Changes in Cardiac Output During Delayed Umbilical Cord C... | NCT02195037

Studies
Changes in Cardiac Output During Delayed Umbilical Cord Clamping

NCT02195037

Sponsor

Sharp HealthCare

Status

Completed

Last Update Posted

May 20, 2015Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Cardiac Output, Low

Interventions

Not provided

Countries

United States

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

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2014

Primary Completion Date

Oct 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Jul 17, 2014

First Submission Date that Met QC Criteria

Jul 17, 2014

First Posted Date

Jul 21, 2014Estimated

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

May 18, 2015

Last Update Posted Date

May 20, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Recently, the American College of Obstetricians and Gynecologists (ACOG) recommended a delay of 30-60 seconds in umbilical cord clamping for all newborn infants. This delay allows the newborn to receive his/her own blood from the placenta (placental transfusion) which helps their transition in the first hours of life. The purpose of the study is to learn about the amount of blood flow to and from the baby's heart during normal newborn transition

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

20Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cardiac Output		5 minutes of Life

Secondary Outcomes

Measure	Description	Time Frame
Stroke Volume		5 Minutes of Life
Bilirubin level		until discharge
Hemoglobin level

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy full term infants
Delivered by vaginal birth
Estimated gestational age of 37+0to 41+6 weeks corrected gestational age

Exclusion Criteria:

Multiples
Known fetal anomalies (including cardiac defects).
Instrumentation during delivery (forceps or vacuum)
Non-reducible nuchal cord during delivery.
Any maternal or neonatal indication requiring immediate cord clamping.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

1 Minute

Standard Ages

Child

Study Population

Healthy full term infants delivered by vaginal birth with an estimated gestational age of 37+1 to 41+6 weeks corrected gestational age

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anup Katheria, MD	Sharp HealthCare	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sharp Mary Birch Hospital for Women and Newborns		San Diego	California	92123	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27057332	Derived	Katheria AC, Wozniak M, Harari D, Arnell K, Petruzzelli D, Finer NN. Measuring cardiac changes using electrical impedance during delayed cord clamping: a feasibility trial. Matern Health Neonatol Perinatol. 2015 May 22;1:15. doi: 10.1186/s40748-015-0016-3. eCollection 2015.

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms