Clinical Trial: Prediction of Brain Injury in Premature Infants
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Diastolic Closing Margin Predicts Brain Injury in Premature Infants
Brief Summary:
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 hemorrha
Detailed Summary:
This is a prospective, single-center, data collection research study for premature ELBW infants at high risk of developing brain injury. This study is being done to evaluate the changes in brain perfusion measured by the DCM using a comprehensive and innovative brain monitoring platform that encompasses direct and continuous measures of cerebral blood flow (CBF), cerebral oximetry, cerebral autoregulation, partial pressure of carbon dioxide (PCO2), and arterial blood pressure (ABP) in the hopes to both describe the physiology of brain injury and to correlate these findings to short- and long-term outcomes relevant to ELBW infants.
About three hundred and ten (310) subjects are expected to be enrolled. Subjects' active participation in the study may last up to one week and the total time they will be followed after birth is approximately 24 months (2 years) depending on their prematurity. Information from the subjects' medical records may be accessed, reviewed, and recorded for an additional year after their final study visit. This study consists of about 5 study visits: Study Visit 1 (the enrollment visit), Study Visit 2 (occurs 2-7 days after the enrollment visit), Study Visit 3 (occurs approximately 2-4 months after the enrollment visit), Study Visit 4 (occurs approximately at 12 months after the enrollment visit), and Study Visit 5 (occurs approximately at 24 months after the enrollment visit).
STUDY ASSESSMENTS:
- Medical and Surgical History: The subjects' detailed history will be reviewed and recorded. The subjects' mothers will also be asked questions about their own medical history. The mothers' medical records may also be accessed.
- Continuous Physiologic Monitoring: Monitoring will be performed that i
Sponsor: Baylor College of Medicine
Current Primary Outcome: Brain Perfusion [ Time Frame: 1 Week ]
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.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Brain Perfusion [ Time Frame: 1 Week ]Brain perfusion will be assessed by calculating the systolic blood flow autoregulation.
- Brain Perfusion [ Time Frame: 1 Week ]Brain perfusion will be assessed by calculating the critical closing pressure (CrCP).
- Brain Injury (IVH) [ Time Frame: 1 Week ]The presence of IVH will be assessed by two head ultrasounds (HUS).
- Brain Injury (PVL) [ Time Frame: 7 Weeks ]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.
- Brain Injury (PVL) [ Time Frame: 7 Weeks ]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.
- Neurodevelopmental Function [ Time Frame: 12 Months ]Neurodevelopmental function will be assessed using the Bayley III motor subtest at 12 months.
- Neurodevelopmental Function [ Time Frame: 12 Months ]Neurodevelopmental function will be assessed using the neurologic exam at 12 months.
- Neurodevelopmental Function [ Time Frame: 12 Months ]Neurodevelopmental function will be assessed using the Capute Scales at 12 months.
- Neurodevelopmental Function [ Time Frame: 24 Months ]Neurodevelopmental function will be assessed using the Bayley III motor subtest at 18-24 Months.
- Neurodevelopmental Function [ Time Frame: 24 Months ]Neurodevelopmental function will be assessed using the Bayley III language subtest at 18-24 Months.
- Neurodevelopmental Function [ Time Frame: 24 Months ]Neurodevelopmental function will be assessed using the Bayley III cognitive subtest at 18-24 Months.
Original Secondary Outcome:
- Brain Perfusion [ Time Frame: 1 Week ]Brain perfusion will be assessed by calculating the systolic blood flow autoregulation.
- Brain Perfusion [ Time Frame: 1 Week ]Brain perfusion will be assessed by calculating the critical closing pressure (CrCP).
- Brain Injury (IVH) [ Time Frame: 1 Week ]The presence of IVH will be assessed by two head ultrasounds (HUS).
- Brain Injury (PVL) [ Time Frame: 7 Weeks ]The presence of PVL will be assessed by magnetic resonance imaging (MRI) at term-equivalent age (date on which patient reaches 40 weeks post-conception age) using conventional MRI.
- Brain Injury (PVL) [ Time Frame: 7 Weeks ]The presence of PVL will be assessed by magnetic resonance imaging (MRI) at term-equivalent age (date on which patient reaches 40 weeks post-conception age) using quantitative diffusion tensor imaging.
- Neurodevelopmental Function [ Time Frame: 12 Months ]Neurodevelopmental function will be assessed using the Bayley III motor subtest at 12 months.
- Neurodevelopmental Function [ Time Frame: 12 Months ]Neurodevelopmental function will be assessed using the neurologic exam at 12 months.
- Neurodevelopmental Function [ Time Frame: 12 Months ]Neurodevelopmental function will be assessed using the Capute Scales at 12 months.
- Neurodevelopmental Function [ Time Frame: 24 Months ]Neurodevelopmental function will be assessed using the Bayley III motor subtest at 18-24 Months.
- Neurodevelopmental Function [ Time Frame: 24 Months ]Neurodevelopmental function will be assessed using the Bayley III language subtest at 18-24 Months.
- Neurodevelopmental Function [ Time Frame: 24 Months ]Neurodevelopmental function will be assessed using the Bayley III cognitive subtest at 18-24 Months.
Information By: Baylor College of Medicine
Dates:
Date Received: May 26, 2016
Date Started: May 2016
Date Completion: May 2020
Last Updated: March 21, 2017
Last Verified: March 2017
- Brain Perfusion [ Time Frame: 1 Week ]
