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| Name | Class |
|---|---|
| Boston Children's Hospital | OTHER |
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The proposed research evaluates tissue oxygenation (StO2) as measured by resonance raman spectroscopy (RRS) in premature infants with and without patent ductus arteriosus (PDA). This is a prospective observational study of infants born at < 30 weeks of gestation. The primary aim of this study is to determine if the difference in pre- and post-ductal StO2 as detected by RRS is more significant in premature infants with PDA in comparison to infants without PDA. The secondary aim of this study is to determine if the difference in pre- and post-ductal StO2 as detected by RRS is more significant in infant who develop serious adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group -Patent Ductus Arteriosus Absent |
| ||
| Study Group - Patent Ductus Arteriosus Present |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resonance Raman Spectroscopy (RRS) | Device | Pre and post-ductal RRS measurements will be obtained daily for a maximum of 14 data collection times in infants with and without PDAs. |
| Measure | Description | Time Frame |
|---|---|---|
| Differences and pre- and post-ductal RRS measurements of tissue oxygenation. | Pre- and post-ductal tissues oxygenation as measured by RRS may be more significant in infants with PDA. | Up to a maximum of 14 data collection times |
| Measure | Description | Time Frame |
|---|---|---|
| Are differences in pre- and post-ductal StO2 as detected by RRS more significant in infants with serious adverse events. | RRS measurements and the difference between pre- and post-ductal tissue oxygenation will be evaluated in infants with serious adverse events to determine if the measurements could have predicted the serious adverse event. | Up to a maximum of 14 data collection times |
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Inclusion Criteria:
Exclusion Criteria:
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Premature infants born <30 weeks gestational age and admitted to the Boston Children's Hospital neonatal intensive care unit (NICU), Brigham and Women's NICU, and the University of Florida NICU.
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| Name | Affiliation | Role |
|---|---|---|
| J Lauren Ruoss, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States | ||
| Boston Children's Hospital |
The analysis of the data will be shared with other research. Individual patient data will not be shared.
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D004374 | Ductus Arteriosus, Patent |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Boston |
| Massachusetts |
| 02115 |
| United States |
| D000091642 | Urogenital Diseases |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |