S100B as a Marker of Brain Injury of Preterm Infants

NCT ID: NCT02082535

Last Updated: 2014-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-02-28

Brief 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. 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.

Conditions

Premature Birth; Brain Injuries; Leukomalacia Periventricular; Developmental Disabilities

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 2 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Omer Bar-Yosef

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Omer Bar Yosef, M.D. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center, Ramat Gan, Israel

Locations

Sheba medical center

Ramat Gan, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Omer Bar Yosef, M.D. Ph.D.

Role: CONTACT

omer.baryosef@sheba.health.gov.il

972-526667344

Leah Leibovitch, M.D.

Role: CONTACT

Leah.Leibovitch@sheba.health.gov.il

972-52-6667325

Facility Contacts

Omer Bar-Yosef, Dr.

Role: primary

omerbary@gmail.com

972-52-6667344

Other Identifiers

SHEBA-13-0044-0B-CTIL

Identifier Type: -

Identifier Source: org_study_id