Intraventricular Hemorrhage of PrematurityEarly NIRSNCT02147769
Cerebral Oxygenation and Autoregulation in Preterm Infants
An observational study of Intraventricular Hemorrhage of Prematurity and Complications of Prematurity, run by Stanford University at 7 sites in United States.
Trial summary
Premature infants are at high risk for variations in blood pressure and oxygenation during the first few days of life. The immaturity of the premature brain may further predispose these infants to death or the development of neurologic problems. Read more about this study
- Who is it for?
- Ages Up to 24 hours
- Conditions the study is for
- Intraventricular Hemorrhage of Prematurity, Complications of Prematurity
- What is being tested?
- NIRS monitoring
- Type of treatment
- Medical device
- How many people
- 111 participants
- Where
- 7 sitesUnited States
- Study dates
- May 2014to Mar 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 24 hours
- All sexes
- No healthy volunteers
- Child
Study population: All inborn preterm infants with birth weight <=1250 grams and with an indwelling arterial catheter already in place are eligible for study enrollment if they are <24 hours old at the time of enrollment. These preterm infants are at risk for impaired cerebral autoregulation and may undergo non-invasive monitoring of cerebral oxygenation using near-infrared spectroscopy (NIRS).
Who may be able to join
- inborn
- birth weight <= 1250 grams
- indwelling arterial catheter in place
- age <24 hours old
Who cannot join
- lethal chromosomal abnormality
- major congenital anomaly
- skin integrity insufficient to allow placement of NIRS sensors
- decision to not provide full intensive care
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Alabama
Birmingham, Alabama, 35249
Nationwide Children's Hospital
Columbus, Ohio, 43205
UT Southwestern Medical Center
Dallas, Texas, 75390
Yale-New Haven Children's Hospital
New Haven, Connecticut, 06520
Stanford University
Palo Alto, California, 94304
Santa Clara Valley Medical Center
San Jose, California, 95128
St. John's Children's Hospital
Springfield, Illinois, 62702
About this study
Official title: Cerebral Oxygenation and Autoregulation in Preterm Infants: Association With Morbidity and Mortality
Premature infants are at high risk for variations in blood pressure and oxygenation during the first few days of life. The immaturity of the premature brain may further predispose these infants to death or the development of neurologic problems. The relationship between unstable blood pressure and oxygen levels and brain injury has not been well elucidated.
This study investigates the utility of near-infrared spectroscopy (NIRS), a non-invasive oxygen-measuring device, to identify preterm infants at highest risk for brain injury or death.
- Being tested
- NIRS monitoring
- Keywords
- cerebral autoregulation, preterm, near-infrared spectroscopy
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRS monitoringDevice
All enrolled infants will undergo NIRS monitoring of cerebral oxygenation in addition to monitoring of continuous arterial blood pressure.
| Study group | Role | What they receive |
|---|---|---|
| Preterm infants monitored with NIRS | All infants enrolled in the study will be monitored with cerebral near-infrared spectroscopy (NIRS monitoring) to measure cerebral oxygenation levels in the first 96 hours of life. Mean arterial blood pressure will simultaneously be monitored. Receives: Device: NIRS monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality Before Hospital Discharge
Participants will be followed for the outcome of death prior to hospital discharge.
Measured: Outcome measure will be assessed at the time of subject's initial discharge from the hospital (on average by 40 weeks postmenstrual age), but at a maximum of 1 year of life.
Severe Central Nervous System (CNS) Morbidity
Routine cranial ultrasound obtained within the first ten days of life will be utilized to detect grade 3 or 4 intraventricular hemorrhage, periventricular leukomalacia, significant ventriculomegaly, or white matter abnormalities.
