Prediction of Brain Injury in Premature Infants
Diastolic Closing Margin Predicts Brain Injury in Premature Infants
2 other identifiers
observational
310
1 country
3
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2016
Longer than P75 for all trials
3 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2016
CompletedFirst Posted
Study publicly available on registry
June 27, 2016
CompletedStudy Start
First participant enrolled
August 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 21, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 21, 2025
CompletedMay 23, 2025
May 1, 2025
8.8 years
May 26, 2016
May 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (11)
Brain Perfusion
1 Week
Brain Perfusion
1 Week
Brain Injury (IVH)
1 Week
Brain Injury (PVL)
7 Weeks
Brain Injury (PVL)
7 Weeks
- +6 more secondary outcomes
Study Arms (1)
ELBW Infants
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.
Interventions
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).
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Baylor College of Medicine
Houston, Texas, 77030, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Texas Children's Pavilion for Women
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher J. Rhee, MD
Baylor College of Medicine
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
May 26, 2016
First Posted
June 27, 2016
Study Start
August 11, 2016
Primary Completion
May 21, 2025
Study Completion
May 21, 2025
Last Updated
May 23, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share