Timing of Closure of Patent Foramen Ovale Following Birth

Wolfson Medical Center (WMC)

Status: Unknown

Conditions: Closure of the Foramen Ovale and Ductus Arteriosus

Treatments: Device: no interventions

Study type: Observational

Funder types: Other

Identifiers

NCT01032785

0049-09-WOMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 30 minutes to 4 hours old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Healthy term newborn

Description:

Any healthy term newborn born in Wolfson Medical Center

Treatment:

Device: no interventions