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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
03

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

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
04

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

05

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

06

Study locations

1 site
  • Rambam Medical Center
    Haifa, Israel
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

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 ↗

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

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