S100B as a Marker of Brain Injury of Preterm Infants

NCT02082535 | Unknown

• 1 other identifier: SHEBA-13-0044-0B-CTIL
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Premature Birth; Brain Injuries; Leukomalacia Periventricular; S100B protein human; Glial Fibrillary Acidic Protein; Magnetic Resonance Imaging; Developmental Disabilities

Outcome Measures

Primary Outcomes (2)

• MRI at term age

  MRI description according to the protocol suggested by woodward et. al. (2006)

  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

  2-3 months after recruitment

Secondary Outcomes (2)

• Developmental assessment at 18 month

  21 month after recruitment

• Developmental assessment at 3 month corrected age

  5-6 months after recuitment

Eligibility Criteria

• Age: 1 Day - 2 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Very early preterm infants born before 30 weeks gestational age

You may qualify if:

• \- Preterm delivery before 30 week gestational age

You may not qualify if:

• Dysmorphic features in initial neurological examination
• Antenatal brain injury on fetal MRI or ultrasound
• Brain malformation
• Maternal drug abuse
• Maternal use of teratogenic medications

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba medical center

Ramat Gan, 52621, Israel

RECRUITING

MeSH Terms

Conditions

Premature Birth; Brain Injuries; Leukomalacia, Periventricular; Developmental Disabilities

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Encephalomalacia; Vascular Diseases; Cardiovascular Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Omer Bar Yosef, M.D. Ph.D.

  Sheba Medical Center, Ramat Gan, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

972-526667344; omer.baryosef@sheba.health.gov.il

Leah Leibovitch, M.D.

CONTACT

972-52-6667325; Leah.Leibovitch@sheba.health.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: February 11, 2014
• First Posted: March 10, 2014
• Study Start: February 1, 2014
• Primary Completion: February 1, 2017
• Last Updated: March 11, 2014

Record last verified: 2014-03

Locations

IL (1)