Patent Ductus ArteriosusNCT00554307
Brain, Gut and Kidney Blood Flow During Medical Closure of PDA
An observational study of Patent Ductus Arteriosus, run by University of Louisville at 1 site in United States.
Trial summary
The purpose of this study is to determine how the medications which are used to close the patent ductus arteriosus (PDA) in preterm infants affect brain, kidney and gut blood flow when compared to infants that are not treated with these medications. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patent Ductus Arteriosus
- What is being tested?
- INVOS Cerebral/Somatic oximeter
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Dec 2009
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Preterm infants with patent ductus arteriosus requiring medical intervention
Who may be able to join
- Less than or equal to 32 weeks gestation;
- Less than or equal to 1250 g;
- Mechanical ventilation;
- Echocardiographic findings of PDA with left to right shunting;
- Medical judgement of neonatologist for medical treatment;
Who cannot join
- Urine output less than 1 ml/k/hr over previous 12 hours;
- Serum creatinine greater than 1.5 mg/dL;
- Platelet count less than 100,000 per cubic mm;
- Significant skin breakdown at sensor areas;
- Significant congenital anomalies
- Intraventricular hemorrhage greater than or equal to grade III
Trial locations and contacts
1 site in 1 country.
United States1 site
Kosair Children's Hospital
Lousiville, Kentucky, 40202
About this study
Official title: Comparison of Cerebral, Renal and Mesenteric Perfusion Using Near Infrared Spectroscopy in Neonates During Patent Ductus Arteriosus Closure With Ibuprofen or Indomethacin.
The purpose of this study is to determine how the medications which are used to close the patent ductus arteriosus (PDA) in preterm infants affect brain, kidney and gut blood flow when compared to infants that are not treated with these medications. The medications being used for PDA closure are indomethacin and neoprofen.
Read the detailed description
All babies requiring medical treatment of their PDA will receive up to 3 doses of medication. For babies enrolled in the control group of this study, she/he will not be treated with either of these medicines.
- Conditions
- Patent Ductus Arteriosus
- Being tested
- INVOS Cerebral/Somatic oximeter
- Keywords
- patent ductus arteriosus, indomethacin, neoprofen, blood flow
- Medical subject headings
- Ductus Arteriosus, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INVOS Cerebral/Somatic oximeterDevice
Placement of sensors on back, abdomen and forehead for measurement of perfusion beginning 1 hour prior to initiation of drug, during medical treatment for PDA and for 24 hours after the last dose. For control infants, monitoring will continue for 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| Indo | Infants that are treated with indomethacin Receives: Device: INVOS Cerebral/Somatic oximeter | |
| Neo | Infants treated with neoprofen Receives: Device: INVOS Cerebral/Somatic oximeter | |
| Control | Infants without PDA Receives: Device: INVOS Cerebral/Somatic oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in blood flow from baseline in infants treated with indomethacin or neoprofen. Blood flow will be measured in the brain, kidney and mesentery.
Measured: 48-72 hours
Measure oxygenation/blood flow to brain during PDA treatment
Measured: Study period
Secondary outcomes (1)
Oxygenation during/after treatment with PDA therapy
Measured: Study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionDec 2009
- Study completionDec 2009
Why it stopped: Not able to enroll patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patent Ductus ArteriosusStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- H. Lundbeck A/S
- Investigators
- Dan L Stewart, MD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00554307
- Sponsor's protocol ID
- UofL IRB 328.07
- Status last verified
- Jan 2015
- First submitted
- 2 Nov 2007
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cerebral, Renal and Mesenteric Perfusion Using Near Infrared Spectroscopy in Neonates During Patent Ductus Arteriosus Closure With Ibuprofen or Indomethacin.
- ClinicalTrials.gov ID
- NCT00554307
- Acronym / sponsor ID
- UofL IRB 328.07
- Conditions
- Patent Ductus Arteriosus
- Keywords
- patent ductus arteriosus, indomethacin, neoprofen, blood flow
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Not able to enroll patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- H. Lundbeck A/S
- Study start
- Nov 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 6 Nov 2007 (estimated)
- 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.
The purpose of this study is to determine how the medications which are used to close the patent ductus arteriosus (PDA) in preterm infants affect brain, kidney and gut blood flow when compared to infants that are not treated with these medications. The medications being used for PDA closure are indomethacin and neoprofen.
Detailed description
All babies requiring medical treatment of their PDA will receive up to 3 doses of medication. For babies enrolled in the control group of this study, she/he will not be treated with either of these medicines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Indo | – | Device: INVOS Cerebral/Somatic oximeterInfants that are treated with indomethacin |
| Neo | – | Device: INVOS Cerebral/Somatic oximeterInfants treated with neoprofen |
| Control | – | Device: INVOS Cerebral/Somatic oximeterInfants without PDA |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Preterm infants with patent ductus arteriosus requiring medical intervention
Key inclusion criteria (5 listed)
- Less than or equal to 32 weeks gestation;
- Less than or equal to 1250 g;
- Mechanical ventilation;
- Echocardiographic findings of PDA with left to right shunting;
- Medical judgement of neonatologist for medical treatment;
Key exclusion criteria (6 listed)
- Urine output less than 1 ml/k/hr over previous 12 hours;
- Serum creatinine greater than 1.5 mg/dL;
- Platelet count less than 100,000 per cubic mm;
- Significant skin breakdown at sensor areas;
- Significant congenital anomalies
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 |
|---|---|---|
| INVOS Cerebral/Somatic oximeterPlacement of sensors on back, abdomen and forehead for measurement of perfusion beginning 1 hour prior to initiation of drug, during medical treatment for PDA and for 24 hours after the last dose. For control infants, monitoring will continue for 48 hours. | Device | Control, Indo, Neo |
Primary outcome
Changes in blood flow from baseline in infants treated with indomethacin or neoprofen. Blood flow will be measured in the brain, kidney and mesentery.
Time frame: 48-72 hours
Measure oxygenation/blood flow to brain during PDA treatment
Time frame: Study period
1 secondary outcome
Oxygenation during/after treatment with PDA therapy
Time frame: Study period
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
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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.
Dan L Stewart, MD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patent Ductus Arteriosus, 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 5 inclusion and 6 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: withdrawn, as of the sponsor's last update on 26 Jan 2015. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in blood flow from baseline in infants treated with indomethacin or neoprofen. Blood flow will be measured in the brain, kidney and mesentery. (time frame: 48-72 hours). 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 26 Jan 2015.