ClinicalTrials.gg
Sign In
CompletedNCT03477708Updated Apr 28, 2022

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

An observational study in ELBW - Extremely Low Birth Weight Infant and IVH- Intraventricular Hemorrhage, sponsored by Rambam Health Care Campus. Completed at 1 site in Israel. Open to participants aged 0 Minutes to 24 Hours. Per ClinicalTrials.gov, last updated 2022-04-28.

Sponsored by Rambam Health Care Campus · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
166
Ages
0 Minutes to 24 Hours
Sex
All
01

Study 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.

02

Conditions studied

  • ELBW - Extremely Low Birth Weight Infant
  • IVH- Intraventricular Hemorrhage

Browse trials for

03

In context

Birth Weight

185 studies on the registry are indexed under Birth Weight; 25 are open to participants now.

This study's enrollment of 166 is below the median of 240 across 63 observational studies indexed under Birth Weight.

Browse Birth Weight studies →

Lead sponsor

Rambam Health Care Campus is the lead sponsor of 466 studies on the registry; 34 are open to participants now.

Browse Rambam Health Care Campus studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Minutes to 24 Hours
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

ELBW infants

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ELBW infants Need of respiratory support

Exclusion criteria

Exclusion Criteria:

  • Parental refusal IVH before study entry chromosomal abnormalities congenital central nervous system (CNS) abnormalities
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
166 participants (actual)
Patient registry
No

Groups and cohorts

  • Study group

    TCCO2 monitoring

  • Control group

    Routine monitoring

06

What researchers measure

Primary outcomes

  1. IVH-Intraventricular Hemorrhage

    Intraventricular Hemorrhage

    Time frame: Repeated scans until infant reaches corrected age of 42 weeks

  2. PVL- Periventricular Leukomalacia

    Periventricular Leukomalacia

    Time frame: Repeated scans until infant reaches corrected age of 42 weeks

07

Study locations

1 site
  • Rambam Medical Center
    Haifa, Israel
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2018 to primary completion in Apr 2022, 51 months.

Of 33 non-industry observational studies under Birth Weight, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 52. This study's 51 months is above that.

Counting every sponsor, half of 34 studies reached it within 25 months; a quarter within 10 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 7, 2018
First posted
Mar 26, 2018
StartActual
Jan 1, 2018
Primary completionActual
Apr 1, 2022
CompletionActual
Apr 1, 2022
Last update
Apr 28, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03477708
Lead sponsor
Rambam Health Care Campus
Responsible party
Liron Borenstein MD (Liron Borenstein Levin,MD, Neonatologist, Rambam Health Care Campus) — Principal investigator
First posted
Mar 26, 2018
Start date
Jan 1, 2018
Primary completion
Apr 1, 2022
Completion
Apr 1, 2022
Last update
Apr 28, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Birth Weight →

Other studies from this sponsor

Rambam Health Care Campus →

Start the discussion