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Timing of Closure of Patent Foramen Ovale Following Birth

NCT ID: NCT01032785

Last Updated: 2010-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-03-31

Brief Summary

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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

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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.

Conditions

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Closure of the Foramen Ovale and Ductus Arteriosus

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy term newborn

Any healthy term newborn born in Wolfson Medical Center

no interventions

Intervention Type DEVICE

no interventions

Interventions

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no interventions

no interventions

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

30 Minutes

Maximum Eligible Age

4 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wolfson Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Head of Pediatric Cardiology Unit

Principal Investigators

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Akiva Tamir, M.D

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv University

Locations

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Wolfson Medical Center

Holon, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Akiva Tamir, M.D.

Role: CONTACT

[email protected]

Other Identifiers

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0049-09-WOMC

Identifier Type: -

Identifier Source: org_study_id