Premature BirthPTS100BNCT02082535
S100B as a Marker of Brain Injury of Preterm Infants
An observational study of Premature Birth and Brain Injuries, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The improvement of treatment of preterm neonates improved their survival, however there is still significant portion of preterm infants (specifically very preterm infants) that suffers from brain insults and as a result developmental deficits. Read more about this study
- Who is it for?
- Ages 1 day to 2 days
- Conditions the study is for
- Premature Birth, Brain Injuries, Leukomalacia Periventricular
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2014to Feb 2017
- 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 1 day to 2 days
- All sexes
- No healthy volunteers
- Child
Study population: Very early preterm infants born before 30 weeks gestational age
Who may be able to join
- Preterm delivery before 30 week gestational age
Who cannot join
- Dysmorphic features in initial neurological examination
- Antenatal brain injury on fetal MRI or ultrasound
- Brain malformation
- Maternal drug abuse
- Maternal use of teratogenic medications
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba medical center
Ramat Gan, 52621
Omer Bar-Yosef, Dr., 972-52-6667344, omerbary@gmail.com
Omer Bar-Yosef, M.D. PH.D.
About this study
The improvement of treatment of preterm neonates improved their survival, however there is still significant portion of preterm infants (specifically very preterm infants) that suffers from brain insults and as a result developmental deficits. The brain injury is a consequence of hypoxic ischemic events, intracranial hemorrhages, as well as, infections and metabolic crisis. The brain injury is a combination of abnormal myelination, axonal damage and neuronal death. Although there is reduction in focal brain injury, diffuse brain injury is still abundant. Several treatments has been suggested and tested in animal models to prevent the brain insults including glutamate receptor blockers, allopurinol, xenon and different types of stem cells. However, two main obstacles prevent the use of these medication, first the uncertainty of their effect on the developing brain and second the difficulty to time the brain insult. Unlike neonatal asphyxia, when the delivery time and clinical signs are used to time and grade the brain injury, in preterm infants there is no real time tool to indicate severity and timing of brain injury. The disability point out a beneficial therapeutic window is a major obstacle in the acute treatment of brain injury in preterm infants. The aim of this study is to try and delineate such therapeutic window by using brain injury biomarkers.
S100b and GFAP are well recognized biomarkers of brain injury in adults, children and infants. Serial measurements of S100b in saliva (every 2 days) and GFAP in serum (weekly) will be sampled. A database of the clinical status of the infants will be collected, as well as, head ultra sound weekly and head MRI a term age. Development will be assessed by at 18 months. Two hypotheses are stated: One, increase in the levels of S100b and GFAP in their timing will be correlated with the severity of the clinical status, Two the duration of increased level of S100b and GFAP will be associated with abnormal MRI at term findings and abnormal developmental assessment.
