HIE - Perinatal Hypoxic - Ischemic EncephalopathyNCT03835039
The Ability of NIRS to Predict Brain Injury in Hypoxic Ischemic Encephalopathy
An observational study of HIE - Perinatal Hypoxic - Ischemic Encephalopathy, run by Albany Medical College at 1 site in United States.
Trial summary
A longitudinal study evaluating the predictive ability of near infrared spectroscopy to predict brain injury in infants with hypoxic ischemic encephalopathy. Data will be analyzed at two different time periods, at discharge and again at 2 years of age. Read more about this study
- Who is it for?
- Ages 1 minute to 2 years
- Conditions the study is for
- HIE - Perinatal Hypoxic - Ischemic Encephalopathy
- What is being tested?
- NIRS
- Type of treatment
- Medical device
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2019to 1 Jan 2022
- 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 1 minute to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: Newborn infants with diagnosis of HIE
Who may be able to join
- Infants with diagnosis at birth of HIE
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Albany Medical Center Neonatal Intesive Care Unit
Albany, New York, 12208
About this study
Official title: The Ability of Near Infrared Spectroscopy Monitoring During Hypothermia Treatment to Predict Brain Injury in Infants With Hypoxic Ischemic Encephalopathy
A longitudinal study evaluating the predictive ability of near infrared spectroscopy to predict brain injury in infants with hypoxic ischemic encephalopathy. Data will be analyzed at two different time periods, at discharge and again at 2 years of age.
- Being tested
- NIRS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRSDevice
Monitoring cerebral and perirenal perfusion using NIRS
| Study group | Role | What they receive |
|---|---|---|
| HIE | Infants with a diagnosis of HIE Receives: Device: NIRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI findings of encephalopathy
MRI studies will be reviewed and assessed for markers of HIE including damage to deep grey matter structures.
Measured: 6 days
Neurodevelopment at 2 years of age
Bayleys developmental test will be used to categorize the infants' neurodevelopment at 2 years of age.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start3 Jan 2019
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Why it stopped: Interim analysis not showing significant results
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIE - Perinatal Hypoxic - Ischemic EncephalopathyStudies of the same condition, open and under way.
- 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
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835039
- Sponsor's protocol ID
- 5120
- Status last verified
- Feb 2022
- First submitted
- 18 Jan 2019
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ability of Near Infrared Spectroscopy Monitoring During Hypothermia Treatment to Predict Brain Injury in Infants With Hypoxic Ischemic Encephalopathy
- ClinicalTrials.gov ID
- NCT03835039
- Acronym / sponsor ID
- 5120
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Interim analysis not showing significant results
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 8 Feb 2019 (actual)
- 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.
A longitudinal study evaluating the predictive ability of near infrared spectroscopy to predict brain injury in infants with hypoxic ischemic encephalopathy. Data will be analyzed at two different time periods, at discharge and again at 2 years of age.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIE | – | Device: NIRSInfants with a diagnosis of HIE |
Who may qualify
- Ages
- 1 minute to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Newborn infants with diagnosis of HIE
Key inclusion criteria (1 listed)
- Infants with diagnosis at birth of HIE
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| NIRSMonitoring cerebral and perirenal perfusion using NIRS | Device | HIE |
Primary outcome
MRI findings of encephalopathy
Time frame: 6 days
MRI studies will be reviewed and assessed for markers of HIE including damage to deep grey matter structures.
Neurodevelopment at 2 years of age
Time frame: 2 years
Bayleys developmental test will be used to categorize the infants' neurodevelopment at 2 years of age.
Results and safety
The study was stopped early (reason given: Interim analysis not showing significant results). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Individual participant dataSharing planned: No
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Mesenchymal Stem Cells With Cooling Therapy for Infants With Hypoxic-Ischemic Encephalopathy
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIE - Perinatal Hypoxic - Ischemic Encephalopathy, run by Albany Medical College at 1 site 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Interim analysis not showing significant results). Results are not available in the source record.
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?
MRI findings of encephalopathy (time frame: 6 days). The study lists 2 primary outcomes in all. 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 15 Mar 2022.