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