S100B as a Marker of Brain Injury of Preterm Infants

Premature Birth Clinical Trial

— PTS100B  

Official title:

S100B as a Marker of Brain Injury of Preterm Infants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02082535
• Other study ID #: SHEBA-13-0044-0B-CTIL
• Status: Recruiting
• Phase: N/A
• First received: February 11, 2014
• Last updated: March 8, 2014
• Start date: February 2014

Study information

• Verified date: March 2014
• Source: Sheba Medical Center
• Contact: Omer Bar Yosef, M.D. Ph.D.
• Phone: 972-526667344
• Email: omer.baryosef[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Days

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Israel	Sheba medical center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI at term age	MRI description according to the protocol suggested by woodward et. al. (2006)	2-3 month after recruitment	No
Primary	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	No
Secondary	Developmental assessment at 18 month	Neurological examination Griffith mental developmental scales (GMD-2) Vineland adaptive behavioral scale (VinelandTM-II) Clinical Adaptive Test/Clinical Linguistic and Auditory Milestone Scale	21 month after recruitment	No
Secondary	Developmental assessment at 3 month corrected age	Neurological examination General Movements assessment Griffith mental developmental scales (GMD-2) Clinical Adaptive Test/Clinical Linguistic and Auditory Milestone Scale	5-6 months after recuitment	No