Measured: Outcome measure will be assessed on day 10 of life. Participants will be followed for neuroradiographic evidence of CNS morbidity in the first ten days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Intraventricular Hemorrhage of PrematurityStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Responsible party
- Principal investigator, Valerie Chock, M.D., M.S. Epi, Stanford University
- Investigators
- Valerie Chock, MD, Principal investigator, Stanford UniversityKrisa Van Meurs, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147769
- Sponsor's protocol ID
- 23894
- Acronym
- Early NIRS
- Status last verified
- Apr 2020
- First submitted
- 21 May 2014
- Last updated
- 7 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Verhagen EA, Hummel LA, Bos AF, Kooi EM. Near-infrared spectroscopy to detect absence of cerebrovascular autoregulation in preterm infants. Clin Neurophysiol. 2014 Jan;125(1):47-52. doi: 10.1016/j.clinph.2013.07.001. Epub 2013 Aug 22.
PubMed 23973384Alderliesten T, Lemmers PM, Smarius JJ, van de Vosse RE, Baerts W, van Bel F. Cerebral oxygenation, extraction, and autoregulation in very preterm infants who develop peri-intraventricular hemorrhage. J Pediatr. 2013 Apr;162(4):698-704.e2. doi: 10.1016/j.jpeds.2012.09.038. Epub 2012 Nov 6.
PubMed 23140883Soul JS, Hammer PE, Tsuji M, Saul JP, Bassan H, Limperopoulos C, Disalvo DN, Moore M, Akins P, Ringer S, Volpe JJ, Trachtenberg F, du Plessis AJ. Fluctuating pressure-passivity is common in the cerebral circulation of sick premature infants. Pediatr Res. 2007 Apr;61(4):467-73. doi: 10.1203/pdr.0b013e31803237f6.
PubMed 17515873Wong FY, Silas R, Hew S, Samarasinghe T, Walker AM. Cerebral oxygenation is highly sensitive to blood pressure variability in sick preterm infants. PLoS One. 2012;7(8):e43165. doi: 10.1371/journal.pone.0043165. Epub 2012 Aug 14.
PubMed 22905222Caicedo A, De Smet D, Naulaers G, Ameye L, Vanderhaegen J, Lemmers P, Van Bel F, Van Huffel S. Cerebral tissue oxygenation and regional oxygen saturation can be used to study cerebral autoregulation in prematurely born infants. Pediatr Res. 2011 Jun;69(6):548-53. doi: 10.1203/PDR.0b013e3182176d85.
PubMed 21364491Wong FY, Leung TS, Austin T, Wilkinson M, Meek JH, Wyatt JS, Walker AM. Impaired autoregulation in preterm infants identified by using spatially resolved spectroscopy. Pediatrics. 2008 Mar;121(3):e604-11. doi: 10.1542/peds.2007-1487. Epub 2008 Feb 4.
PubMed 18250118
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Oxygenation and Autoregulation in Preterm Infants: Association With Morbidity and Mortality
- ClinicalTrials.gov ID
- NCT02147769
- Acronym / sponsor ID
- Early NIRS / 23894
- Keywords
- cerebral autoregulation, preterm, near-infrared spectroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- May 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 28 May 2014 (estimated)
- Results
- Posted 7 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Premature infants are at high risk for variations in blood pressure and oxygenation during the first few days of life. The immaturity of the premature brain may further predispose these infants to death or the development of neurologic problems. The relationship between unstable blood pressure and oxygen levels and brain injury has not been well elucidated.
This study investigates the utility of near-infrared spectroscopy (NIRS), a non-invasive oxygen-measuring device, to identify preterm infants at highest risk for brain injury or death.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm infants monitored with NIRS | – | Device: NIRS monitoringAll infants enrolled in the study will be monitored with cerebral near-infrared spectroscopy (NIRS monitoring) to measure cerebral oxygenation levels in the first 96 hours of life. Mean arterial blood pressure will simultaneously be monitored. |
Who may qualify
- Ages
- Up to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All inborn preterm infants with birth weight <=1250 grams and with an indwelling arterial catheter already in place are eligible for study enrollment if they are <24 hours old at the time of enrollment. These preterm infants are at risk for impaired cerebral autoregulation and may undergo non-invasive monitoring of cerebral oxygenation using near-infrared spectroscopy (NIRS).
