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
  Purpose

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.


Condition Intervention
Closure of the Foramen Ovale and Ductus Arteriosus
Device: no interventions

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Timing of Closure of Patent Foramen Ovale and Patent Ductus Arteriosus Following Birth

Resource links provided by NLM:


Further study details as provided by Wolfson Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: December 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Healthy term newborn
Any healthy term newborn born in Wolfson Medical Center
Device: no interventions
no interventions
Other Name: no interventions

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.

  Eligibility

Ages Eligible for Study:   up to 4 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01032785

Contacts
Contact: Akiva Tamir, M.D. tamir@wolfson.health.gov.il

Locations
Israel
Wolfson Medical Center Recruiting
Holon, Israel
Sponsors and Collaborators
Wolfson Medical Center
Investigators
Principal Investigator: Akiva Tamir, M.D Tel Aviv University
  More Information

No publications provided

Responsible Party: Dr. Akiva Tamir, Head of Pediatric Cardiology Unit
ClinicalTrials.gov Identifier: NCT01032785     History of Changes
Other Study ID Numbers: 0049-09-WOMC
Study First Received: December 15, 2009
Last Updated: September 12, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Wolfson Medical Center:
Patent Foramen Ovale
Patent Ductus Arteriosus
PFO
PDA

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Foramen Ovale, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Heart Septal Defects, Atrial
Heart Septal Defects

ClinicalTrials.gov processed this record on September 18, 2014