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MRSOPA-Drills to Improve Mask Ventilation in the Delivery Room (MRSOPA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02375230
Recruitment Status : Completed
First Posted : March 2, 2015
Last Update Posted : March 15, 2017
Sponsor:
Collaborator:
American Academy of Pediatrics
Information provided by (Responsible Party):
University of Alberta

Brief Summary:

Establishing breathing after birth is vital for survival and long-term health of premature babies. 10% of all preterm babies fail to breathe after birth and require help with breathing. When infants need help with breathing the clinical team will place a small mask on the babies face to give some breaths to help the baby breath (what the investigators call mask ventilation).

This procedure is done million times a day around the world and several times a day here at the Royal Alexandra Hospital. Providing these breaths via mask ventilation is the most difficult step in helping a baby breath at birth. If this is provided wrongly then baby does not receive enough oxygen, which could damage the brain and even cause death.

To keep the skill level of every staff member up-to-date every staff member is required to re-train this rescue breaths via mask ventilation once every two years.

The investigators believe this is not enough and that daily trainings are necessary to keep your skills up-to-date.

The investigators aim to compare to different teaching techniques using daily trainings to see if either improves the skills of the resuscitator providing mask ventilation

The study will last 7 month (baseline observations (2 months), intervention period (3 months), After trial period (2 months)

The investigators will use our routinely used equipment to record neonatal resuscitation and the investigators also routinely make video recordings to evaluate performance during resuscitation.


Condition or disease Intervention/treatment Phase
Apnea Bradycardia Procedure: Control group Procedure: MR SOPA Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: MRSOPA-Drills to Improve Mask Ventilation in the Delivery Room
Study Start Date : May 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : December 2016

Arm Intervention/treatment
Placebo Comparator: Control

"Control group"

Health care provider randomized to the control group will receive a copy of the NRP text pages discussing MR SOPA at every shift for self-study. They will be encouraged by the educator to study these pages for five minutes at every shift. The educator will be there to answer questions if they arise.

Procedure: Control group
Health care provider randomized to the control group will receive a copy of the NRP text pages discussing MR SOPA at every shift for self-study. They will be encouraged by the educator to study these pages for five minutes at every shift. The educator will be there to answer questions if they arise.

Active Comparator: MR SOPA

Health care provider randomized to the "MR SOPA" group will receive MR SOPA training provided by a qualified educator on every shift. This training will be five minutes long and will consist of each MR SOPA step. These corrective steps will be demonstrated and practiced on a low-fidelity neonatal mannequin. Each participant will receive five minutes of training at the start of each shift.

The educator will teach mask adjustment, and airway reposition. If either of these first steps is unsuccessful the participant will learn about mouth and nose suction, open mouth and increase of airway pressure. All participants will also learn and practice alternative airways placement including intubation and laryngeal mask airway placement.

Procedure: MR SOPA
Health care provider randomized to the "MR SOPA" group will receive MR SOPA training provided by a qualified educator on every shift. This training will be five minutes long and will consist of each MR SOPA step. These corrective steps will be demonstrated and practiced on a low-fidelity neonatal mannequin. The alternative airway practice will be performed on an intubation mannequin in the DR also placed on the DR resuscitation unit. Each participant will receive five minutes of training at the start of each shift.




Primary Outcome Measures :
  1. Mask leak [ Time Frame: within 10min after birth ]

Secondary Outcome Measures :
  1. Rate of Intubation [ Time Frame: within 60min after birth ]
  2. Apgar score at 1min [ Time Frame: 1min after birth ]
  3. Apgar score at 5min [ Time Frame: 5min after birth ]
  4. Rate of Chest compression [ Time Frame: within 10min after birth ]


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Ages Eligible for Study:   up to 10 Minutes   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants <33 weeks gestation requiring respiratory support at birth will be included if member of the Resuscitation-Stabilization-Triage team (RST-team) enrolled in study attend deliveries.

Exclusion Criteria:

  • Infants of parents who decline consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02375230


Locations
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Canada, Alberta
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
Sponsors and Collaborators
University of Alberta
American Academy of Pediatrics
Investigators
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Principal Investigator: Georg Schmolzer, MD,PhD University of Alberta

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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT02375230     History of Changes
Other Study ID Numbers: Pro00054147
First Posted: March 2, 2015    Key Record Dates
Last Update Posted: March 15, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: data will be shared after request from researchers
Keywords provided by University of Alberta:
Neonatal Resuscitation
Respiratory Function Tests
Neonatal Simulation
Resuscitation Teaching
Additional relevant MeSH terms:
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Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes