Timing of Closure of Patent Foramen Ovale Following Birth

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01032785

Enrollment

100

Registered

2009-12-16

Start date

2009-12-31

Completion date

2010-03-31

Last updated

2010-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Closure of the Foramen Ovale and Ductus Arteriosus

Keywords

Patent Foramen Ovale, Patent Ductus Arteriosus, PFO, PDA

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.

Interventions

DEVICEno interventions

no interventions

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Minutes to 4 Hours

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Israel

Contacts

Primary ContactAkiva Tamir, M.D.

tamir@wolfson.health.gov.il

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026