Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06359522
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-03-11
Brief Title:
PDA Occlusion Using NIRS
Sponsor:
University of Louisville
Organization:
University of Louisville
Study Overview
Official Title:
A Comparative Study of Medical Management vs Transcatheter PDA Occlusion Using Near-Infrared Spectroscopy
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Our study will be a prospective observational study of all patients in the Norton Childrens 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
Detailed Description:
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 treatmentprocedure 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 httpswwwmedtroniccomcovidienen-usproductscerebral-somatic-oximetryinvos-7100 systemhtml 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
1 Baseline Levels 24 hours prior to treatment
2 During the Procedure during initiation of procedure 5min after device placed10 min post device placement 30min post device placement and 1 hour post placement
3 Levels at 12 hours post treatment until 48 hours post and then daily until monitoring is discontinued
4 Arterial O2 Saturations FiO2 mode of ventilation will be recorded at the above time points as well and fractionated
Statistician will analyze data collected
NIRS monitoring will be done with INOVS 7100 Regional Oximeter from Medtronic httpswwwmedtroniccomcovidienen-usproductscerebral-somatic-oximetryinvos-7100 systemhtml 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
1 Baseline Levels 24 hours prior to treatment
2 During the Procedure during initiation of procedure 5min after device placed10 min post device placement 30min post device placement and 1 hour post placement
3 Levels at 12 hours post treatment until 48 hours post and then daily until monitoring is discontinued
4 Arterial O2 Saturations FiO2 mode of ventilation will be recorded at the above time points as well and fractionated
Statistician will analyze data collected
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None