Non-inflatable Supraglottic Airway (NI-SGA) vs. Face Mask (FM) as a Primary Interface Device for Neonatal Resuscitation

Study Overview
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Brief Summary
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Prospective, randomized controlled trial to be performed at one center, of term and late preterm infants requiring resuscitation. Prenatal consent will be obtained. At randomization, babies will be resuscitated following Neonatal Resuscitation Program (NRP) guidelines and ventilated using the T-piece resuscitator with either a Face Mask (FM) or Non-inflating supraglottic airway. Video will be collected during resuscitation as well as written documentation. Primary outcome will be time to spontaneous breathing, length of resuscitation, and need for endotracheal intubation.

Detailed Description
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Mothers who are close to delivery of a term or near term infant with estimated fetal weight of 2500gms will be approached for consent to randomize their infant to resuscitation with mask or non-inflatable supraglottic airway (NISGA) if resuscitation is required. Study personnel in delivery will open sequential envelopes with randomized code to indicate which device is to be used if necessary. The resuscitator will be blinded until determination of need of respiratory support. At that time, the appropriate randomized device (face mask or NISGA) will be handed to the resuscitator for use along with T-Piece resuscitator. Video data capture will be used to record type, length and response to resuscitation. This information will be translated to a database prior to destruction of video.

Official Title
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Non-inflatable Supraglottic Airway (NI-SGA) vs. Face Mask (FM) as a Primary Interface Device for Neonatal Resuscitation: A Pilot Study

Conditions
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Neonatal Resuscitation

Intervention / Treatment
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* Device: Non-inflatable supraglottic airway
* Device: Face Mask
* Device: T-Piece Resuscitator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newborns > or = 2000gms requiring positive pressure ventilation within the first 2 minutes of life Exclusion Criteria: Newborns with expected fetal weight <2000 grams Known congenital malformations Multiple gestation (twins and above) History of meconium stained fluid

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Face Mask<br>Standard Face Mask with T piece resuscitator for neonatal resuscitation. Face mask placement per Neonatal Resuscitation Program resuscitation guideline. | Device: Face Mask<br>* at delivery - standard airway management per Neonatal Resuscitation Program utilizing face mask.<br>Device: T-Piece Resuscitator<br>* T-Piece Resuscitator for providing postivie pressure ventilation via face mask or non-inflatable supraglottic airway<br>|
| Active Comparator: Non-inflatable supraglottic airway<br>Use of non-inflating supraglottic airway with T-piece resuscitator instead of Standard Face Mask with T piece resuscitator for neonatal resuscitation, replacing standard of care face mask in Neonatal Resuscitation Program guideline. | Device: Non-inflatable supraglottic airway<br>* at delivery if resuscitation is required infant randomized to NI-SGA or face mask as the interface for positive pressure ventilation.<br>Device: T-Piece Resuscitator<br>* T-Piece Resuscitator for providing postivie pressure ventilation via face mask or non-inflatable supraglottic airway<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Spontaneous Breathing | Record of time from beginning of resuscitation to time of spontaneous breathing | 30 minutes | 
| Duration of Positive Pressure Ventilation | Total time of positive pressure ventilation required to adequate spontaneous breathing. | 30 minutes | 
| Need for subsequent endotracheal intubation | Failure of non-invasive resuscitative efforts by face mask or NI-SGA requiring intubation per NRP guideline. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time needed for NI-SGA placement | Time needed adequate placement of non-inflatable supraglottic airway | 1 minute | 
| Need for drugs in resuscitation | Drug administration as part of the standard neonatal resuscitation per NRP | 30 minutes | 
| Use of Chest Compressions | Need for chest compressions as part of neonatal resuscitation per NRP guidelines | 30 minutes | 
| Use of oxygen | Amount and duration of oxygen use in resuscitation | 30 minutes | 
| Rate of complications associated with resuscitation | Presence of complications including bleeding, abdominal distension, laryngeal stridor | 30 minutes | 
| Heart rate 2 minutes after initiation of resuscitation | Heart rate assessed at 2 minutes | 2 minutes | 
| Maximum inspiratory pressure | Record of highest peak inspiratory pressure used in resuscitation | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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supraglottic airway, neonatal resuscitation, ventilation, term infant