Closure of the Foramen Ovale and Ductus ArteriosusNCT01032785
Timing of Closure of Patent Foramen Ovale Following Birth
An observational study of Closure of the Foramen Ovale and Ductus Arteriosus, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
It is known that the foramen ovale closes in most infants during the first 6 months of life, however, most of the important papers in the field concentrated on observing infants with murmurs and following those with patent foramen ovale by echocardiography until 6-24 months. Read more about this study
- Who is it for?
- Ages 30 minutes to 4 hoursHealthy volunteers can take part
- Conditions the study is for
- Closure of the Foramen Ovale and Ductus Arteriosus
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2009to Mar 2010
- 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 30 minutes to 4 hours
- All sexes
- Healthy volunteers accepted
- Child
Study population: Population consits of newborn babies born in term and under normal delivery in Wolfson M.C.
Who may be able to join
- any baby born in term and with normal delivery
Who cannot join
- sick newborns in need of neonatal intensive care for any medical reason.
- newborns with congenital heart disease except for small, muscular ventricular septal defects
Trial locations and contacts
1 site in 1 country.
Akiva Tamir, M.D. contact
About this study
Official title: Timing of Closure of Patent Foramen Ovale and Patent Ductus Arteriosus Following Birth
It is known that the foramen ovale closes in most infants during the first 6 months of life, however, most of the important papers in the field concentrated on observing infants with murmurs and following those with patent foramen ovale by echocardiography until 6-24 months. The purpose of this study is to observe the natural profile of closure of the foramen ovale and ductus arteriosus for the first 36 hours after birth. This understanding may help to avoid unnecessary treatment and exams for newborns with findings that are natural for their stage of development.
Read the detailed description
We will observe the patency and size of foramen ovale five times within the first 36 hours of life. We will also describe the anatomy of the foramen ovale and the septum primum during this time. The direction of flow across the foramen ovale will also be observed. Other cardiac lesions will be checked for as well. We will measure the change in size of the pulmonary arteries and the closure of the ductus arteriosus.
- Being tested
- no interventions
- Keywords
- Patent Foramen Ovale, Patent Ductus Arteriosus, PFO, PDA
- Medical subject headings
- Ductus Arteriosus, Patent, Foramen Ovale, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionsDevice
no interventions
| Study group | Role | What they receive |
|---|---|---|
| Healthy term newborn | Any healthy term newborn born in Wolfson Medical Center Receives: Device: no interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patent Foramen Ovale size using 2 echocardiography positions, shunt direction and distance of septum primum to Superior Vena Cava
Measured: 2-3 hours after birth, 5-6 hours, 7-8 hours, 12-13 hours and 36 hours
Secondary outcomes (1)
Patent Ductus Arteriosus size, shunt direction and the size of the Left Pulmonary Artery, the Right Pulmonary Artery and the Pulmonary Annulus
Measured: 2-3 hours after birth, 5-6 hours, 7-8 hours, 12-13 hours, 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionMar 2010 (estimated)
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Closure of the Foramen Ovale and Ductus ArteriosusStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Investigators
- Akiva Tamir, M.D, Principal investigator, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032785
- Sponsor's protocol ID
- 0049-09-WOMC
- Status last verified
- Sep 2010
- First submitted
- 15 Dec 2009
- Last updated
- 14 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Closure of Patent Foramen Ovale and Patent Ductus Arteriosus Following Birth
- ClinicalTrials.gov ID
- NCT01032785
- Acronym / sponsor ID
- 0049-09-WOMC
- Keywords
- Patent Foramen Ovale, Patent Ductus Arteriosus, PFO, PDA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- Dec 2009
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 16 Dec 2009 (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.
It is known that the foramen ovale closes in most infants during the first 6 months of life, however, most of the important papers in the field concentrated on observing infants with murmurs and following those with patent foramen ovale by echocardiography until 6-24 months. The purpose of this study is to observe the natural profile of closure of the foramen ovale and ductus arteriosus for the first 36 hours after birth. This understanding may help to avoid unnecessary treatment and exams for newborns with findings that are natural for their stage of development.
Detailed description
We will observe the patency and size of foramen ovale five times within the first 36 hours of life. We will also describe the anatomy of the foramen ovale and the septum primum during this time. The direction of flow across the foramen ovale will also be observed. Other cardiac lesions will be checked for as well. We will measure the change in size of the pulmonary arteries and the closure of the ductus arteriosus.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy term newborn | – | Device: no interventionsAny healthy term newborn born in Wolfson Medical Center |
Who may qualify
- Ages
- 30 minutes to 4 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Population consits of newborn babies born in term and under normal delivery in Wolfson M.C.
Key inclusion criteria (1 listed)
- any baby born in term and with normal delivery
Key exclusion criteria (2 listed)
- sick newborns in need of neonatal intensive care for any medical reason.
- newborns with congenital heart disease except for small, muscular ventricular septal defects
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 |
|---|---|---|
| no interventionsno interventions | Device | Healthy term newborn |
Primary outcome
Patent Foramen Ovale size using 2 echocardiography positions, shunt direction and distance of septum primum to Superior Vena Cava
Time frame: 2-3 hours after birth, 5-6 hours, 7-8 hours, 12-13 hours and 36 hours
1 secondary outcome
Patent Ductus Arteriosus size, shunt direction and the size of the Left Pulmonary Artery, the Right Pulmonary Artery and the Pulmonary Annulus
Time frame: 2-3 hours after birth, 5-6 hours, 7-8 hours, 12-13 hours, 36 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2010.
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.
Akiva Tamir, M.D. contact
Akiva Tamir, M.D principal investigator
Tel Aviv University
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 Closure of the Foramen Ovale and Ductus Arteriosus, run by Wolfson Medical Center at 1 site in Israel.
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 1 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: status not confirmed, as of the sponsor's last update on 14 Sep 2010. 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 Israel. 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 Akiva Tamir, M.D. (tamir@wolfson.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patent Foramen Ovale size using 2 echocardiography positions, shunt direction and distance of septum primum to Superior Vena Cava (time frame: 2-3 hours after birth, 5-6 hours, 7-8 hours, 12-13 hours and 36 hours). 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 14 Sep 2010.