Prematurity of FetusNCT01428180
Influence of Treatment for Patent Ductus Arteriosus on Cerebral Oxygenation in Preterm Infants
An observational study of Prematurity of Fetus and Patent Ductus Arteriosus, run by University of Ulm at 1 site in Germany.
Trial summary
The purpose of this study is to examine the influence medical or surgical treatment for patent ductus arteriosus in preterm infants on cerebral and renal tissue oxygenation and on cardiac output. Read more about this study
- Who is it for?
- Ages Up to 34 weeks
- Conditions the study is for
- Prematurity of Fetus, Patent Ductus Arteriosus
- What is being tested?
- Indomethacin, Surgical Ligation and Ibuprofen
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2011to Mar 2016
- 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 Up to 34 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Preterm neonates with patent ductus arteriosus treated in our hospital
Who may be able to join
- Newborn infant below 34 weeks postmenstrual age at the time of birth
- Patent ductus arteriosus with signs of hemodynamic relevance (as judged by the attending neonatologist)
- parental informed consent
Who cannot join
- Patent ductus arteriosus as part of malformation syndrome
- Additional major cardiovascular malformations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes of Cerebral Tissue Oxygen Saturation During Treatment of Patent Ductus Arteriosus in Neonates
The purpose of this study is to examine the influence medical or surgical treatment for patent ductus arteriosus in preterm infants on cerebral and renal tissue oxygenation and on cardiac output.
Read the detailed description
In this observational trial the investigators want to examine whether clinical or echocardiographic parameters of patent ductus arteriosus are related to
- cerebral tissue oxygen saturation, total hemoglobin, fractional tissue oxygen extraction and HbD
- renal tissue oxygen saturation, total hemoglobin, fractional tissue oxygen extraction and HbD as measured by near infrared spectroscopy and to
- stroke volume
- cardiac output as measured by electrical cardiometry.
The investigators want to examine the impact of surgical and medical treatment for patent ductus on these parameters. The investigators want to compare the change of these parameters between responders to medical treatment and nonresponders.
- Conditions
- Prematurity of Fetus, Patent Ductus Arteriosus
- Being tested
- Indomethacin, Surgical Ligation, Ibuprofen
- Keywords
- preterm neonates, hemodynamically relevant patent ductus arteriosus
- 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.
IndomethacinDrug
3 doses of 0,2mg/kg every 12h (first week of life) or every 8h (after first week of life)
Surgical LigationProcedure or surgery
In nonresponders to medical treatment with persistent hemodynamically relevant patent ductus arteriosus surgical ligation is performed.
IbuprofenDrug
3 doses every 24h; first dose 10mg/kg, second and third dose 5mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Indomethacin | Infants treated with Indomethacin Receives: Drug: Indomethacin | |
| Ibuprofen | Infants treated with Ibuprofen Receives: Drug: Ibuprofen | |
| Ligation | Infants undergoing surgical ligation Receives: Procedure: Surgical Ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of cerebral tissue oxygen saturation during treatment for patent ductus arteriosus
Measured: from 10 minutes before start of infusion until 4 hours after end of transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2011 (estimated)
- Study startApr 2011
- Primary completionOct 2012
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prematurity of FetusStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Schmid, University of Ulm
- Investigators
- Manuel B Schmid, Dr. med., Principal investigator, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01428180
- Sponsor's protocol ID
- ULMNEONIRS03
- Status last verified
- Apr 2016
- First submitted
- 31 Aug 2011
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Cerebral Tissue Oxygen Saturation During Treatment of Patent Ductus Arteriosus in Neonates
- ClinicalTrials.gov ID
- NCT01428180
- Acronym / sponsor ID
- ULMNEONIRS03
- Conditions
- Prematurity of Fetus, Patent Ductus Arteriosus
- Keywords
- preterm neonates, hemodynamically relevant patent ductus arteriosus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 2 Sep 2011 (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 examine the influence medical or surgical treatment for patent ductus arteriosus in preterm infants on cerebral and renal tissue oxygenation and on cardiac output.
Detailed description
In this observational trial the investigators want to examine whether clinical or echocardiographic parameters of patent ductus arteriosus are related to
- cerebral tissue oxygen saturation, total hemoglobin, fractional tissue oxygen extraction and HbD
- renal tissue oxygen saturation, total hemoglobin, fractional tissue oxygen extraction and HbD as measured by near infrared spectroscopy and to
- stroke volume
- cardiac output as measured by electrical cardiometry.
The investigators want to examine the impact of surgical and medical treatment for patent ductus on these parameters. The investigators want to compare the change of these parameters between responders to medical treatment and nonresponders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Indomethacin | – | Drug: IndomethacinInfants treated with Indomethacin |
| Ibuprofen | – | Drug: IbuprofenInfants treated with Ibuprofen |
| Ligation | – | Procedure: Surgical LigationInfants undergoing surgical ligation |
Who may qualify
- Ages
- Up to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm neonates with patent ductus arteriosus treated in our hospital
Key inclusion criteria (3 listed)
- Newborn infant below 34 weeks postmenstrual age at the time of birth
- Patent ductus arteriosus with signs of hemodynamic relevance (as judged by the attending neonatologist)
- parental informed consent
Key exclusion criteria (2 listed)
- Patent ductus arteriosus as part of malformation syndrome
- Additional major cardiovascular malformations
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 |
|---|---|---|
| Indomethacin3 doses of 0,2mg/kg every 12h (first week of life) or every 8h (after first week of life) | Drug | Indomethacin |
| Surgical LigationIn nonresponders to medical treatment with persistent hemodynamically relevant patent ductus arteriosus surgical ligation is performed. | Procedure or surgery | Ligation |
| Ibuprofen3 doses every 24h; first dose 10mg/kg, second and third dose 5mg/kg | Drug | Ibuprofen |
Primary outcome
Change of cerebral tissue oxygen saturation during treatment for patent ductus arteriosus
Time frame: from 10 minutes before start of infusion until 4 hours after end of transfusion
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 6 Apr 2016.
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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.
Manuel B Schmid, Dr. med. principal investigator
University of Ulm
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 Prematurity of Fetus and Patent Ductus Arteriosus, run by University of Ulm at 1 site in Germany.
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 3 inclusion and 2 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 6 Apr 2016. 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 Germany. 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.
What does the primary outcome measure?
Change of cerebral tissue oxygen saturation during treatment for patent ductus arteriosus (time frame: from 10 minutes before start of infusion until 4 hours after end of transfusion). 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 6 Apr 2016.