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Near-infrared spectroscopy (NIRS), is a technology that can provide continuous, non-invasive monitoring of oxygenation in tissue. The objective of this study is to obtain the cerebral regional oxygen saturation (cRSO2) in a preterm population that is born at altitude to determine if the range of "normal" values is different than those obtained at sea level.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational Arm | Experimental | Any infant consented to participate in the study will have the NIRS applied for the first 96 hours of life. It will be the goal to apply the NIRS sensors in the first 12 hours of life. All infants will have the same treatment if in the study, but clinicians will not be able to see the data obtained so that there is no clinical interpretation during this time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Near-infrared spectroscopy (NIRS) utilization | Device | The NIRS devise will be applied so that cerebral regional oxygen saturation (cRSO2) can be measured. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral Regional Oxygen Saturation (cRSO2) | Measure cRSO2 for the first 96 hours of life in infants born preterm. | first 96 hours of life |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Major Complications of Prematurity | Additional items recorded to determine if there is any correlation with the cRSO2 values, including death, intraventricular hemorrhage, necrotizing enterocolitis, sepsis, duration of supplemental oxygen required, time to taking full volume feeds via nippling, and hospital length of stay. | From birth until the end of the birth hospitalization, which would be discharge home or death, whichever occurs first. Estimated time is up to 6 months of age. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico | Albuquerque | New Mexico | 87131 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Observational Arm | Any infant consented to participate in the study will have the NIRS applied for the first 96 hours of life. It will be the goal to apply the NIRS sensors in the first 12 hours of life. All infants will have the same treatment if in the study, but clinicians will not be able to see the data obtained so that there is no clinical interpretation during this time. Near-infrared spectroscopy (NIRS) utilization: The NIRS devise will be applied so that cerebral regional oxygen saturation (cRSO2) can be measured. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Observational Arm | Any infant consented to participate in the study will have the NIRS applied for the first 96 hours of life. It will be the goal to apply the NIRS sensors in the first 12 hours of life. All infants will have the same treatment if in the study, but clinicians will not be able to see the data obtained so that there is no clinical interpretation during this time. Near-infrared spectroscopy (NIRS) utilization: The NIRS devise will be applied so that cerebral regional oxygen saturation (cRSO2) can be measured. |
| 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 | Cerebral Regional Oxygen Saturation (cRSO2) | Measure cRSO2 for the first 96 hours of life in infants born preterm. | Posted | Mean | Full Range | percent rcSO2 | first 96 hours of life |
|
birth until discharge from birth hospitalization (up to 1 year of age)
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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 | Observational Arm | Any infant consented to participate in the study will have the NIRS applied for the first 96 hours of life. It will be the goal to apply the NIRS sensors in the first 12 hours of life. All infants will have the same treatment if in the study, but clinicians will not be able to see the data obtained so that there is no clinical interpretation during this time. Near-infrared spectroscopy (NIRS) utilization: The NIRS devise will be applied so that cerebral regional oxygen saturation (cRSO2) can be measured. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intraventricular hemorrhage | Nervous system disorders | Non-systematic Assessment | IVH grade I-IV |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessie Maxwell, MD, MBA | University of New Mexico | 505-272-3967 | JRMaxwell@salud.unm.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 | May 26, 2021 | Jan 14, 2024 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 28, 2020 | Nov 28, 2020 | ICF_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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| ID | Term |
|---|---|
| D019265 | Spectroscopy, Near-Infrared |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013057 | Spectrum Analysis |
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The study will be a prospective observational study, in which any infant consented to participate in the study will have the NIRS applied for the first 96 hours of life.
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| Participants |
|
| Age, Continuous | Mean | Full Range | weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| rcSO2 (cerebral regional oxygen saturation) | Mean | Inter-Quartile Range | % of rcSO2 |
|
| CRIB-II (Clinical Risk Index for Babies) II Scoring System | CRIB II (clinical risk index for babies, version 2) is a scoring system in prediction of mortality in premature babies (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4525567/). The score range is 0 to 27, with a better prognosis with lower scores attained. | Median | Inter-Quartile Range | score |
|
| cFTOE (cerebral fractional tissue oxygen extraction) | Median | Inter-Quartile Range | % of cFTOE |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Incidence of Major Complications of Prematurity | Additional items recorded to determine if there is any correlation with the cRSO2 values, including death, intraventricular hemorrhage, necrotizing enterocolitis, sepsis, duration of supplemental oxygen required, time to taking full volume feeds via nippling, and hospital length of stay. | Infants with complications of prematurity | Posted | Number | number of infant with condition | From birth until the end of the birth hospitalization, which would be discharge home or death, whichever occurs first. Estimated time is up to 6 months of age. |
|
|
|
| 1 |
| 21 |
| 19 |
| 21 |
| 0 |
| 21 |
|
| Retinopathy of Prematurity | Eye disorders | Non-systematic Assessment | ROP requiring treatment |
|
| Necrotizing enterocolitis | Gastrointestinal disorders | Non-systematic Assessment | Infants diagnosed with NEC |
|
| Late onset sepsis | Immune system disorders | Non-systematic Assessment | Infants diagnosed with late onset sepsis |
|
| Patent Ductus Arteriosus | Cardiac disorders | Non-systematic Assessment | Infants with PDA who required treatment |
|
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| D000091642 | Urogenital Diseases |
| D002623 |
| Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |