Other Clinical Trial - The Impact of Continuous NCT03477708

Updated 06/21/2024

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT03477708
Other study ID #	TCCO2 monitoring in ELBW
Secondary ID
Status	Completed
Phase
First received
Last updated
Start date	January 1, 2018
Est. completion date	April 1, 2022

Study information
Verified date	April 2022
Source	Rambam Health Care Campus
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Observational

Clinical Trial 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.

Recruitment information / eligibility
Status	Completed
Enrollment	166
Est. completion date	April 1, 2022
Est. primary completion date	April 1, 2022
Accepts healthy volunteers	No
Gender	All
Age group	N/A to 24 Hours
Eligibility	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

Related Conditions & MeSH terms

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

Locations
Country	Name	City	State
Israel	Rambam Medical Center	Haifa

Sponsors *(1)*
Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	IVH-Intraventricular Hemorrhage	Intraventricular Hemorrhage	Repeated scans until infant reaches corrected age of 42 weeks
Primary	PVL- Periventricular Leukomalacia	Periventricular Leukomalacia	Repeated scans until infant reaches corrected age of 42 weeks

See also
	Status	Clinical Trial	Phase
	Recruiting	`NCT04413097` - Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants	N/A