Brain Injury, Fetus and NeonateNCT00131859
Diffusion-Tensor Magnetic Resonance Imaging (MRI) and the Evaluation of Perinatal Brain Injury
An observational study of Brain Injury, Fetus and Neonate, run by Johns Hopkins University at 2 sites in United States.
Trial summary
The researchers' objective is to use diffusion-tensor imaging (DTI) to evaluate infants diagnosed with cerebral white matter injury during the neonatal period and identify antenatal risk factors, electronic fetal heart rate monitoring abnormalities, and umbilical arterial gas results that are associated with cerebral… Read more about this study
- Who is it for?
- Ages 23 weeks to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Brain Injury, Fetus and Neonate
- What is being tested?
- Diffusion-tensor imaging
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2004to Dec 2008
- 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 23 weeks to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Neonates < 1500 grams, with suspected brain injury, and with severe metabolic acidosis
Who may be able to join
- All infants born at our hospital at < 1500 grams
- All infants born at our hospital at > 1500 grams with brain injury or severe metabolic acidosis
Who cannot join
- Major congenital malformations
- Chromosomal abnormality
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287-1228
Johns Hopkins Hospital
Baltimore, Maryland, 21287
About this study
Official title: Diffusion-Tensor Magnetic Resonance Imaging and the Evaluation of Perinatal Brain Injury
The researchers' objective is to use diffusion-tensor imaging (DTI) to evaluate infants diagnosed with cerebral white matter injury during the neonatal period and identify antenatal risk factors, electronic fetal heart rate monitoring abnormalities, and umbilical arterial gas results that are associated with cerebral white matter injury. The researchers' hypothesis is that this new imaging technique will help us better understand how these devastating injuries occur.
Read the detailed description
Maternal and neonatal data will be collected as well as the umbilical arterial gas results and the electronic fetal heart rate tracing of the labor. Infants will have a head ultrasound at 24-72 hours, 10-14 days, and at 4-6 weeks to look for cerebral white matter injury, as standard of care. All infants with a birth weight < 1500 grams will be offered DTI, and infants > 1500 grams with white matter injury diagnosed by ultrasound will be imaged as well as the subsequent delivery born within 7 days of that gestational age without brain injury. All infants will have the DTI brain scan at 12-18 months of age corrected for the degree of prematurity, and will also have a formal neurological assessment at that time.
- Conditions
- Brain Injury, Fetus and Neonate
- Being tested
- Diffusion-tensor imaging
- Keywords
- Perinatal brain injury, Diffusion-tensor imaging
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffusion-tensor imagingProcedure or surgery
Also called No other names applicable.
Obtain a Diffusion tensor MRI of brain.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diffusion-tensor imaging differences between brain injured cases and controls without brain injury
Measured: 2 years
Secondary outcomes (4)
Umbilical cord gas results
Measured: 2 years
Placental pathology
Measured: 2 years
Electronic fetal monitoring
Measured: 2 years
Nucleated red blood cells
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2005 (estimated)
- Study startOct 2004
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injury, Fetus and NeonateStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Investigators
- Ernest M Graham, M.D., Principal investigator, Johns Hopkins Univ; Dept. of Gyn-Ob
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00131859
- Sponsor's protocol ID
- 04-08-31-01
- Status last verified
- Aug 2009
- First submitted
- 18 Aug 2005
- Last updated
- 13 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffusion-Tensor Magnetic Resonance Imaging and the Evaluation of Perinatal Brain Injury
- ClinicalTrials.gov ID
- NCT00131859
- Acronym / sponsor ID
- 04-08-31-01
- Conditions
- Brain Injury, Fetus and Neonate
- Keywords
- Perinatal brain injury, Diffusion-tensor imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Study start
- Oct 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 19 Aug 2005 (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 researchers' objective is to use diffusion-tensor imaging (DTI) to evaluate infants diagnosed with cerebral white matter injury during the neonatal period and identify antenatal risk factors, electronic fetal heart rate monitoring abnormalities, and umbilical arterial gas results that are associated with cerebral white matter injury. The researchers' hypothesis is that this new imaging technique will help us better understand how these devastating injuries occur.
Detailed description
Maternal and neonatal data will be collected as well as the umbilical arterial gas results and the electronic fetal heart rate tracing of the labor. Infants will have a head ultrasound at 24-72 hours, 10-14 days, and at 4-6 weeks to look for cerebral white matter injury, as standard of care. All infants with a birth weight < 1500 grams will be offered DTI, and infants > 1500 grams with white matter injury diagnosed by ultrasound will be imaged as well as the subsequent delivery born within 7 days of that gestational age without brain injury. All infants will have the DTI brain scan at 12-18 months of age corrected for the degree of prematurity, and will also have a formal neurological assessment at that time.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 23 weeks to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Neonates < 1500 grams, with suspected brain injury, and with severe metabolic acidosis
Key inclusion criteria (2 listed)
- All infants born at our hospital at < 1500 grams
- All infants born at our hospital at > 1500 grams with brain injury or severe metabolic acidosis
Key exclusion criteria (2 listed)
- Major congenital malformations
- Chromosomal abnormality
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 |
|---|---|---|
| Diffusion-tensor imagingAlso: No other names applicable.Obtain a Diffusion tensor MRI of brain. | Procedure or surgery | – |
Primary outcome
Diffusion-tensor imaging differences between brain injured cases and controls without brain injury
Time frame: 2 years
4 secondary outcomes
Umbilical cord gas results
Time frame: 2 years
Placental pathology
Time frame: 2 years
Electronic fetal monitoring
Time frame: 2 years
Nucleated red blood cells
Time frame: 2 years
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 13 Aug 2009.
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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.
Ernest M Graham, M.D. principal investigator
Johns Hopkins Univ; Dept. of Gyn-Ob
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injury, Fetus and Neonate, run by Johns Hopkins University at 2 sites 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 2 inclusion and 2 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 13 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Diffusion-tensor imaging differences between brain injured cases and controls without brain injury (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2009.