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S100B as a Marker of Brain Injury of Preterm Infants (PTS100B)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2014 by Dr. Omer Bar-Yosef, Sheba Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02082535
First Posted: March 10, 2014
Last Update Posted: March 11, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Omer Bar-Yosef, Sheba Medical Center
  Purpose

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
Premature Birth Brain Injuries Leukomalacia Periventricular Developmental Disabilities

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: S100B as a Marker of Brain Injury of Preterm Infants

Resource links provided by NLM:


Further study details as provided by Dr. Omer Bar-Yosef, Sheba Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 40
Study Start Date: February 2014
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Very early preterm infants born before 30 weeks gestational age
Criteria

Inclusion Criteria:

- Preterm delivery before 30 week gestational age

Exclusion Criteria:

  • Dysmorphic features in initial neurological examination
  • Antenatal brain injury on fetal MRI or ultrasound
  • Brain malformation
  • Maternal drug abuse
  • Maternal use of teratogenic medications
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Omer Bar Yosef, M.D. Ph.D. 972-526667344 omer.baryosef@sheba.health.gov.il
Contact: Leah Leibovitch, M.D. 972-52-6667325 Leah.Leibovitch@sheba.health.gov.il

Locations
Israel
Sheba medical center Recruiting
Ramat Gan, Israel, 52621
Contact: Omer Bar-Yosef, Dr.    972-52-6667344    omerbary@gmail.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.         
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Omer Bar Yosef, M.D. Ph.D. Sheba Medical Center, Ramat Gan, Israel
  More Information

Responsible Party: Dr. Omer Bar-Yosef, Physician, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02082535     History of Changes
Other Study ID Numbers: SHEBA-13-0044-0B-CTIL
First Submitted: February 11, 2014
First Posted: March 10, 2014
Last Update Posted: March 11, 2014
Last Verified: March 2014

Keywords provided by Dr. Omer Bar-Yosef, Sheba Medical Center:
Premature Birth
Brain Injuries
Leukomalacia Periventricular
S100B protein human
Glial Fibrillary Acidic Protein
Magnetic Resonance Imaging
Developmental Disabilities

Additional relevant MeSH terms:
Leukomalacia, Periventricular
Wounds and Injuries
Brain Injuries
Premature Birth
Developmental Disabilities
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Neurodevelopmental Disorders
Mental Disorders
Cerebrovascular Disorders
Encephalomalacia
Vascular Diseases
Cardiovascular Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases