Mask Ventilation With Different Face Masks During Neonatal Resuscitation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Two Round Face Masks During Neonatal Resuscitation

Conditions
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Respiration; Insufficient or Poor, Newborn

Intervention / Treatment
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* Procedure: Mask ventilation with a Laerdal face mask
* Procedure: Mask ventilation with a F&P face mask


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 30 Minutes

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laerdal Mask<br>Mask ventilation with a Laerdal face mask | Procedure: Mask ventilation with a Laerdal face mask<br>* 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.<br>|
| Experimental: F&P Mask<br>Mask ventilation with a F&P face mask | Procedure: Mask ventilation with a F&P face mask<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Percentage of Leak | Primary outcome: Difference in percentage of Leak | during mask ventilation in the first 5 minutes after birth |