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| Name | Class |
|---|---|
| Medtronic - MITG | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIRS monitoring | Device | All enrolled infants will undergo NIRS monitoring of cerebral oxygenation in addition to monitoring of continuous arterial blood pressure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality Before Hospital Discharge | Participants will be followed for the outcome of death prior to hospital discharge. | 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Valerie Chock, MD | Stanford University | Principal Investigator |
| Krisa Van Meurs, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35249 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23973384 | Background | 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. | |
| 23140883 | Background | Alderliesten 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. NIRS monitoring: All enrolled infants will undergo NIRS monitoring of cerebral oxygenation in addition to monitoring of continuous arterial blood pressure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. NIRS monitoring: All enrolled infants will undergo NIRS monitoring of cerebral oxygenation in addition to monitoring of continuous arterial blood pressure. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mortality Before Hospital Discharge | Participants will be followed for the outcome of death prior to hospital discharge. | Posted | Count of Participants | Participants | 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. |
|
Adverse events were collected until hospital discharge or 6 months (whichever occurred first).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. NIRS monitoring: All enrolled infants will undergo NIRS monitoring of cerebral oxygenation in addition to monitoring of continuous arterial blood pressure. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CNS abnormality | Nervous system disorders | Non-systematic Assessment | Neuroradiographic abnormality on cranial ultrasound |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Valerie Chock, MD | Stanford University | 650-723-5711 | vchock@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 18, 2016 | Apr 5, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Palo Alto |
| California |
| 94304 |
| United States |
| Santa Clara Valley Medical Center | San Jose | California | 95128 | United States |
| Yale-New Haven Children's Hospital | New Haven | Connecticut | 06520 | United States |
| St. John's Children's Hospital | Springfield | Illinois | 62702 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| 17515873 | Background | Soul 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. |
| 22905222 | Background | Wong 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. |
| 21364491 | Background | Caicedo 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. |
| 18250118 | Background | Wong 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. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | weeks gestational age |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Death or Neuroradiographic abnormality at baseline | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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. | Posted | Count of Participants | Participants | 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 |
|
|
|
| 11 |
| 111 |
| 14 |
| 111 |
| 0 |
| 111 |
|
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| D000091642 | Urogenital Diseases |