Comparison of Two Pulse Oximeters in Delivery Room | NCT02704585

Studies
Comparison of Two Pulse Oximeters in Delivery Room

NCT02704585

Sponsor

Shaare Zedek Medical Center

Status

Unknown status

Last Update Posted

Mar 10, 2016Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Hypoxia

Interventions

Nellcor
Masimo

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

Mar 2016

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

Jan 2016

Primary Completion Date

Jan 2017Estimated

Completion Date

Jan 2017Estimated

First Submitted Date

Feb 24, 2016

First Submission Date that Met QC Criteria

Mar 9, 2016

First Posted Date

Mar 10, 2016Estimated

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

Mar 9, 2016

Last Update Posted Date

Mar 10, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bromiker, Ruben M.D, Senior Neonatologist, Shaare Zedek Medical CenterPrincipal Investigator

Lead Sponsor

Shaare Zedek Medical CenterOTHER

Collaborators

Not provided

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

Time to stable reading of oxygen saturation at the delivery room will be compared between two different devices.

Detailed Description

After delivery babies will be located in the radiant warmer. The probe of each pulse oximeter will be applied to one of the feet. Both probes will be simultaneously connected to the female plug of the pulse oximeter.

Heart rate will be checked

Time to get a stable reading in each device (by observation on the devices' display) will be recorded; this will be the primary study outcome. Other vital signs (oxygen saturation, heart rate) and demographics) will be recorded as well.

Paired students T test will be used for the statistical analyzes.

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nellcor	Other	Connection to Nellcor pulse oximeter for measuring oxygen saturation after birth	Device: Nellcor
Masimo	Other	Connection to Masimo pulse oximeter for measuring oxygen saturation after birth	Device: Masimo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nellcor	Device	Measurement of pulse oximetry in the delivery room with Nellcor pulse oximeter	Nellcor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to steady reading in the pulse oximeter		up to 2 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Neonates in the operation or delivery room immediately after delivery whose parents agreed to enter the study

Exclusion Criteria:

Malformation of one of the legs, not allowing sensor application. Any situation in which the study might interfere with the treatment of the newborn

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Minute

Maximum Age

15 Minutes

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yakir Shir, MD	Contact	972523121040		yakirshir@gmail.com

Overall Officials

Name	Affiliation	Role
Ruben Bromiker, MD	Shaare Zedek Medical Center	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ruben Bromiker	Recruiting	Jerusalem		91031	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21091987	Result	Baquero H, Alviz R, Castillo A, Neira F, Sola A. Avoiding hyperoxemia during neonatal resuscitation: time to response of different SpO2 monitors. Acta Paediatr. 2011 Apr;100(4):515-8. doi: 10.1111/j.1651-2227.2010.02097.x. Epub 2011 Jan 17.

ID	Term
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms