Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE February 24, 2015
First Posted Date  ICMJE March 2, 2015
Last Update Posted Date March 15, 2017
Study Start Date  ICMJE May 2015
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2015)
Mask leak [ Time Frame: within 10min after birth ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2015)
  • Rate of Intubation [ Time Frame: within 60min after birth ]
  • Apgar score at 1min [ Time Frame: 1min after birth ]
  • Apgar score at 5min [ Time Frame: 5min after birth ]
  • Rate of Chest compression [ Time Frame: within 10min after birth ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MRSOPA-Drills to Improve Mask Ventilation in the Delivery Room
Official Title  ICMJE MRSOPA-Drills to Improve Mask Ventilation in the Delivery Room
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.

Detailed Description

Background

Establishing breathing and oxygenation after birth is vital for survival and long-term health of premature infants. 10% of all preterm infants fail to breathe after birth and require respiratory support. An international consensus statement recommends that infants with inadequate breathing or bradycardia after birth be given positive pressure ventilation (PPV) via a facemask with a T-piece device. Mannequin and DR studies have shown that PPV is difficult and mask leak and airway obstruction are common problems during PPV. Several factors such as poor facemask application resulting in leak or airway obstruction, spontaneous movements of the baby, movements by or distraction of the resuscitator, changing the wet towels or putting a hat can reduce the effectiveness of PPV. We recently reported both that significant airway obstruction and mask leaks occur in about half of the very preterm infants who received PPV in the DR. In particular, large mask leak was observed in twice as many recordings as airway obstruction and only in about a third of recordings neither obstruction nor facemask leak occurred. In addition, mask leak was more likely to occur at the start of PPV, while airway obstruction more often occurred later on. Assessment of the infant may distract the resuscitators focus from mask position and mask holding techniques during the initial phase of PPV.

MR SOPA

Neonatal Resuscitation Program (NRP) emphasizes on the ventilation corrective steps to ensure effective mask ventilation before moving to the next steps of resuscitation. Technique for improving PPV by mask is performed by a series of corrective steps, identified by the acronym "MR SOPA", to recall ventilation corrective steps. The steps should be followed with this order: "M Mask adjustment, R Reposition airway, S Suction mouth and nose, O Open mouth, P Pressure increase, A Airway alternative".

Hypotheses to be tested

We hypothesize that improved mask ventilation techniques using daily MRSOPA-Drills (MR SOPA group) compared to standard NRP teaching (control group) will reduce mask leak in preterm infants <33 weeks gestation who requiring breathing support at birth. We aim to determine if daily MR SOPA Drills compared to standard NRP teaching improves mask ventilation.

Experimental design and methods

Study population: 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.

Study design: Randomized controlled trial.

Participants: Members of the RST-team, which usually consists of a neonatal nurse (n=50), neonatal respiratory therapist (n=30), neonatal nurse practitioner (n=16) or neonatal fellow (n=6), and a neonatal consultant (n=15). Deliveries are usually attended by a minimum of three RST-Team members: a neonatal nurse, neonatal respiratory therapist and neonatal nurse practitioner or neonatal fellow. Participants of each professional group will be randomized after informed consent and members of each professional group will be stratified to both groups.

In addition, should state that babies health information will be collected

Description of interventions and timeline

Interventions for both groups ("MR SOPA group" and "control group")

Baseline (2 months)

Over a period of two months all participants will be recorded during several real-life resuscitations using our unique recording system (including respiratory function monitoring and video recordings) to establish a baseline of mask PPV performance.

Intervention period

"MR SOPA group"

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 in the DR of the Royal Alexandra Hospital. The mannequin will be placed on our DR resuscitation unit to simulate real-life scenarios. 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.

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.

"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.

After trial period (2 months)

After recruiting and training the study participants in the intervention period the real life resuscitations will be recorded similarly as in the pre-trial period over the next two months, using our unique recording system. This period will be compared to the baselines measures in the pre-trial period.

Resuscitation

All resuscitative measures will be decided by the RST-team, in accordance with the 2010 guidelines for neonatal resuscitation.

Equipment for recording resuscitations

We will use our routinely used equipment to record neonatal resuscitation including a user-friendly respiratory function monitor will measure respiratory parameters including tidal volume, airway pressures, gas flow, minute ventilation, and exhaled CO2. Percutaneous oxygen saturation will be assessed using pulse oximetery and systemic and regional hemodynamic function will be assessed using heart rate, and blood pressure. A high-definition digital video of these resuscitations will be made using a webcam.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Apnea
  • Bradycardia
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.

    Intervention: Procedure: Control group
  • 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.

    Intervention: Procedure: MR SOPA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 27, 2015)
56
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 10 Minutes   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02375230
Other Study ID Numbers  ICMJE Pro00054147
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: data will be shared after request from researchers
Responsible Party University of Alberta
Study Sponsor  ICMJE University of Alberta
Collaborators  ICMJE American Academy of Pediatrics
Investigators  ICMJE
Principal Investigator: Georg Schmolzer, MD,PhD University of Alberta
PRS Account University of Alberta
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP