Timing of Closure of Patent Foramen Ovale Following Birth

• Conditions: Closure of the Foramen Ovale and Ductus Arteriosus
• Interventions: Device: no interventions

• Registration Number: NCT01032785
• Lead Sponsor: Wolfson Medical Center

Brief 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.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-15
• Study First Submitted QC: 2009-12-15
• Study First Posted: 2009-12-16
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-12
• Last Update Posted: 2010-09-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy term newborn	no interventions	Any healthy term newborn born in Wolfson Medical Center

Primary Outcome Measures

Name	Time	Method
Patent Foramen Ovale size using 2 echocardiography positions, shunt direction and distance of septum primum to Superior Vena Cava	2-3 hours after birth, 5-6 hours, 7-8 hours, 12-13 hours and 36 hours

Secondary Outcome Measures

Name	Time	Method
Patent Ductus Arteriosus size, shunt direction and the size of the Left Pulmonary Artery, the Right Pulmonary Artery and the Pulmonary Annulus	2-3 hours after birth, 5-6 hours, 7-8 hours, 12-13 hours, 36 hours

Trial Locations

Locations (1)

Wolfson Medical Center; 🇮🇱 Holon, Israel