NCT03477708

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
166

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 26, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

4.2 years

First QC Date

March 7, 2018

Last Update Submit

April 27, 2022

Conditions

ELBW - Extremely Low Birth Weight InfantIVH- Intraventricular Hemorrhage

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Study group

TCCO2 monitoring

Control group

Routine monitoring

Eligibility Criteria

Age0 Minutes - 24 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

ELBW infants

You may qualify if:

  • ELBW infants Need of respiratory support

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Medical Center

Haifa, Israel

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Liron Borenstein Levin,MD, Neonatologist

Study Record Dates

First Submitted

March 7, 2018

First Posted

March 26, 2018

Study Start

January 1, 2018

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

April 28, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)