Clinical Trial: S100B as a Marker of Brain Injury of Preterm Infants

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Observational

Official Title: S100B as a Marker of Brain Injury of Preterm Infants

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 du

Detailed Summary:
Sponsor: Sheba Medical Center

Current Primary Outcome:

• 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

Original Primary Outcome:

• MRI at term age [ Time Frame: 2-3 month after recruitment ]
  MRI description according to the protocol suggested by woodward et. al. (2006)
• Developmental assessment at 18 months corrected age [ Time Frame: 20-21 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
• S100b [ Time Frame: 2-3 months after recruitment ]
  The level of S100b in a sample of 0.5 cc saliva will collected every 2 days from the day of birth to discharge

Current Secondary Outcome:

• 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

Original Secondary Outcome:

• Glial fibrillary acidic protein [ Time Frame: 2-3 month after recruitment ]
  The level of GFAP in a blood sample of 0.3-0.5 cc will be collected weekly
• 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

Information By: Sheba Medical Center

Dates:
Date Received: February 11, 2014
Date Started: February 2014
Date Completion:
Last Updated: March 8, 2014
Last Verified: March 2014