Organ Perfusion Determined by Using NIRS Post Transcatheter PDA Occlusion or Medical Closure of PDANCT06359522
PDA Occlusion Using NIRS
A study testing NIRS monitor in people with Organ Perfusion Determined by Using NIRS Post Transcatheter PDA Occlusion or Medical Closure of PDA, run by University of Louisville at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 0 to 3 months
- Conditions the study is for
- Organ Perfusion Determined by Using NIRS Post Transcatheter PDA Occlusion or Medical Closure of PDA
- What is being tested?
- NIRS monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2023to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants in the Norton Children's NICU with hsPDA deemed to require closure either through medical therapy or transcatheter occlusion by the primary NICU care team.
- Parents or Legal Guardian provide written consent for the infant to participate in this study
Who cannot join
- Infants with other hemodynamically significant congenital heart disease that could affect systemic blood flow
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Norton Children's Hospital
Louisville, Kentucky, 40202
Scott D Duncan, MD, 502-629-5283, scottd.duncan@louisville.edu
Janice E. Sullivan, MD, 502-629-5283, sully@louisville.edu
About this study
Official title: A Comparative Study of Medical Management vs Transcatheter PDA Occlusion Using Near-Infrared Spectroscopy
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.
Read the 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 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:
- Baseline Levels: 24 hours prior to treatment
- During the Procedure: during initiation of procedure, 5min after device placed,10 min post device placement, 30min post device placement and 1 hour post placement
- Levels at 12 hours post treatment, until 48 hours post and then daily until monitoring is discontinued.
- Arterial O2 Saturations, FiO2 %, mode of ventilation will be recorded at the above time points as well and fractionated
- Statistician will analyze data collected
- Conditions
- Organ Perfusion Determined by Using NIRS Post Transcatheter PDA Occlusion or Medical Closure of PDA
- Being tested
- NIRS monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRS monitorDevice
NIRS monitoring data will be collected to determine organ perfusion.
| Study group | Role | What they receive |
|---|---|---|
| Trancatheter occlusion | Other | Patients who are being treated with transcatheter occlusion for PDA closure are eligible to participate in this study for NIRS monitoring. Receives: Device: NIRS monitor |
| 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. Receives: Device: NIRS monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure changes in rScO2 and SrO2 after TCPC of a PDA and compare to baseline readings.
NIRS cerebral and regional monitoring
Measured: 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
Measured: Baseline through 48 hours post procedure and daily for 5 days
Secondary outcomes (1)
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
Measured: Baseline through 5 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start18 Apr 2023
- Primary completion31 Mar 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organ Perfusion Determined by Using NIRS Post Transcatheter PDA Occlusion or Medical Closure of PDAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- Norton Healthcare
- Responsible party
- Principal investigator, Scott Duncan, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359522
- Sponsor's protocol ID
- 22.0334
- Status last verified
- Apr 2024
- First submitted
- 11 Mar 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Medical Management vs Transcatheter PDA Occlusion Using Near-Infrared Spectroscopy
- ClinicalTrials.gov ID
- NCT06359522
- Acronym / sponsor ID
- 22.0334
- Conditions
- Organ Perfusion Determined by Using NIRS Post Transcatheter PDA Occlusion or Medical Closure of PDA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- Norton Healthcare
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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:
- Baseline Levels: 24 hours prior to treatment
- During the Procedure: during initiation of procedure, 5min after device placed,10 min post device placement, 30min post device placement and 1 hour post placement
- Levels at 12 hours post treatment, until 48 hours post and then daily until monitoring is discontinued.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Trancatheter occlusion | Other | Device: NIRS monitorPatients who are being treated with transcatheter occlusion for PDA closure are eligible to participate in this study for NIRS monitoring. |
| Medical closure | Other | Device: NIRS monitorPatients who are being treated with tylenol or indomethacin for medical closure of their PDA are eligible to participate in this study for NIRS monitoring. |
Who may qualify
- Ages
- 0 to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants in the Norton Children's NICU with hsPDA deemed to require closure either through medical therapy or transcatheter occlusion by the primary NICU care team.
- Parents or Legal Guardian provide written consent for the infant to participate in this study
Key exclusion criteria (1 listed)
- Infants with other hemodynamically significant congenital heart disease that could affect systemic blood flow
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIRS monitorNIRS monitoring data will be collected to determine organ perfusion. | Device | Medical closure, Trancatheter occlusion |
Primary outcome
Measure changes in rScO2 and SrO2 after TCPC of a PDA and compare to baseline readings.
Time frame: Baseline through 48 hours post procedure and daily for 5 days
NIRS cerebral and regional monitoring
Measure changes in rScO2 and SrO2 after medical closure of PDA with Tylenol.
Time frame: Baseline through 48 hours post procedure and daily for 5 days
NIRS cerebral and regional monitoring
1 secondary outcome
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.
Time frame: Baseline through 5 days post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIRS monitor in people with Organ Perfusion Determined by Using NIRS Post Transcatheter PDA Occlusion or Medical Closure of PDA, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Scott D Duncan, MD (502-629-5283, scottd.duncan@louisville.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure changes in rScO2 and SrO2 after TCPC of a PDA and compare to baseline readings. (time frame: Baseline through 48 hours post procedure and daily for 5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.