Brain Injury Clinical Trial
Official title:
Diastolic Closing Margin Predicts Brain Injury in Premature Infants
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.
Status | Recruiting |
Enrollment | 310 |
Est. completion date | March 2025 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 0 Hours to 12 Hours |
Eligibility | Inclusion Criteria: - Informed consent obtained from parent or legally authorized representative (LAR) - Live-born ELBW infant - Less than 12 hours of life - Birth weight 401 to 1000g - Admitted to Texas Children's Hospital (TCH) Pavilion for Women (PFW) Neonatal Intensive Care Unit (NICU) - Umbilical arterial catheter (UAC) in place Exclusion Criteria: - Complex congenital anomalies of central nervous system (CNS) - Complex chromosomal congenital anomalies - Hydrops fetalis - Poor skin integrity - Live-born but receiving only comfort care - Grade 3-4 IVH by head ultrasound (HUS) at the first ultrasound completed at or before 12 hours of life |
Country | Name | City | State |
---|---|---|---|
United States | Baylor College of Medicine | Houston | Texas |
United States | Texas Children's Hospital | Houston | Texas |
United States | Texas Children's Pavilion for Women | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine | National Institute of Neurological Disorders and Stroke (NINDS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Brain Perfusion | Brain perfusion will be assessed by calculating the diastolic closing margin (DCM). DCM will be measured from continuous recordings of middle cerebral artery cerebral blood flow velocity (CBFV) by transcranial Doppler ultrasound and ABP during first week of life for ELBW infants. | 1 Week | |
Secondary | Brain Perfusion | Brain perfusion will be assessed by calculating the systolic blood flow autoregulation. | 1 Week | |
Secondary | Brain Perfusion | Brain perfusion will be assessed by calculating the critical closing pressure (CrCP). | 1 Week | |
Secondary | Brain Injury (IVH) | The presence of IVH will be assessed by two head ultrasounds (HUS). | 1 Week | |
Secondary | Brain Injury (PVL) | The presence of PVL will be assessed by magnetic resonance imaging (MRI) at term-equivalent age (date on which patient reaches 37 to 40 weeks post-conception age) using conventional MRI. | 7 Weeks | |
Secondary | Brain Injury (PVL) | The presence of PVL will be assessed by magnetic resonance imaging (MRI) at term-equivalent age (date on which patient reaches 37 to 40 weeks post-conception age) using quantitative diffusion tensor imaging. | 7 Weeks | |
Secondary | Neurodevelopmental Function | Neurodevelopmental function will be assessed using the Bayley III motor subtest at 12 months. | 12 Months | |
Secondary | Neurodevelopmental Function | Neurodevelopmental function will be assessed using the neurologic exam at 12 months. | 12 Months | |
Secondary | Neurodevelopmental Function | Neurodevelopmental function will be assessed using the Capute Scales at 12 months. | 12 Months | |
Secondary | Neurodevelopmental Function | Neurodevelopmental function will be assessed using the Bayley III motor subtest at 18-24 Months. | 24 Months | |
Secondary | Neurodevelopmental Function | Neurodevelopmental function will be assessed using the Bayley III language subtest at 18-24 Months. | 24 Months | |
Secondary | Neurodevelopmental Function | Neurodevelopmental function will be assessed using the Bayley III cognitive subtest at 18-24 Months. | 24 Months |
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