Timing of Closure of Patent Foramen Ovale Following Birth

NCT01032785 | Unknown DMC

• 1 other identifier: 0049-09-WOMC
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Closure of the Foramen Ovale and Ductus Arteriosus

Keywords

Patent Foramen Ovale; Patent Ductus Arteriosus; PFO; PDA

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (1)

Healthy term newborn

Any healthy term newborn born in Wolfson Medical Center

Device: no interventions

Interventions

no interventions DEVICE

no interventions

Healthy term newborn

Eligibility Criteria

• Age: 30 Minutes - 4 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• any baby born in term and with normal delivery

You may not qualify if:

• sick newborns in need of neonatal intensive care for any medical reason.
• newborns with congenital heart disease except for small, muscular ventricular septal defects

Sponsors & Collaborators

• Wolfson Medical Center: lead

Study Sites (1)

Wolfson Medical Center

Holon, Israel

RECRUITING

MeSH Terms

Conditions

Ductus Arteriosus, Patent; Foramen Ovale, Patent

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Septal Defects, Atrial; Heart Septal Defects

Study Officials

• Akiva Tamir, M.D

  Tel Aviv University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Akiva Tamir, M.D.

CONTACT

tamir@wolfson.health.gov.il

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: December 15, 2009
• First Posted: December 16, 2009
• Study Start: December 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: September 14, 2010

Record last verified: 2010-09

Locations

IL (1)