Premature Birth Clinical Trial
Official title:
S100B as a Marker of Brain Injury of Preterm Infants
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.
n/a
Observational Model: Cohort, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05048550 -
Babies in Glasses; a Feasibility Study.
|
N/A | |
Active, not recruiting |
NCT03655639 -
Local Version of the Multi-center PREVENT Study Evaluating Cardio-respiratory Instability in Premature Infants
|
||
Enrolling by invitation |
NCT05542108 -
Adding Motion to Contact: A New Model for Low-cost Family Centered Very-early Onset Intervention in Very Preterm-born Infants
|
N/A | |
Completed |
NCT03680157 -
Comparing Rater Reliability of Familiar Practitioners to Blinded Coders
|
||
Completed |
NCT03337659 -
A Cluster Randomized Controlled Trial of FICare at 18 Months
|
N/A | |
Completed |
NCT03649932 -
Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing
|
Phase 1 | |
Completed |
NCT03251729 -
Cerclage On LOw Risk Singletons: Cervical Cerclage for Prevention of Spontaneous Preterm Birth in Low Risk Singleton Pregnancies With Short Cervix
|
Phase 4 | |
Not yet recruiting |
NCT05039918 -
Neonatal Experience of Social Touch
|
N/A | |
Not yet recruiting |
NCT03418311 -
Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children`s Long-Term Outcome
|
N/A | |
Not yet recruiting |
NCT03418012 -
Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB
|
N/A | |
Completed |
NCT02952950 -
Is it Possible to Prolong the Duration of Breastfeeding in Premature Infants? a Prospectivt Study
|
N/A | |
Completed |
NCT02913495 -
Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth
|
Phase 4 | |
Not yet recruiting |
NCT02880696 -
Perception of Temporal Regularity in Tactile Stimulation: a Diffuse Correlation Spectroscopy Study in Preterm Neonates
|
N/A | |
Completed |
NCT02879799 -
Family Integrated Care (FICare) in Level II NICUs
|
N/A | |
Completed |
NCT02743572 -
Iron-fortified Parenteral Nutrition in the Prevention and Treatment of Anemia in Premature Infants
|
N/A | |
Completed |
NCT02661360 -
Effects of Swaddling on Infants During Feeding
|
N/A | |
Completed |
NCT01352234 -
Comparison of Doses of Acetylsalicylic Acid in Women With Previous History of Preeclampsia
|
Phase 4 | |
Completed |
NCT01163188 -
Social Adjustment and Quality of Life After Very Preterm Birth
|
N/A | |
Terminated |
NCT00675753 -
Three Interacting Single Nucleotide Polymorphisms (SNPs) and the Risk of Preterm Birth in Black Families
|
N/A | |
Terminated |
NCT00179972 -
Evaluation of Pulse Oximetry Sensors in Neonates
|
N/A |