Clinical trial NCT02082535: S100B as a Marker of Brain Injury of Preterm Infants
Official title: S100B as a Marker of Brain Injury of Preterm Infants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-03-10
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Very early preterm infants born before 30 weeks gestational age

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.


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

Primary outcomes:
measure: MRI at term age
timeFrame: 2-3 month after recruitment
measure: S100b and GFAP
timeFrame: 2-3 months after recruitment
Secondary outcomes:
measure: Developmental assessment at 18 month
timeFrame: 21 month after recruitment
measure: Developmental assessment at 3 month corrected age
timeFrame: 5-6 months after recuitment
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba medical center
Study officials:
affiliation: Sheba Medical Center, Ramat Gan, Israel
name: Omer Bar Yosef, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: