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Mask Ventilation With Different Face Masks During Neonatal Resuscitation

NCT01685697 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2018-11-07

Study results available
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Summary

Most premature babies have difficulty breathing at birth and need help (what we call resuscitation). The treatment for this is to gently inflate their lungs with a resuscitation device and a facemask. The device commonly used is a T-Piece infant resuscitator (which we call the T-Piece) and is used at The Royal Alexandra Hospital and all round the world.

To gentle inflate an infants lung the clinical team put a face mask around your baby's mouth and nose. The clinical team tries to achieve a good seal between the face and the mask. A problem of mask ventilation is that air can escape between the mask and the face (what we call mask leak). Currently, two different types of facemasks ("Laerdal mask" or "Fisher \& Paykel mask") are routinely used in the delivery room at The Royal Alexandra Hospital.

The purpose of this study is to find out if one facemask is leaking less between the face and the mask.

Conditions

  • Respiration; Insufficient or Poor, Newborn

Interventions

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Principal Investigators

  • Georg Schmolzer, MD,PhD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
30 Minutes
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01685697 on ClinicalTrials.gov