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The goal of this single-arm intervention trial is to learn whether using a supraglottic airway (SA) as the primary interface for positive pressure ventilation (PPV) is feasible during delivery room resuscitation of premature infants. This study will be conducted in premature infants born between 29 0/7 and 33 6/7 weeks' gestation who require PPV at birth.
The main question it aims to answer is: Is it feasible to use a supraglottic airway as the primary interface to provide effective PPV during delivery room resuscitation in 29 0/7 to 33 6/7 weeks' gestation premature infants?
Participants will (1)Be screened prenatally and have informed consent obtained from the birth parent prior to delivery; (2)Be rescreened for eligibility on the day of delivery before receiving the study intervention; (3)Receive PPV using a supraglottic airway as the primary ventilation interface if resuscitation is required at birth; and (4)Have clinical and procedural data collected during delivery room resuscitation and for up to 24 hours after birth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supraglottic Airway | Experimental | Premature infants who require positive pressure ventilation immediately after birth will receive ventilation through a supraglottic airway used as the primary airway interface during delivery room resuscitation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supraglottic Airway | Other | Use of a supraglottic airway as the primary interface for delivery of positive pressure ventilation during neonatal resuscitation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Supraglottic Airway as Primary Ventilation Interface | Feasibility defined as successful use of a supraglottic airway as the primary interface to deliver positive pressure ventilation for up to 10 minutes of life or until discontinuation of positive pressure ventilation, without need for immediate escalation to an alternative airway interface. | Immediately after birth (up to 10 minutes of life) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Supraglottic Airway Placement During Resuscitation | Time in minutes from birth to placement of the supraglottic airway as the primary interface for delivery of positive pressure ventilation during delivery room resuscitation. | Immediately after birth |
| Duration of Supraglottic Airway Use During Resuscitation |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate During Resuscitation and First 24 Hours of Life | Heart rate measured in beats per minute (bpm) using continuous cardiorespiratory monitoring during neonatal resuscitation and within the first 24 hours after birth. | Birth to 24 hours of life |
| Oxygen Saturation During Resuscitation and First 24 Hours of Life |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sura Lee | Contact | 215-873-9339 | sura.lee@pennmedicine.upenn.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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Total duration in minutes that the supraglottic airway is used as the primary interface to deliver positive pressure ventilation during delivery room resuscitation. |
| Immediately after birth |
Peripheral oxygen saturation (SpO₂), measured as a percentage using pulse oximetry during neonatal resuscitation and within the first 24 hours after birth. |
| Birth to 24 hours of life |
| Need for Advanced Cardiorespiratory Interventions Within 24 Hours of Birth | Occurrence of cardiorespiratory interventions including endotracheal intubation, chest compressions, administration of epinephrine, or initiation of mechanical ventilation during resuscitation or within the first 24 hours after birth, recorded as yes/no. | Birth to 24 hours of life |