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| Name | Class |
|---|---|
| Norton Healthcare | OTHER |
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Our study will be a prospective observational study of all patients in the Norton Children's Hospital NICU (Neonatal Intensive Care Unit) who undergo a transcatheter PDA occlusion or medical closure of PDA to compare the two populations regarding changes in organ perfusion determined by using NIRS monitoring to follow the regional saturation of oxygen (rSO2) of the cerebral and renal regions. We suspect that medical treatment will have no significant change in rSO2 as described in previous literature. We also suspect that transcatheter occlusion will have minimal effects on rSO2 and be comparable to medical therapy.
Informed Consent will be obtained prior to initiation of the study protocol. NIRS Monitoring (Cerebral and Renal) will be placed with skin probes on the scalp and abdomen up to 24 hours prior to initiation of treatment either through medical therapy (Tylenol or indomethacin) or transcatheter occlusion. These values will be used to create an average baseline for the patient. NIRS will be left on during treatment/procedure and for 5 days after treatment to monitor any changes during or after treatment of the PDA. Changes will be compared to baseline readings.
NIRS monitoring will be done with INOVS 7100 Regional Oximeter from Medtronic (https://www.medtronic.com/covidien/en-us/products/cerebral-somatic-oximetry/invos-7100 system.html). Data collection will be done through chart review and pulling logged data from the NIRS monitoring unit. Data to be collected will include type of treatment, gestational age, patient birth weight, patient weight at time of treatment, and rSO2 (Cerebral and Regional) rSO2 variation will be addressed by calculating Coefficients of Variance at 5min epochs which has been shown to decrease the effects of normal variation.
Standardized time points will be compared between the two groups as follows:
Data to be collected will include type of treatment, gestational age, patient birth weight, patient weight at time of treatment, and rSO2 (Cerebral and Regional)
rSO2 variation will b e addressed by calculating Coefficients of Variance at 5min epochs which has been shown to decrease the effects of normal variation (10).
Standardized time points will be compared between the two groups as follows:
Statistician will analyze data collected
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trancatheter occlusion | Other | Patients who are being treated with transcatheter occlusion for PDA closure are eligible to participate in this study for NIRS monitoring. |
|
| Medical closure | Other | Patients who are being treated with tylenol or indomethacin for medical closure of their PDA are eligible to participate in this study for NIRS monitoring. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIRS monitor | Device | NIRS monitoring data will be collected to determine organ perfusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| Measure changes in rScO2 and SrO2 after TCPC of a PDA and compare to baseline readings. | NIRS cerebral and regional monitoring | Baseline through 48 hours post procedure and daily for 5 days |
| Measure changes in rScO2 and SrO2 after medical closure of PDA with Tylenol. | NIRS cerebral and regional monitoring | Baseline through 48 hours post procedure and daily for 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Compare rates of co-morbid conditions between the two groups such as but not limited to necrotizing enterocolitis, feedings intolerance, or failed to extubate within 5 days post treatment. | Medical outcomes | Baseline through 5 days post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Scott D Duncan, MD | Contact | 502-629-5283 | scottd.duncan@louisville.edu | |
| Sarah P King, BA | Contact | 502-629-5283 | slpenn03@louisville.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norton Children's Hospital | Recruiting | Louisville | Kentucky | 40202 | United States |
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Patients who are being treated for PDA closure either via transcatheter occlusion or medical closure as part of routine care are eligible for this study.
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