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NCT02814383 · ClinicalTrials.gov registry record
Prediction of Brain Injury in Premature Infants
A clinical trial of Intraventricular Hemorrhage and Brain Injury, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- 310
- Enrollment target
- 3
- Study locations
NCT02814383 is a study of Intraventricular Hemorrhage and Brain Injury that has completed, run by Baylor College of Medicine. The registered enrollment target is 310 participants, below the 1,185-participant average among 11 other Intraventricular Hemorrhage trials with a reported enrollment target (74% lower). The trial reports 3 study locations across 1 state.
The verdict
NCT02814383, a study of Intraventricular Hemorrhage and Brain Injury, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- 310 participants
- Enrollment target
- 3
- Study locations
Study 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 wi
Conditions Studied
Interventions
- OTHER Brain Monitoring Platform
Study Locations (3)
Texas
- Baylor College of Medicine - Houston
- Texas Children's Hospital - Houston
- Texas Children's Pavilion for Women - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 310 participants |
| Start Date | 2016-08-11 |
| Est. Completion | 2025-05-21 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02814383
The ClinicalTrials.gov registry entry for NCT02814383 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 310 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,185-participant average among 11 other Intraventricular Hemorrhage trials with a reported enrollment target (74% lower). The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Intraventricular Hemorrhage appearing as the primary indexed condition, and to 1 intervention - of which Brain Monitoring Platform is the first listed.
NCT02814383 reports 3 study locations spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT02814383 about?
NCT02814383 is a clinical study titled "Prediction of 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 incidenc...
What is the current status of trial NCT02814383?
This trial is currently completed. The enrollment target is 310 participants. The study started on 2016-08-11. Estimated completion is 2025-05-21.
What conditions does trial NCT02814383 study?
This clinical trial studies the following conditions: Intraventricular Hemorrhage, Brain Injury, Extreme Prematurity, Periventricular Leukomalacia.
What interventions are being tested in trial NCT02814383?
The interventions under investigation include: Brain Monitoring Platform (OTHER).
Who is sponsoring clinical trial NCT02814383?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02814383 being conducted?
This trial has 3 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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