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Clinical Trials/NCT06458582
NCT06458582
Completed
Not Applicable

High Flow Nasal Cannula is Appropriate Alternative for Stabilization of Very Premature Infants: a Prospective Observational Study

Charles University, Czech Republic1 site in 1 country65 target enrollmentFebruary 1, 2021
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ConditionsPremature; Infant

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Premature; Infant
Sponsor
Charles University, Czech Republic
Enrollment
65
Locations
1
Primary Endpoint
HFNC slabilization
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

A prospective observational study evaluates the safety and efficacy of using High-Flow Nasal Cannula to stabilize very preterm infants immediately after birth. Following placental transfusion, high flow nasal cannula at 8 l/min is administered along with intermittent tactile stimulation. Criteria for switching to other interventions like continuous positive airway pressure or positive pressure ventilation are set for cases of persistent bradycardia or low SpO2.

Registry
clinicaltrials.gov
Start Date
February 1, 2021
End Date
December 31, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Charles University, Czech Republic
Responsible Party
Principal Investigator
Principal Investigator

Jonáš Klára

Principal Investigator

Charles University, Czech Republic

Eligibility Criteria

Inclusion Criteria

  • •Preterm infants born between 28+0 and 31+6 gestational weeks were enrolled in the study after obtaining parental informed consent.

Exclusion Criteria

  • •Infants with congenital malformations, previable rupture of membranes, and acute intrauterine hypoxia.

Outcomes

Primary Outcomes

HFNC slabilization

Time Frame: 10 minutes after delivery

Number of infants who were stabilized after birth on high flow nasal cannula exclusively without any other use of artificial external pressures.

Study Sites (1)

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