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Intraventricular Hemorrhage clinical trials

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NCT ID: NCT03253263 Recruiting - Clinical trials for Bronchopulmonary Dysplasia

A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants

Start date: May 9, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if an investigational drug can prevent Bronchopulmonary Dysplasia, reducing the burden of chronic lung disease in extremely premature infants, as compared to extremely premature infants receiving standard neonatal care alone.

NCT ID: NCT02996799 Recruiting - PreTerm Birth Clinical Trials

Deferred Cord Clamping Compared to Umbilical Cord Milking in Preterm Infants

Start date: January 2017
Phase: N/A
Study type: Interventional

For preterm infants, deferred cord clamping has been shown to improve both short term and long-term neonatal outcomes without an established harm for both the mother and her infant.The interference with resuscitative measures for the neonate or the mother is a risk that continued to hamper the implementation of delayed cord clamping in many centers around the world.For that reason, the evidence now is seeking a time-honored, yet not adopted method of placental transfusion that involves milking of the umbilical cord.

NCT ID: NCT02988154 Recruiting - Hydrocephalus Clinical Trials

Simulation Efficacy in Neurosurgical Education

SENSE
Start date: June 2016
Phase: N/A
Study type: Observational

This study aims to investigate the efficacy of simulation in neurosurgical training.

NCT ID: NCT02814383 Recruiting - Brain Injury Clinical Trials

Prediction of Brain Injury in Premature Infants

Start date: August 11, 2016
Phase:
Study type: Observational

Extremely low birth weight (ELBW), birth weight less than or equal to 1000 g, infants are at high risk for developing brain injury in the first week of life. Intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL) are the most common injuries in this group of infants. Their incidence is inversely proportional to gestational age (GA) and birth weight (BW). These lesions are associated with neurodevelopmental delay, poor cognitive performance, visual and hearing impairment, epilepsy, and cerebral palsy; and instability of systemic hemodynamics during transition from intra- to extra-uterine life and during the early neonatal period is believed to be at their genesis. While the incidence of ultrasound- diagnosed cystic PVL has decreased dramatically over the last 2 decades, diffuse PVL detected by magnetic resonance imaging (MRI) is still prevalent in survivors of neonatal intensive care. Moreover, PVL, even when non-cystic, is associated with decreased cortical complexity and brain volume and eventual neurocognitive impairment. Currently, clinicians lack the tools to detect changes in cerebral perfusion prior to irreversible injury. Unfortunately, the incidence of brain injury in ELBW infants has remained relatively stable. Once translated to the bedside, the goal of this research is to develop a monitoring system that will allow researchers to identify infants most at risk for IVH and PVL and in the future, intervention studies will be initiated to use the changes in cerebral perfusion to direct hemodynamic management. The purpose of this study is to first understand the physiology of brain injury and then to eventually impact the outcomes in this high-risk group of infants by assessing the ability of the diastolic closing margin (DCM), a non-invasive estimate of brain perfusion pressure, to predict hemorrhagic and ischemic brain injury in ELBW infants. The information collected for this study will help develop algorithms or monitoring plans that will maintain the appropriate brain perfusion pressure and thereby, prevent severe brain injury.

NCT ID: NCT02400853 Recruiting - Clinical trials for Intraventricular Hemorrhage

Research a New Predictive Marker of Intraventricular Hemorrhage in Very Preterm Infants

HEMO PREMA
Start date: July 2015
Phase: N/A
Study type: Interventional

The most frequent complications in premature infants are neurological complications: intracranial hemorrhages and white matter lesions. In Epipage 2 study the incidence of severe intraventricular hemorrhages remains stable. Severe hemorrhages are associated with neurological sequelae. A recent study in humans and in animals shows the role of the complex formed by plasminogen activator (t-PA) and its inhibitor (PAI-1) in the induction of vascular fragility via stromelysin (MMP-3). FIBRINAT study in Rouen University Hospital showed a rate of complex t-PA-PAI1 probably very high in preterm infants. An other factor maturation PDGF-C induced by t-PA is associated with the vascular embrittlement. Among the few genetic factors associated with cerebral palsy include 2 SNP of PAI-1 gene and one SNP in the gene of endothelial NO synthase. The hypothesis is that a high rate of the complex t-PA-PAI-1 in cord blood could be a high risk of intracranial hemorrhage in preterm infants and provide predictive of their occurrence. The rates of MMP-3, PDGF-C and PAI-1 free in cord blood, and the polymorphism of PAI-1 gene and eNOS could separately or associated with the main criterion to identify predictive of hemorrhages. The main objective is to search a rate difference of the complex t-PA-PAI-1 in cord blood of preterm infants (before 30 weeks of gestation) that would predict intracranial hemorrhage coming in the first days of life. The secondary objectives are - Evaluate potential marker risk of high levels of MMP-3, PAI-1 free, and PDGF-CC - Search in both groups the presence of alleles -675G4 / G5 and 11053 (G / T) of the PAI-1 gene and -922 (A / G) of the eNOS gene. 120 preterm infants will be included before 30 weeks of gestation with precise inclusion and exclusion criteria during a period of 3 years. Patients will be divided into two groups according to whether they will or not showed intracranial hemorrhage (detected by ultrasound J5-J7). The complex rate tPA-PAI-1, PAI-1 free, MMP-3 and PDGF-C will be measured. The comparison between the two groups will be carried out using statistical tests. Comparison of the presence of the alleles -675 4G and 11053T the PAI-1 gene or -922G eNOS gene between the two groups will be performed. The demonstration of this hypothesis would permit to identify children from birth in whom the immediate implementation of preventive treatment of bleeding is desirable.

NCT ID: NCT01098890 Recruiting - Clinical trials for Aneurysmal Subarachnoid Hemorrhage

Intraventricular Tissue Plasminogen Activator (tPA) in the Management of Aneurysmal Subarachnoid Hemorrhage

Start date: October 2009
Phase: Phase 2
Study type: Interventional

The proposed study is to evaluate the acceleration the clearance of intraventricular blood (IVH) and subarachnoid hemorrhage (SAH) following ruptured intracranial aneurysms, thereby ameliorating complications, such as cerebral vasospasm, hydrocephalus and intracranial hypertension. The primary objectives are: 1. Estimate the rate and variance of hematoma clearance following aneurysmal SAH, thereby facilitating sample size determination for a subsequent larger study; 2. Assess the feasibility of a randomized controlled trial of intraventricular tissue plasminogen activator (TPA) among patients with SAH (enrollment rate, ability to blind investigators, protocol compliance); 3. Confirm the safety of intraventricular TPA.

NCT ID: NCT01064011 Recruiting - Clinical trials for Intraventricular Hemorrhage

Prospective Randomized, Controlled Trial for Treatment of Intraventricular Hemorrhage

IVH
Start date: January 2010
Phase: N/A
Study type: Interventional

Intraventricular hemorrhage comprises about 15% of the 500,000 strokes that occur annually in the United States. In the emergent setting, patients with obstructive hydrocephalus are routinely treated with placement of an external ventricular drain. This study will compare the effect of external ventricular drainage plus intraventricular thrombolysis versus external ventricular drainage plus endoscopic evacuation on neurologic outcomes for patients with hydrocephalus from intraventricular hemorrhage.