinus congruence.
Single voxel MRS: Single voxel proton MRS with short Te will be acquired. PReSS (Point ReSolved Spectroscopy) will be used.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | – | Device: MRIAll subjects studied are normal healthy neonates without a condition. MRI will be used to assess normal brain development. |
Who may qualify
- Ages
- 30 to 45 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Neonates in the neonatal intensive care unit at Parkland Hospital
Key inclusion criteria (4 listed)
- Normal infants of both genders
- Any race or ethnicity
- Inborn preterm delivered from 30-45 weeks gestation
- Medically stable for transport i.e. requiring at most a nasal canula < 2 liters for respiratory support.
Key exclusion criteria (6 listed)
- Infants not delivered from 30-45 weeks gestation
- Infants who may have a neurological event at birth
- Presence of known or suspected congenital anomalies such as chromosomal anomalies
- Major congenital heart disease or congenital infection
- Substance abuse and any grade>1 of intraventricular hemorrhage (IVH) by cranial ultrasound
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 |
|---|---|---|
| MRIAlso: 3T Philips Achieva MRInon-invasive MRI techniques (DTI) and (ASL) will be used to assess normal brain development. DTI is capable of invasively delineating macroscopic anatomic components with high contrast and revealing structures at the microscopic level. ASL is capable of measuring cerebral blood flow and cerebral metabolic rate of oxygen. | Device | No treatment |
Primary outcome
To observe normal brain development in neonates using MR imaging.
Time frame: neonates from 30 wg to 45 wg
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Background: PubMed 22933464Huang H, Jeon T, Sedmak G, Pletikos M, Vasung L, Xu X, Yarowsky P, Richards LJ, Kostovic I, Sestan N, Mori S. Coupling diffusion imaging with histological and gene expression analysis to examine the dynamics of cortical areas across the fetal period of human brain development. Cereb Cortex. 2013 Nov;23(11):2620-31. doi: 10.1093/cercor/bhs241. Epub 2012 Aug 28.
- The BrainSpan atlas is a foundational resource for studying transcriptional mechanisms involved in human brain development.Link provided by the sponsor.
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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.
Hao Huang, PhD principal investigator
University of Texas Southwestern Medical Center
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 Human Development, run by University of Texas Southwestern Medical Center 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 4 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 9 Sep 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To observe normal brain development in neonates using MR imaging. (time frame: neonates from 30 wg to 45 wg). 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 NCT02170142, which also lists 1 linked publication.
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 9 Sep 2019.