NCT01032785

Timing of Closure of Patent Foramen Ovale Following Birth

Timing of Closure of Patent Foramen Ovale and Patent Ductus Arteriosus Following Birth

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Wolfson Medical Center · Other Government
• Sex: All
• Age: 30 Minutes – 4 Hours
• Healthy volunteers: Accepted

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.

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.

Conditions

• Closure of the Foramen Ovale and Ductus Arteriosus

Interventions

Type	Name	Description
DEVICE	no interventions	no interventions

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2009-12-16
• Last updated: 2010-09-14

Locations

1 site across 1 country: Israel