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

Completed

• Conditions: IVH- Intraventricular Hemorrhage; ELBW - Extremely Low Birth Weight Infant

• Registration Number: NCT03477708
• Lead Sponsor: Rambam Health Care Campus

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 available

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-03-07
• Study First Submitted QC: 2018-03-19
• Study First Posted: 2018-03-26
• Status Verified: 2022-04
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01
• Last Update Submitted: 2022-04-27
• Last Update Posted: 2022-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

Inclusion Criteria

• ELBW infants Need of respiratory support

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IVH-Intraventricular Hemorrhage	Repeated scans until infant reaches corrected age of 42 weeks	Intraventricular Hemorrhage
PVL- Periventricular Leukomalacia	Repeated scans until infant reaches corrected age of 42 weeks	Periventricular Leukomalacia

Trial Locations

Locations (1)

Rambam Medical Center; 🇮🇱 Haifa, Israel