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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Sheba Medical Center
Information provided by (Responsible Party):
Dr. Omer Bar-Yosef, Sheba Medical Center
ClinicalTrials.gov Identifier:
First received: February 11, 2014
Last updated: March 8, 2014
Last verified: March 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.

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 Sheba Medical Center:

Primary Outcome Measures:
  • MRI at term age [ Time Frame: 2-3 month after recruitment ] [ Designated as safety issue: No ]
    MRI description according to the protocol suggested by woodward et. al. (2006)

  • S100b and GFAP [ Time Frame: 2-3 months after recruitment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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)

Ages Eligible for Study:   up to 2 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Very early preterm infants born before 30 weeks gestational age

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02082535

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

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
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 
Study First Received: February 11, 2014
Last Updated: March 8, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by 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
Brain Injuries
Developmental Disabilities
Premature Birth
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Craniocerebral Trauma
Infant, Newborn, Diseases
Infant, Premature, Diseases
Mental Disorders
Nervous System Diseases
Neurodevelopmental Disorders
Obstetric Labor Complications
Obstetric Labor, Premature
Pregnancy Complications
Trauma, Nervous System
Vascular Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2016