Intraventricular HemorrhageNCT02814383
Prediction of Brain Injury in Premature Infants
An observational study of Intraventricular Hemorrhage and Periventricular Leukomalacia, run by Baylor College of Medicine at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 12 hours
- Conditions the study is for
- Intraventricular Hemorrhage, Periventricular Leukomalacia, Brain Injury
- What is being tested?
- Brain Monitoring Platform
- How many people
- 70 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Aug 2016to 23 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 12 hours
- All sexes
- No healthy volunteers
- Child
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Baylor College of Medicine
Houston, Texas, 77030
Texas Children's Hospital
Houston, Texas, 77030
Texas Children's Pavilion for Women
Houston, Texas, 77030
About this study
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.
Read the detailed description
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:
- 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 includes the transcranial Doppler ultrasound, near-infrared spectroscopy (NIRS), and partial pressure of carbon dioxide (PCO2) from birth to 7 days of life (visits 1 and 2).
- Ventilator: The highest daily ventilator settings and mean airway pressure (MAP) will be reviewed and recorded from birth to 7 days of life (visits 1 and 2).
- Head Ultrasound: A head ultrasound will be performed upon enrollment (visit 1) to assess for early and preexisting brain injury (IVH).
- Adverse Events: Any adverse events (AEs), special events of interest, or unanticipated problems (UPs) that subjects may have experienced after enrollment will be reviewed and recorded (visits 1, 2, 3, 4, and 5).
- Concomitant Medications: Review and record any medications of interest that subjects are taking from birth to 7 days of life (visits 1 and 2).
- Blood Transfusions: Review and record the transfusion of blood products that are performed on the subjects as part of standard of care from birth to 7 days of life (visits 1 and 2).
- Echocardiogram (ECG) and Head Ultrasound: Review and record ECG and head ultrasound results that are performed on the subjects as part of standard of care from birth to 7 days of life (visits 1 and 2).
- Respiratory Interventions and Suctioning: Review and record any respiratory interventions and/or suctioning that are performed on the subjects as part of standard of care from birth to 7 days of life (visits 1 and 2).
- Magnetic Resonance Imaging (MRI): Perform a MRI exam at visit 3 or up to the time of discharge.
- Capute Scales and Neurologic Exam: Perform this assessment at visit 4 to assess the subjects' development and cognitive function and to provide an early evaluation for any neurologic abnormalities that may be related to brain injury.
- Bayley-III Motor Sub-Test Exam: Perform this assessment at visit 4 to assess the subjects' development and cognitive function and to provide an early evaluation for any neurologic abnormalities that may be related to brain injury.
- Complete Bayley-III Exam: Perform this assessment at visit 5 to assess the subjects' development and cognitive function and to provide an early evaluation for any neurologic abnormalities that may be related to brain injury.
- Conditions
- Intraventricular Hemorrhage, Periventricular Leukomalacia, Brain Injury, Extreme Prematurity
- Being tested
- Brain Monitoring Platform
- Keywords
- Prematurity, Extremely Low Birth Weight (ELBW), Cerebral Perfusion, Cerebral Autoregulation
- Medical subject headings
- Leukomalacia, Periventricular, Brain Injuries, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Monitoring PlatformOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Brain Monitoring Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Week
Secondary outcomes (11)
Brain Perfusion
Brain perfusion will be assessed by calculating the systolic blood flow autoregulation.
Measured: 1 Week
Brain Perfusion
Brain perfusion will be assessed by calculating the critical closing pressure (CrCP).
Measured: 1 Week
Brain Injury (IVH)
The presence of IVH will be assessed by two head ultrasounds (HUS).
Measured: 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.
Measured: 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.
Measured: 7 Weeks
Neurodevelopmental Function
Neurodevelopmental function will be assessed using the Bayley III motor subtest at 12 months.
Measured: 12 Months
Neurodevelopmental Function
Neurodevelopmental function will be assessed using the neurologic exam at 12 months.
Measured: 12 Months
Neurodevelopmental Function
Neurodevelopmental function will be assessed using the Capute Scales at 12 months.
Measured: 12 Months
Neurodevelopmental Function
Neurodevelopmental function will be assessed using the Bayley III motor subtest at 18-24 Months.
Measured: 24 Months
Neurodevelopmental Function
Neurodevelopmental function will be assessed using the Bayley III language subtest at 18-24 Months.
