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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05144724
Other study ID # Pro00115050
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2024
Est. completion date December 31, 2024

Study information

Verified date June 2024
Source University of Alberta
Contact Georg Schmölzer, MD, PhD
Phone +17807354647
Email georg.schmoelzer@me.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a pilot trial to assess the feasibility of volume Targeted Ventilation in the Delivery Room. Preterm infants will be randomized to pressure guided or volume targeted ventilation during respiratory support in the delivery room


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date December 31, 2024
Est. primary completion date August 30, 2024
Accepts healthy volunteers No
Gender All
Age group 0 Minutes to 1 Minute
Eligibility Inclusion Criteria: - Preterm infants 23-28 weeks' gestation requiring respiratory support at birth will be eligible for the trial. Inclusion criteria are pragmatic to enable the inclusion of ELGAN infants (Extremely Low Gestational Age Newborns). Exclusion Criteria: - Infants will be excluded if they have a congenital abnormality or condition that might have an adverse effect on breathing or ventilation (e.g., congenital diaphragmatic hernia), or congenital heart disease requiring intervention in the neonatal period. - Infants will also be excluded if their parents refuse to give consent to this study.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Volume targeted ventilation
Positive pressure ventilation will be provided using a set tidal volume
Pressure targeted ventilation
Positive pressure ventilation will be provided using a set peak inflation pressure

Locations

Country Name City State
Canada Royal Alexandra Hospital Edmonton Alberta

Sponsors (1)

Lead Sponsor Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of preterm infants receiving the intervention Number of Participants who have received allocated treatment Through study completion (total 18 months)
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