- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01032785
Timing of Closure of Patent Foramen Ovale Following Birth
September 12, 2010 updated by: Wolfson Medical Center
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.
Study Overview
Status
Unknown
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Akiva Tamir, M.D.
- Email: tamir@wolfson.health.gov.il
Study Locations
-
-
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Holon, Israel
- Recruiting
- Wolfson Medical Center
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 minutes to 4 hours (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Population consits of newborn babies born in term and under normal delivery in Wolfson M.C.
Description
Inclusion Criteria:
- any baby born in term and with normal delivery
Exclusion Criteria:
- sick newborns in need of neonatal intensive care for any medical reason.
- newborns with congenital heart disease except for small, muscular ventricular septal defects
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy term newborn
Any healthy term newborn born in Wolfson Medical Center
|
no interventions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
2-3 hours after birth, 5-6 hours, 7-8 hours, 12-13 hours and 36 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
2-3 hours after birth, 5-6 hours, 7-8 hours, 12-13 hours, 36 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Akiva Tamir, M.D, Tel Aviv University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Anticipated)
March 1, 2010
Study Completion (Anticipated)
March 1, 2010
Study Registration Dates
First Submitted
December 15, 2009
First Submitted That Met QC Criteria
December 15, 2009
First Posted (Estimate)
December 16, 2009
Study Record Updates
Last Update Posted (Estimate)
September 14, 2010
Last Update Submitted That Met QC Criteria
September 12, 2010
Last Verified
September 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0049-09-WOMC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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