Timing of Closure of Patent Foramen Ovale Following Birth

Closure of the Foramen Ovale and Ductus Arteriosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01032785
• Other study ID #: 0049-09-WOMC
• Status: Recruiting
• Phase: N/A
• First received: December 15, 2009
• Last updated: September 12, 2010
• Start date: December 2009
• Est. completion date: March 2010

Study information

• Verified date: September 2010
• Source: Wolfson Medical Center
• Contact: Akiva Tamir, M.D.
• Email: tamir[@]wolfson.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 4 Hours

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Closure of the Foramen Ovale and Ductus Arteriosus
• Ductus Arteriosus, Patent
• Foramen Ovale, Patent

Intervention

Device:
• no interventions
no interventions

Locations

Country	Name	City	State
Israel	Wolfson Medical Center	Holon

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No