Ductus Arteriosus, PatentNCT01251939
Changes in Renal and Splanchnic Oxygenation During Ibuprofen Treatment for Patent Ductus Arterious
An observational study of Ductus Arteriosus, Patent, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Patent ductus arterious(PDA)is frequently seen and potentially pathologic in preterm infants. Near-infrared spectroscopy is a simple bedside tool to analyse the changes in the renal and splanchnic tissue oxygenation index and fractional tissue oxygen extraction and may be helpful to measure effects of ibuprofen… Read more about this study
- Who is it for?
- Ages 2 days and older
- Conditions the study is for
- Ductus Arteriosus, Patent
- What is being tested?
- Near-infrared spectroscopy (NIRS)
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2011to Aug 2012
- 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 2 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All infants who born in Zekai Tahir Burak Maternity and Teaching Hospital between january 2011 and january 2012 and met the entry criteria first underwent echocardiography and cranial ultrasonography.
Who may be able to join
- Gestational age <32 weeks and <1500 g
- Echocardiographic evidence of hemodynamically significant patent ductus arterious
Who cannot join
- Major congenital anomalies
- Intraventricular hemorrhage of grade 3 within the previous 24 hours
- Serum creatinine level 1.5 mg%,serum urea nitrogen concentration >50 mg%,
- Platelet count 60 000/mL3, a tendency to bleed (defined by the presence of hematuria, blood in the endotracheal aspirate, gastric aspirate, or stools and/or oozing from puncture sites)
- Hyperbilirubinemia necessitating exchange transfusion
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zekai Tahir Burak Maternity and Teaching Hospital
Ankara
About this study
Official title: Observational Study of Near Infrared Spectroscopy to Monitor Renal and Splanchnic Oxygenation During Ibuprofen Treatment for Patent Ductus Arterious in Preterm Infants
Patent ductus arterious(PDA)is frequently seen and potentially pathologic in preterm infants. Near-infrared spectroscopy is a simple bedside tool to analyse the changes in the renal and splanchnic tissue oxygenation index and fractional tissue oxygen extraction and may be helpful to measure effects of ibuprofen treatment for PDA in preterm infants.
Read the detailed description
Patent ductus arterious (PDA) is the most common cardiovascular abnormality in preterm infants.There are clear associations between a PDA and decreased renal and splanchnic blood flow. The aim is to monitor, using near-infrared spectroscopy, the effect of ibuprofen on the fractional tissue (renal and mesenteric) oxygen extraction (FTOE) in preterm newborns during ibuprofen of the treatment PDA.
- Conditions
- Ductus Arteriosus, Patent
- Being tested
- Near-infrared spectroscopy (NIRS)
- 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.
Near-infrared spectroscopy (NIRS)Device
Also called INVOS 4100 oximeter, Somanetics,
Non-invasive monitoring device measures the quantity of reflected light photons as a function of two wavelengths, and determines the spectral absorption of the underlying tissue.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with ibuprofen | Gestational age <32 weeks and <1500 g, postnatal age older than 48 hours and echocardiographic evidence of hemodynamically significant PDA Receives: Device: Near-infrared spectroscopy (NIRS) | |
| Controls | Gestational age <32 weeks and <1500 g, postnatal age older than 48 hours and without significant PDA Receives: Device: Near-infrared spectroscopy (NIRS) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2010 (estimated)
- Study startOct 2011
- Primary completionJul 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ductus Arteriosus, PatentStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilufer Guzoglu, Zekai Tahir Burak Women's Health Research and Education Hospital
- Investigators
- Nilufer Guzoglu, Principal investigator, Zekai Tahir Burak Women's Health Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01251939
- Sponsor's protocol ID
- n7860088
- Status last verified
- Aug 2012
- First submitted
- 29 Nov 2010
- Last updated
- 21 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Near Infrared Spectroscopy to Monitor Renal and Splanchnic Oxygenation During Ibuprofen Treatment for Patent Ductus Arterious in Preterm Infants
- ClinicalTrials.gov ID
- NCT01251939
- Acronym / sponsor ID
- n7860088
- Conditions
- Ductus Arteriosus, Patent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 2 Dec 2010 (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.
Patent ductus arterious(PDA)is frequently seen and potentially pathologic in preterm infants. Near-infrared spectroscopy is a simple bedside tool to analyse the changes in the renal and splanchnic tissue oxygenation index and fractional tissue oxygen extraction and may be helpful to measure effects of ibuprofen treatment for PDA in preterm infants.
Detailed description
Patent ductus arterious (PDA) is the most common cardiovascular abnormality in preterm infants.There are clear associations between a PDA and decreased renal and splanchnic blood flow. The aim is to monitor, using near-infrared spectroscopy, the effect of ibuprofen on the fractional tissue (renal and mesenteric) oxygen extraction (FTOE) in preterm newborns during ibuprofen of the treatment PDA.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with ibuprofen | – | Device: Near-infrared spectroscopy (NIRS)Gestational age <32 weeks and <1500 g, postnatal age older than 48 hours and echocardiographic evidence of hemodynamically significant PDA |
| Controls | – | Device: Near-infrared spectroscopy (NIRS)Gestational age <32 weeks and <1500 g, postnatal age older than 48 hours and without significant PDA |
Who may qualify
- Ages
- 2 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All infants who born in Zekai Tahir Burak Maternity and Teaching Hospital between january 2011 and january 2012 and met the entry criteria first underwent echocardiography and cranial ultrasonography.
Key inclusion criteria (2 listed)
- Gestational age <32 weeks and <1500 g
- Echocardiographic evidence of hemodynamically significant patent ductus arterious
Key exclusion criteria (5 listed)
- Major congenital anomalies
- Intraventricular hemorrhage of grade 3 within the previous 24 hours
- Serum creatinine level 1.5 mg%,serum urea nitrogen concentration >50 mg%,
- Platelet count 60 000/mL3, a tendency to bleed (defined by the presence of hematuria, blood in the endotracheal aspirate, gastric aspirate, or stools and/or oozing from puncture sites)
- Hyperbilirubinemia necessitating exchange transfusion
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 |
|---|---|---|
| Near-infrared spectroscopy (NIRS)Also: INVOS 4100 oximeter, Somanetics,Non-invasive monitoring device measures the quantity of reflected light photons as a function of two wavelengths, and determines the spectral absorption of the underlying tissue. | Device | Controls, Treatment with ibuprofen |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2012.
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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.
Nilufer Guzoglu principal investigator
Zekai Tahir Burak Women's Health Research and Education Hospital
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 Ductus Arteriosus, Patent, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
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 5 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: finished, as of the sponsor's last update on 21 Aug 2012. 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 Turkey (Türkiye). 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 21 Aug 2012.