The Hilo Pilot -Trial to Assess Feasibility

NACompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

November 1, 2018

Primary Completion Date

February 28, 2019

Study Completion Date

March 31, 2019

Conditions
Premature InfantRespiratory Distress Syndrome
Interventions
PROCEDURE

30% group

Infants in the 30 % group will remain in 30% oxygen (O2) until 5 min of age. At 5 min of age, the clinical team will assess oxygen saturation (SpO2). If SpO2 is \<85%, O2 should be increased by 10-20% every 60 sec to achieve SpO2 of 85% or greater or a SpO2 of 90-95% at 10 min of age. If SpO2 are greater than 95% at or before 5 min of age, O2 should be decreased stepwise (every 60 sec) with an aim to maintain SpO2 of 85% or greater during 5-10 min of age or 90-95% at and beyond 10 min of age.

PROCEDURE

60% group

Infants in the 60 % group will remain in 60% oxygen (O2) until 5 min of age. At 5 min of age, the clinical team will assess oxygen saturation (SpO2). If SpO2 is \<85%, O2 should be increased by 10-20% every 60 sec to achieve SpO2 of 85% or greater or a SpO2 of 90-95% at 10 min of age. If SpO2 are greater than 95% at or before 5 min of age, O2 should be decreased stepwise (every 60 sec) with an aim to maintain SpO2 of 85% or greater during 5-10 min of age or 90-95% at and beyond 10 min of age.

Trial Locations (1)

T5H 3V9

Royal Alexandra Hospital, Edmonton

All Listed Sponsors
lead

University of Alberta

OTHER

NCT03706586 - The Hilo Pilot -Trial to Assess Feasibility | Biotech Hunter | Biotech Hunter