Trial Outcomes & Findings for Mask Ventilation With Different Face Masks During Neonatal Resuscitation (NCT NCT01685697)

NCT ID: NCT01685697

Last Updated: 2018-11-07

Results Overview

Primary outcome: Difference in percentage of Leak

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 56 participants
• Primary outcome timeframe: during mask ventilation in the first 5 minutes after birth
• Results posted on: 2018-11-07

Participant Flow

March 2013 to September 2013

The study used deferred consent approach. In this approach patient are randomized and asked to participant afterwards because of minimal risk to participation this study. Therefore there are a larger number of participant at the start date of the study and if they decline to participate a lower enrolled number.

Participant milestones

Measure	Laerdal Mask Mask ventilation with a Laerdal face mask Mask ventilation with a Laerdal face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the intervention group. Mask ventilation with a F\&P face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the control group.	F&P Mask Mask ventilation with a F\&P face mask Mask ventilation with a Laerdal face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the intervention group. Mask ventilation with a F\&P face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the control group.
Overall Study STARTED	31	31
Overall Study COMPLETED	28	28
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Measure	Laerdal Mask Mask ventilation with a Laerdal face mask Mask ventilation with a Laerdal face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the intervention group. Mask ventilation with a F\&P face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the control group.	F&P Mask Mask ventilation with a F\&P face mask Mask ventilation with a Laerdal face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the intervention group. Mask ventilation with a F\&P face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the control group.
Overall Study Protocol Violation	3	3

Baseline Characteristics

Mask Ventilation With Different Face Masks During Neonatal Resuscitation

Baseline characteristics by cohort

Measure	Laerdal Mask n=28 Participants Mask ventilation with a Laerdal face mask Mask ventilation with a Laerdal face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the intervention group. Mask ventilation with a F\&P face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the control group.	F&P Mask n=28 Participants Mask ventilation with a F\&P face mask Mask ventilation with a Laerdal face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the intervention group. Mask ventilation with a F\&P face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the control group.	Total n=56 Participants Total of all reporting groups
Age, Categorical <=18 years	28 Participants n=5 Participants	28 Participants n=7 Participants	56 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous Gestational age in weeks	28 weeks STANDARD_DEVIATION 2 • n=5 Participants	28 weeks STANDARD_DEVIATION 3 • n=7 Participants	28 weeks STANDARD_DEVIATION 2 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment Canada	28 participants n=5 Participants	28 participants n=7 Participants	56 participants n=5 Participants

PRIMARY outcome

Timeframe: during mask ventilation in the first 5 minutes after birth

Primary outcome: Difference in percentage of Leak

Outcome measures

Measure	Laerdal Mask n=28 Participants Potentially eligible infants were randomized immediately prior to delivery and then received PPV as clinically necessary with either the F\&P ∅35mm or ∅42mm F\&P mask.	F&P Mask n=28 Participants Potentially eligible infants were randomized immediately prior to delivery and then received PPV as clinically necessary with either the F\&P ∅35mm or ∅42mm F\&P mask.
Difference in Percentage of Leak	35 % (percentage of mass leak) Interval 24.0 to 46.0	30 % (percentage of mass leak) Interval 25.0 to 36.0

Adverse Events

Laerdal Mask

Serious events: 2 serious events

Other events: 0 other events

Deaths: 2 deaths

F&P Mask

Serious events: 2 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Measure	Laerdal Mask n=28 participants at risk Mask ventilation with a Laerdal face mask Mask ventilation with a Laerdal face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the intervention group. Mask ventilation with a F\&P face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the control group.	F&P Mask n=28 participants at risk Mask ventilation with a F\&P face mask Mask ventilation with a Laerdal face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the intervention group. Mask ventilation with a F\&P face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the control group.
Respiratory, thoracic and mediastinal disorders Death during Admissions	7.1% 2/28 • Number of events 2	7.1% 2/28 • Number of events 2

Other adverse events

Adverse event data not reported

Additional Information

Georg Schmolzer

Univeristy of Alberta

Phone: 7807354660

Email: georg.schmoelzer@me.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place