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.
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.
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 group | Role | What they receive |
|---|---|---|
| Control | Placebo 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 SOPA | Active comparator | 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. Receives: Procedure: MR SOPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mask leak
Measured: within 10min after birth
Secondary outcomes (4)
Rate of Intubation
Measured: within 60min after birth
Apgar score at 1min
Measured: 1min after birth
Apgar score at 5min
Measured: 5min after birth
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.
- First posted2 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionSep 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ApneaStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Pediatrics
- Responsible party
- Sponsor
- Investigators
- Georg Schmolzer, MD,PhD, Principal investigator, University of Alberta
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRSOPA-Drills to Improve Mask Ventilation in the Delivery Room
- ClinicalTrials.gov ID
- NCT02375230
- Acronym / sponsor ID
- MRSOPA / Pro00054147
- Conditions
- Apnea, Bradycardia
- Keywords
- Neonatal Resuscitation, Respiratory Function Tests, Neonatal Simulation, Resuscitation Teaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- American Academy of Pediatrics
- Study start
- May 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 2 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Procedure: Control group"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. |
| MR SOPA | Active comparator | Procedure: MR SOPAHealth 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. |
Who may qualify
- Ages
- Up to 10 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Infants of parents who decline consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control groupHealth 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 or surgery | Control |
| MR SOPAHealth 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. | Procedure or surgery | MR SOPA |
Primary outcome
Mask leak
Time frame: within 10min after birth
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2017.
- Individual participant dataSharing planned: Yes. data will be shared after request from researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georg Schmolzer, MD,PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
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.