Respiration; Insufficient or Poor, Newborn
Conditions
Brief 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.
Detailed description
We will use a Laerdal round mask (Laerdal, Stavanger, Norway) compared to a Fisher & Paykel (FP) (Fisher & Paykel Healthcare, Auckland, New Zealand) 'round' neonatal resuscitation mask. The two point top hold for Laerdal 'round' mask and the rim hold for the Fisher & Paykel mask. A Respiratory Function Monitor will be placed between the face mask and the ventilation device. It uses a small (dead space 1 mL) flow sensor to measure gas flow in and out of a face mask. This signal is automatically integrated to provide inspired and expired tidal volume. The difference equals the leak from the face mask. It also calculates respiratory rate and minute ventilation, measures spontaneous inspirations and ventilation pressures. The signals of airway flow, tidal volumes, airway pressure, inspired oxygen concentration, temperature, blood pressure, oxygen saturation, heart rate will be digitised and recorded at 200Hz using the Spectra physiological recording program (a customised neonatal respiratory physiology program). We will compare the % of mask leak within the two face masks.
Interventions
PROCEDUREMask 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.
PROCEDUREMask 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
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 30 Minutes
Healthy volunteers
No
Inclusion criteria
* Preterm infants \<32 weeks gestation born at The Royal Alexandra Hospital who require resuscitation in the delivery room will be recorded.
Exclusion criteria
* Infants will be excluded from final analysis if they have a congenital abnormality or condition that might have an adverse effect on breathing or ventilation, including: Congenital Diaphragmatic Hernia. Infants will also be excluded if their parents refuse to give consent to this study. Participants will be included in the first minutes after birth if they require mask ventilation for poor respiratory effort. Data will be collected from the Hospital chart until discharge at around 40 weeks gestation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Percentage of Leak | during mask ventilation in the first 5 minutes after birth | Primary outcome: Difference in percentage of Leak |
Countries
Canada
Participant flow
Recruitment details
March 2013 to September 2013
Pre-assignment details
The study used deferred consent approach. In this approach patient are randomized and asked to participant afterwards because of minimal risk to participation this study. Therefore there are a larger number of participant at the start date of the study and if they decline to participate a lower enrolled number.
Participants by arm
| Arm | Count |
|---|---|
| Laerdal Mask Mask ventilation with a Laerdal face mask
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.
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. | 28 |
| F&P Mask Mask ventilation with a F&P face mask
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.
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. | 28 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 3 | 3 |
Baseline characteristics
| Characteristic | F&P Mask | Total | Laerdal Mask |
|---|---|---|---|
| Age, Categorical <=18 years | 28 Participants | 56 Participants | 28 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous Gestational age in weeks | 28 weeks STANDARD_DEVIATION 3 | 28 weeks STANDARD_DEVIATION 2 | 28 weeks STANDARD_DEVIATION 2 |
| Region of Enrollment Canada | 28 participants | 56 participants | 28 participants |
| Sex: Female, Male Female | 13 Participants | 26 Participants | 13 Participants |
| Sex: Female, Male Male | 15 Participants | 30 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 28 | 2 / 28 |
| other Total, other adverse events | 0 / 28 | 0 / 28 |
| serious Total, serious adverse events | 2 / 28 | 2 / 28 |
Outcome results
Primary
Difference in Percentage of Leak
Primary outcome: Difference in percentage of Leak
Time frame: during mask ventilation in the first 5 minutes after birth
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Laerdal Mask | Difference in Percentage of Leak | 35 % (percentage of mass leak) |
| F&P Mask | Difference in Percentage of Leak | 30 % (percentage of mass leak) |