- Keywords
- Premature Birth, Brain Injuries, Leukomalacia Periventricular, S100B protein human, Glial Fibrillary Acidic Protein, Magnetic Resonance Imaging, Developmental Disabilities
- Medical subject headings
- Premature Birth, Brain Injuries, Leukomalacia, Periventricular, Developmental Disabilities
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI at term age
MRI description according to the protocol suggested by woodward et. al. (2006)
Measured: 2-3 month after recruitment
S100b and GFAP
The level of S100b in a sample of 0.5 cc saliva will collected every 2 days and GFAP every week from the day of birth to discharge
Measured: 2-3 months after recruitment
Secondary outcomes (2)
Developmental assessment at 18 month
Neurological examination Griffith mental developmental scales (GMD-2) Vineland adaptive behavioral scale (VinelandTM-II) Clinical Adaptive Test/Clinical Linguistic and Auditory Milestone Scale
Measured: 21 month after recruitment
Developmental assessment at 3 month corrected age
Neurological examination General Movements assessment Griffith mental developmental scales (GMD-2) Clinical Adaptive Test/Clinical Linguistic and Auditory Milestone Scale
Measured: 5-6 months after recuitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by Sheba 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Omer Bar-Yosef, Sheba Medical Center
- Investigators
- Omer Bar Yosef, M.D. Ph.D., Principal investigator, Sheba Medical Center, Ramat Gan, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02082535
- Sponsor's protocol ID
- SHEBA-13-0044-0B-CTIL
- Acronym
- PTS100B
- Status last verified
- Mar 2014
- First submitted
- 11 Feb 2014
- Last updated
- 11 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- S100B as a Marker of Brain Injury of Preterm Infants
- ClinicalTrials.gov ID
- NCT02082535
- Acronym / sponsor ID
- PTS100B / SHEBA-13-0044-0B-CTIL
- Keywords
- Premature Birth, Brain Injuries, Leukomalacia Periventricular, S100B protein human, Glial Fibrillary Acidic Protein, Magnetic Resonance Imaging, Developmental Disabilities
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Feb 2014
- Primary completion
- Feb 2017 (estimated)
- First posted
- 10 Mar 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 improvement of treatment of preterm neonates improved their survival, however there is still significant portion of preterm infants (specifically very preterm infants) that suffers from brain insults and as a result developmental deficits. The brain injury is a consequence of hypoxic ischemic events, intracranial hemorrhages, as well as, infections and metabolic crisis. The brain injury is a combination of abnormal myelination, axonal damage and neuronal death. Although there is reduction in focal brain injury, diffuse brain injury is still abundant. Several treatments has been suggested and tested in animal models to prevent the brain insults including glutamate receptor blockers, allopurinol, xenon and different types of stem cells. However, two main obstacles prevent the use of these medication, first the uncertainty of their effect on the developing brain and second the difficulty to time the brain insult. Unlike neonatal asphyxia, when the delivery time and clinical signs are used to time and grade the brain injury, in preterm infants there is no real time tool to indicate severity and timing of brain injury. The disability point out a beneficial therapeutic window is a major obstacle in the acute treatment of brain injury in preterm infants. The aim of this study is to try and delineate such therapeutic window by using brain injury biomarkers.
S100b and GFAP are well recognized biomarkers of brain injury in adults, children and infants. Serial measurements of S100b in saliva (every 2 days) and GFAP in serum (weekly) will be sampled. A database of the clinical status of the infants will be collected, as well as, head ultra sound weekly and head MRI a term age. Development will be assessed by at 18 months. Two hypotheses are stated: One, increase in the levels of S100b and GFAP in their timing will be correlated with the severity of the clinical status, Two the duration of increased level of S100b and GFAP will be associated with abnormal MRI at term findings and abnormal developmental assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 2 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Very early preterm infants born before 30 weeks gestational age
Key inclusion criteria (1 listed)
- Preterm delivery before 30 week gestational age
Key exclusion criteria (5 listed)
- Dysmorphic features in initial neurological examination
- Antenatal brain injury on fetal MRI or ultrasound
- Brain malformation
- Maternal drug abuse
- Maternal use of teratogenic medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MRI at term age
Time frame: 2-3 month after recruitment
MRI description according to the protocol suggested by woodward et. al. (2006)
S100b and GFAP
Time frame: 2-3 months after recruitment
The level of S100b in a sample of 0.5 cc saliva will collected every 2 days and GFAP every week from the day of birth to discharge
2 secondary outcomes
Developmental assessment at 18 month
Time frame: 21 month after recruitment
Developmental assessment at 3 month corrected age
Time frame: 5-6 months after recuitment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2014.
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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.
Omer Bar Yosef, M.D. Ph.D. principal investigator
Sheba Medical Center, Ramat Gan, Israel
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 Premature Birth and Brain Injuries, run by Sheba Medical Center at 1 site in Israel.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 11 Mar 2014. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omer Bar Yosef, M.D. Ph.D. (972-526667344, omer.baryosef@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI at term age (time frame: 2-3 month after recruitment). 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?
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 11 Mar 2014.