An observational study in Intraventricular Hemorrhage, Periventricular Leukomalacia and Brain Injury, sponsored by Baylor College of Medicine. Completed at 3 sites in United States. Open to participants aged 0 Hours to 12 Hours. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Baylor College of Medicine · 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.
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) or more (+/- 2 Months) 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 - within first 12 hours of life), Study Visit 2 (occurs 2-7 days post visit 1), Study Visit 3 (occurs approximately 2-4 months +/- 2 Months term equivalent age/corrected age of the subject ), Study Visit 4 (occurs approximately at 12 months +/- 2 Months corrected age of the subject), and Study Visit 5 (occurs approximately at 18-24 months +/- 2 Months chronological age of the subject).
STUDY ASSESSMENTS:
40 studies on the registry are indexed under Leukomalacia, Periventricular; 5 are open to participants now.
This study's enrollment of 70 is close to the median of 66 across 10 observational studies indexed under Leukomalacia, Periventricular.
Browse Leukomalacia, Periventricular studies →Baylor College of Medicine is the lead sponsor of 747 studies on the registry; 110 are open to participants now.
Of its 84 completed or terminated interventional studies of FDA-regulated products, 45 (54%) have results posted.
Counted across the registry records on this site, refreshed daily.
Within 12 hours of life, subjects' mothers will be approached for participation in this research study. This study seeks to collect data on premature ELBW infants (less than or equal to 2.2 lbs) at high risk of developing brain injury.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This study seeks to collect data on premature ELBW infants (less than or equal to 2.2 lbs) at high risk of developing brain injury.
Other: Brain Monitoring Platform
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).
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.
Time frame: 1 Week
Brain Perfusion
Brain perfusion will be assessed by calculating the systolic blood flow autoregulation.
Time frame: 1 Week
Brain Perfusion
Brain perfusion will be assessed by calculating the critical closing pressure (CrCP).
Time frame: 1 Week
Brain Injury (IVH)
The presence of IVH will be assessed by two head ultrasounds (HUS).
Time frame: 1 Week
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.
Time frame: 7 Weeks
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.
Time frame: 7 Weeks
Neurodevelopmental Function
Neurodevelopmental function will be assessed using the Bayley III motor subtest at 12 months.
Time frame: 12 Months
Neurodevelopmental Function
Neurodevelopmental function will be assessed using the neurologic exam at 12 months.
Time frame: 12 Months
Neurodevelopmental Function
Neurodevelopmental function will be assessed using the Capute Scales at 12 months.
Time frame: 12 Months
Neurodevelopmental Function
Neurodevelopmental function will be assessed using the Bayley III motor subtest at 18-24 Months.
Time frame: 24 Months
Neurodevelopmental Function
Neurodevelopmental function will be assessed using the Bayley III language subtest at 18-24 Months.
Time frame: 24 Months
Neurodevelopmental Function
Neurodevelopmental function will be assessed using the Bayley III cognitive subtest at 18-24 Months.
Time frame: 24 Months
Plan to share: No
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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