AzTrials
AzTrials

ApneaMRSOPANCT02375230

MRSOPA-Drills to Improve Mask Ventilation in the Delivery Room

A study testing MR SOPA in people with Apnea and Bradycardia, run by University of Alberta at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages Up to 10 minutes
Conditions the study is for
Apnea, Bradycardia
What is being tested?
MR SOPA
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
56 participants
Where
1 siteCanada
Study dates
May 2015to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 10 minutes
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • Infants of parents who decline consent

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Royal Alexandra Hospital

    Edmonton, Alberta, T5H 3V9

Other trials in Canada

About this study

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.

Read more

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.

Read the 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.

Conditions
Apnea, Bradycardia
Being tested
Control group, MR SOPA
Keywords
Neonatal Resuscitation, Respiratory Function Tests, Neonatal Simulation, Resuscitation Teaching
Medical subject headings
Apnea, Bradycardia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Control groupProcedure or surgery

    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.

  • MR SOPAProcedure or surgery

    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 groups in NCT02375230
Study groupRoleWhat they receive
ControlPlacebo comparator"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.
Receives: Procedure: Control group
MR SOPAActive comparatorHealth 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.
Receives: Procedure: MR SOPA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mask leak

    Measured: within 10min after birth

Secondary outcomes (4)
  1. Rate of Intubation

    Measured: within 60min after birth

  2. Apgar score at 1min

    Measured: 1min after birth

  3. Apgar score at 5min

    Measured: 5min after birth

  4. Rate of Chest compression

    Measured: within 10min after birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionSep 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02375230
Sponsor's protocol ID
Pro00054147
Acronym
MRSOPA
Status last verified
Mar 2017
First submitted
24 Feb 2015
Last updated
15 Mar 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: data will be shared after request from researchers

Questions about this trial

What is this clinical trial studying?

A study testing MR SOPA in people with Apnea and Bradycardia, run by University of Alberta at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mask leak (time frame: within 10min after birth). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2017.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in