S100B as a Marker of Brain Injury of Preterm Infants (PTS100B)
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|ClinicalTrials.gov Identifier: NCT02082535|
Recruitment Status : Unknown
Verified March 2014 by Dr. Omer Bar-Yosef, Sheba Medical Center.
Recruitment status was: Recruiting
First Posted : March 10, 2014
Last Update Posted : March 11, 2014
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.
|Condition or disease|
|Premature Birth Brain Injuries Leukomalacia Periventricular Developmental Disabilities|
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||S100B as a Marker of Brain Injury of Preterm Infants|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||February 2017|
- 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
- Developmental assessment at 18 month [ Time Frame: 21 month after recruitment ]Neurological examination Griffith mental developmental scales (GMD-2) Vineland adaptive behavioral scale (VinelandTM-II) Clinical Adaptive Test/Clinical Linguistic and Auditory Milestone Scale
- Developmental assessment at 3 month corrected age [ Time Frame: 5-6 months after recuitment ]Neurological examination General Movements assessment Griffith mental developmental scales (GMD-2) Clinical Adaptive Test/Clinical Linguistic and Auditory Milestone Scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082535
|Contact: Omer Bar Yosef, M.D. Ph.D.||firstname.lastname@example.org|
|Contact: Leah Leibovitch, M.D.||972-52-6667325||Leah.Leibovitch@sheba.health.gov.il|
|Sheba medical center||Recruiting|
|Ramat Gan, Israel, 52621|
|Contact: Omer Bar-Yosef, Dr. 972-52-6667344 email@example.com|
|Principal Investigator: Omer Bar-Yosef, M.D. PH.D.|
|Sub-Investigator: Leah Leibovitch, M.D.|
|Sub-Investigator: Tzipi Strauss, M.D.|
|Sub-Investigator: Iris Morag, M.D.|
|Principal Investigator:||Omer Bar Yosef, M.D. Ph.D.||Sheba Medical Center, Ramat Gan, Israel|