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

NCT03477708 — Completed, 166 participants, Rambam Health Care Campus
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The Impact of Continuous Transcutaneous CO2 Monitoring (TCCO2) in Extremely Low Birth Weight (ELBW) Infants: A Prospective Observational, Multi-Center Study

RegistryNCT03477708
StatusCompleted
Study typeObservational
Enrollment166 (Actual)
SponsorRambam Health Care Campus (Other)
ConditionsELBW - Extremely Low Birth Weight Infant, IVH- Intraventricular Hemorrhage
Datesstart 2018-01-01, primary completion 2022-04-01, completion 2022-04-01, first posted 2018-03-26, last updated 2022-04-28
Locations1 site in Israel

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Study groupTCCO2 monitoring
Control groupRoutine monitoring

+Outcome measures

Primary outcomes

  • 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

+Eligibility

Sex: All, ages: 0 Minutes to 24 Hours

Inclusion Criteria:

* ELBW infants Need of respiratory support

Exclusion Criteria:

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

+Locations (1)

FacilityCityCountryStatus
Rambam Medical CenterHaifaIsrael

My Notes