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Timing of Closure of Patent Foramen Ovale Following Birth

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by Wolfson Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01032785
First Posted: December 16, 2009
Last Update Posted: September 14, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Wolfson Medical Center
  Purpose
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.

Condition Intervention
Closure of the Foramen Ovale and Ductus Arteriosus Device: no interventions

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Timing of Closure of Patent Foramen Ovale and Patent Ductus Arteriosus Following Birth

Resource links provided by NLM:


Further study details as provided by Wolfson Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: December 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Healthy term newborn
Any healthy term newborn born in Wolfson Medical Center
Device: no interventions
no interventions

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 4 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Population consits of newborn babies born in term and under normal delivery in Wolfson M.C.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01032785


Contacts
Contact: Akiva Tamir, M.D. tamir@wolfson.health.gov.il

Locations
Israel
Wolfson Medical Center Recruiting
Holon, Israel
Sponsors and Collaborators
Wolfson Medical Center
Investigators
Principal Investigator: Akiva Tamir, M.D Tel Aviv University
  More Information

Responsible Party: Dr. Akiva Tamir, Head of Pediatric Cardiology Unit
ClinicalTrials.gov Identifier: NCT01032785     History of Changes
Other Study ID Numbers: 0049-09-WOMC
First Submitted: December 15, 2009
First Posted: December 16, 2009
Last Update Posted: September 14, 2010
Last Verified: September 2010

Keywords provided by Wolfson Medical Center:
Patent Foramen Ovale
Patent Ductus Arteriosus
PFO
PDA

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Foramen Ovale, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Heart Septal Defects, Atrial
Heart Septal Defects