Measured: 24 Months
Neurodevelopmental Function
Neurodevelopmental function will be assessed using the Bayley III cognitive subtest at 18-24 Months.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study start11 Aug 2016
- Primary completion21 May 2025
- Study completion23 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraventricular HemorrhageStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher J. Rhee, MD, MS, Baylor College of Medicine
- Investigators
- Christopher J. Rhee, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02814383
- Sponsor's protocol ID
- H-38084
- Other IDs
- K23NS091382
- Status last verified
- Jun 2026
- First submitted
- 26 May 2016
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diastolic Closing Margin Predicts Brain Injury in Premature Infants
- ClinicalTrials.gov ID
- NCT02814383
- Acronym / sponsor ID
- H-38084
- Conditions
- Intraventricular Hemorrhage, Periventricular Leukomalacia, Brain Injury, Extreme Prematurity
- Keywords
- Prematurity, Extremely Low Birth Weight (ELBW), Cerebral Perfusion, Cerebral Autoregulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 11 Aug 2016 (actual)
- Primary completion
- 21 May 2025 (actual)
- Study completion
- 23 Sep 2025 (actual)
- First posted
- 27 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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 includes the transcranial Doppler ultrasound, near-infrared spectroscopy (NIRS), and partial pressure of carbon dioxide (PCO2) from birth to 7 days of life (visits 1 and 2).
- Ventilator: The highest daily ventilator settings and mean airway pressure (MAP) will be reviewed and recorded from birth to 7 days of life (visits 1 and 2).
- Head Ultrasound: A head ultrasound will be performed upon enrollment (visit 1) to assess for early and preexisting brain injury (IVH).
- Adverse Events: Any adverse events (AEs), special events of interest, or unanticipated problems (UPs) that subjects may have experienced after enrollment will be reviewed and recorded (visits 1, 2, 3, 4, and 5).
- Concomitant Medications: Review and record any medications of interest that subjects are taking from birth to 7 days of life (visits 1 and 2).
- Blood Transfusions: Review and record the transfusion of blood products that are performed on the subjects as part of standard of care from birth to 7 days of life (visits 1 and 2).
- Echocardiogram (ECG) and Head Ultrasound: Review and record ECG and head ultrasound results that are performed on the subjects as part of standard of care from birth to 7 days of life (visits 1 and 2).
- Respiratory Interventions and Suctioning: Review and record any respiratory interventions and/or suctioning that are performed on the subjects as part of standard of care from birth to 7 days of life (visits 1 and 2).
- Magnetic Resonance Imaging (MRI): Perform a MRI exam at visit 3 or up to the time of discharge.
- Capute Scales and Neurologic Exam: Perform this assessment at visit 4 to assess the subjects' development and cognitive function and to provide an early evaluation for any neurologic abnormalities that may be related to brain injury.
- Bayley-III Motor Sub-Test Exam: Perform this assessment at visit 4 to assess the subjects' development and cognitive function and to provide an early evaluation for any neurologic abnormalities that may be related to brain injury.
- Complete Bayley-III Exam: Perform this assessment at visit 5 to assess the subjects' development and cognitive function and to provide an early evaluation for any neurologic abnormalities that may be related to brain injury.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ELBW Infants | – | Other: Brain Monitoring PlatformThis study seeks to collect data on premature ELBW infants (less than or equal to 2.2 lbs) at high risk of developing brain injury. |
Who may qualify
- Ages
- 0 to 12 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- Complex congenital anomalies of central nervous system (CNS)
- Complex chromosomal congenital anomalies
- Hydrops fetalis
- Poor skin integrity
- Live-born but receiving only comfort care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain Monitoring PlatformThis 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). | Other | ELBW Infants |
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.
11 secondary outcomes
Brain Perfusion
Time frame: 1 Week
Brain Perfusion
Time frame: 1 Week
Brain Injury (IVH)
Time frame: 1 Week
Brain Injury (PVL)
Time frame: 7 Weeks
Brain Injury (PVL)
Time frame: 7 Weeks
Neurodevelopmental Function
Time frame: 12 Months
Neurodevelopmental Function
Time frame: 12 Months
Neurodevelopmental Function
Time frame: 12 Months
Neurodevelopmental Function
Time frame: 24 Months
Neurodevelopmental Function
Time frame: 24 Months
Neurodevelopmental Function
Time frame: 24 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Description Dr. Rhee's Profile PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Intraventricular Hemorrhage
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
The Correlation Between Red Cell Transfusion and Complications of Prematurity
Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD)
Enrolling by invitationObservational study
Intelligent Physiological Monitoring to Predict Preterm Brain Injury
Cerebral Palsy (CP), Intraventricular Hemorrhage Neonatal
Active, not recruiting
Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
IVH- Intraventricular Hemorrhage, Extreme Prematurity
Active, not recruiting
aSAH Treatment Based on Intraventricular ICP Monitoring: A Prospective, Multicenter, Randomized and Controlled Trial
Aneurysmal Subarachnoid Hemorrhage, Intacranial Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher J. Rhee, MD principal investigator
Baylor College of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraventricular Hemorrhage and Periventricular Leukomalacia, run by Baylor College of Medicine at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain Perfusion (time frame: 1 Week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.