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Timing of Closure of Patent Foramen Ovale Following Birth

Information source: Wolfson Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Closure of the Foramen Ovale and Ductus Arteriosus

Intervention: no interventions (Device)

Phase: N/A

Status: Recruiting

Sponsored by: Wolfson Medical Center

Official(s) and/or principal investigator(s):
Akiva Tamir, M.D, Principal Investigator, Affiliation: Tel Aviv University

Overall contact:
Akiva Tamir, M.D., Email: tamir@wolfson.health.gov.il


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.

Clinical Details

Official title: Timing of Closure of Patent Foramen Ovale and Patent Ductus Arteriosus Following Birth

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: Patent Foramen Ovale size using 2 echocardiography positions, shunt direction and distance of septum primum to Superior Vena Cava

Secondary outcome: Patent Ductus Arteriosus size, shunt direction and the size of the Left Pulmonary Artery, the Right Pulmonary Artery and the Pulmonary Annulus

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.


Minimum age: N/A. Maximum age: 4 Hours. Gender(s): Both.


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


Locations and Contacts

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

Wolfson Medical Center, Holon, Israel; Recruiting
Additional Information

Starting date: December 2009
Last updated: September 12, 2010

Page last updated: August 23, 2015

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