Key inclusion criteria (4 listed)
- inborn
- birth weight <= 1250 grams
- indwelling arterial catheter in place
- age <24 hours old
Key exclusion criteria (4 listed)
- lethal chromosomal abnormality
- major congenital anomaly
- skin integrity insufficient to allow placement of NIRS sensors
- decision to not provide full intensive 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 |
|---|---|---|
| NIRS monitoringAll enrolled infants will undergo NIRS monitoring of cerebral oxygenation in addition to monitoring of continuous arterial blood pressure. | Device | Preterm infants monitored with NIRS |
Primary outcome
Mortality Before Hospital Discharge
Time frame: Outcome measure will be assessed at the time of subject's initial discharge from the hospital (on average by 40 weeks postmenstrual age), but at a maximum of 1 year of life.
Participants will be followed for the outcome of death prior to hospital discharge.
Severe Central Nervous System (CNS) Morbidity
Time frame: Outcome measure will be assessed on day 10 of life. Participants will be followed for neuroradiographic evidence of CNS morbidity in the first ten days of life
Routine cranial ultrasound obtained within the first ten days of life will be utilized to detect grade 3 or 4 intraventricular hemorrhage, periventricular leukomalacia, significant ventriculomegaly, or white matter abnormalities.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23973384Verhagen EA, Hummel LA, Bos AF, Kooi EM. Near-infrared spectroscopy to detect absence of cerebrovascular autoregulation in preterm infants. Clin Neurophysiol. 2014 Jan;125(1):47-52. doi: 10.1016/j.clinph.2013.07.001. Epub 2013 Aug 22.
- Background: PubMed 23140883Alderliesten T, Lemmers PM, Smarius JJ, van de Vosse RE, Baerts W, van Bel F. Cerebral oxygenation, extraction, and autoregulation in very preterm infants who develop peri-intraventricular hemorrhage. J Pediatr. 2013 Apr;162(4):698-704.e2. doi: 10.1016/j.jpeds.2012.09.038. Epub 2012 Nov 6.
- Background: PubMed 17515873Soul JS, Hammer PE, Tsuji M, Saul JP, Bassan H, Limperopoulos C, Disalvo DN, Moore M, Akins P, Ringer S, Volpe JJ, Trachtenberg F, du Plessis AJ. Fluctuating pressure-passivity is common in the cerebral circulation of sick premature infants. Pediatr Res. 2007 Apr;61(4):467-73. doi: 10.1203/pdr.0b013e31803237f6.
- Background: PubMed 22905222Wong FY, Silas R, Hew S, Samarasinghe T, Walker AM. Cerebral oxygenation is highly sensitive to blood pressure variability in sick preterm infants. PLoS One. 2012;7(8):e43165. doi: 10.1371/journal.pone.0043165. Epub 2012 Aug 14.
- Background: PubMed 21364491Caicedo A, De Smet D, Naulaers G, Ameye L, Vanderhaegen J, Lemmers P, Van Bel F, Van Huffel S. Cerebral tissue oxygenation and regional oxygen saturation can be used to study cerebral autoregulation in prematurely born infants. Pediatr Res. 2011 Jun;69(6):548-53. doi: 10.1203/PDR.0b013e3182176d85.
- Background: PubMed 18250118Wong FY, Leung TS, Austin T, Wilkinson M, Meek JH, Wyatt JS, Walker AM. Impaired autoregulation in preterm infants identified by using spatially resolved spectroscopy. Pediatrics. 2008 Mar;121(3):e604-11. doi: 10.1542/peds.2007-1487. Epub 2008 Feb 4.
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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.
Valerie Chock, MD principal investigator
Stanford University
Krisa Van Meurs, MD principal investigator
Stanford University
7 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 of Prematurity and Complications of Prematurity, run by Stanford University at 7 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 4 inclusion and 4 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 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Yes. Results are posted in the registry (first posted 7 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mortality Before Hospital Discharge (time frame: Outcome measure will be assessed at the time of subject's initial discharge from the hospital (on average by 40 weeks postmenstrual age), but at a maximum of 1 year of life.). 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?
On the ClinicalTrials.gov record for NCT02147769, which also lists 6 linked publications.
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 7 Apr 2020.