NCT02704585

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 10, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

March 10, 2016

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

February 24, 2016

Last Update Submit

March 9, 2016

Conditions

Hypoxia

Keywords

Neonatal resuscitationPulse oximetry

Outcome Measures

Primary Outcomes (1)

  • Time to steady reading in the pulse oximeter

    up to 2 minutes

Study Arms (2)

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

NellcorDEVICE

Measurement of pulse oximetry in the delivery room with Nellcor pulse oximeter

Nellcor
MasimoDEVICE

Measurement of pulse oximetry in the delivery room with Masimo pulse oximeter

Masimo

Eligibility Criteria

Age1 Minute - 15 Minutes
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruben Bromiker

Jerusalem, 91031, Israel

RECRUITING

Related Publications (1)

  • 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.

    PMID: 21091987RESULT

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ruben Bromiker, MD

    Shaare Zedek Medical Center

    STUDY CHAIR

Central Study Contacts

Yakir Shir, MD

CONTACT

972523121040yakirshir@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Neonatologist

Study Record Dates

First Submitted

February 24, 2016

First Posted

March 10, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

March 10, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)