The Impact of Continuous Transcutaneous CO2 (TCCO2) Monit... | NCT03477708

Studies
The Impact of Continuous Transcutaneous CO2 (TCCO2) Monitoring in Extremely Low Birth Weight (ELBW) Infants

NCT03477708

Sponsor

Rambam Health Care Campus

Status

Completed

Last Update Posted

Apr 28, 2022Actual

Enrollment

166Actual

Phase

Not provided

Conditions

ELBW - Extremely Low Birth Weight Infant
IVH- Intraventricular Hemorrhage

Interventions

Not provided

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

Apr 2022

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

Jan 1, 2018Actual

Primary Completion Date

Apr 1, 2022Actual

Completion Date

Apr 1, 2022Actual

First Submitted Date

Mar 7, 2018

First Submission Date that Met QC Criteria

Mar 19, 2018

First Posted Date

Mar 26, 2018Actual

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

Apr 27, 2022

Last Update Posted Date

Apr 28, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Liron Borenstein MD, Liron Borenstein Levin,MD, Neonatologist, Rambam Health Care CampusPrincipal Investigator

Lead Sponsor

Rambam Health Care CampusOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

An observational study comparing outcomes of Extremely Low Birth Weight (ELBW) infants that were monitored with non-invasive Transcutaneous CO2 (TCCO2) monitor to infants that were not monitored by TCCO2 monitor.

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

166Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group		TCCO2 monitoring
Control group		Routine monitoring

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
IVH-Intraventricular Hemorrhage	Intraventricular Hemorrhage	Repeated scans until infant reaches corrected age of 42 weeks
PVL- Periventricular Leukomalacia	Periventricular Leukomalacia	Repeated scans until infant reaches corrected age of 42 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ELBW infants Need of respiratory support

Exclusion Criteria:

Parental refusal IVH before study entry chromosomal abnormalities congenital central nervous system (CNS) abnormalities

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Minutes

Maximum Age

24 Hours

Standard Ages

Child

Study Population

ELBW infants

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided