Timing of Closure of Patent Foramen Ovale Following Birth

September 12, 2010 updated by: Wolfson Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Holon, Israel
        • Recruiting
        • Wolfson Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 minutes to 4 hours (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Population consits of newborn babies born in term and under normal delivery in Wolfson M.C.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy term newborn
Any healthy term newborn born in Wolfson Medical Center
Device: no interventions
no interventions

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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
Time Frame: 2-3 hours after birth, 5-6 hours, 7-8 hours, 12-13 hours, 36 hours
2-3 hours after birth, 5-6 hours, 7-8 hours, 12-13 hours, 36 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wolfson Medical Center

Investigators

  • Principal Investigator: Akiva Tamir, M.D, Tel Aviv University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Anticipated)

March 1, 2010

Study Completion (Anticipated)

March 1, 2010

Study Registration Dates

First Submitted

December 15, 2009

First Submitted That Met QC Criteria

December 15, 2009

First Posted (Estimate)

December 16, 2009

Study Record Updates

Last Update Posted (Estimate)

September 14, 2010

Last Update Submitted That Met QC Criteria

September 12, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0049-09-WOMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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