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Timing of Closure of Patent Foramen Ovale Following Birth

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Wolfson Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01032785
First received: December 15, 2009
Last updated: September 12, 2010
Last verified: September 2010
History of Changes

December 15, 2009
September 12, 2010
December 2009
March 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01032785 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Timing of Closure of Patent Foramen Ovale Following Birth
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.

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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Population consits of newborn babies born in term and under normal delivery in Wolfson M.C.
Closure of the Foramen Ovale and Ductus Arteriosus
Device: no interventions
no interventions
Other Name: no interventions
Healthy term newborn
Any healthy term newborn born in Wolfson Medical Center
Intervention: Device: no interventions
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
March 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
up to 4 Hours
Yes
Contact: Akiva Tamir, M.D. tamir@wolfson.health.gov.il
Israel
 
NCT01032785
0049-09-WOMC
Yes
Dr. Akiva Tamir, Head of Pediatric Cardiology Unit
Wolfson Medical Center
Not Provided
Principal Investigator: Akiva Tamir, M.D Tel Aviv University
Wolfson Medical Center
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP