Timing of Closure of Patent Foramen Ovale Following Birth | NCT01032785

Studies
Timing of Closure of Patent Foramen Ovale Following Birth

NCT01032785

Sponsor

Wolfson Medical Center

Status

Unknown status

Last Update Posted

Sep 14, 2010Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Closure of the Foramen Ovale and Ductus Arteriosus

Interventions

no interventions

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

Mar 2010Estimated

Completion Date

Mar 2010Estimated

First Submitted Date

Dec 15, 2009

First Submission Date that Met QC Criteria

Dec 15, 2009

First Posted Date

Dec 16, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2010

Last Update Posted Date

Sep 14, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy term newborn		Any healthy term newborn born in Wolfson Medical Center	Device: no interventions

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no interventions	Device	no interventions	Healthy term newborn

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Minutes

Maximum Age

4 Hours

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Akiva Tamir, M.D.	Contact			tamir@wolfson.health.gov.il

Overall Officials

Name	Affiliation	Role
Akiva Tamir, M.D	Tel Aviv University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wolfson Medical Center	Recruiting	Holon			Israel

Condition Browse Module

MeSH Terms

ID	Term
D004374	Ductus Arteriosus, Patent
D054092	Foramen Ovale, Patent

Ancestor Terms

ID	Term
D006330	Heart Defects, Congenital
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D006331	Heart Diseases

Browse Leaves

Not provided

Browse Branches

Not provided