Supraglottic Airway Interface for Positive Pressure Ventilation During Delivery Room Resuscitation of Premature Infants: A Pilot Feasibility Trial
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Pennsylvania
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Feasibility of Supraglottic Airway as Primary Ventilation Interface
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 0 Days to 1 Day (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Gestational age 29 0/7 to 33 6/7 weeks at birth
- •Estimated fetal weight \>/= 1000 grams at birth
- •Clinical decision to initiate PPV
- •Parental informed consent
Exclusion Criteria
- •Major anomalies or aneuploidy
- •Palliative care planned or considered
- •Not resuscitated in the infant resuscitation room
Arms & Interventions
Supraglottic Airway
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.
Intervention: Supraglottic Airway (Other)
Outcomes
Primary Outcomes
Feasibility of Supraglottic Airway as Primary Ventilation Interface
Time Frame: Immediately after birth (up to 10 minutes of life)
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.
Secondary Outcomes
- Time to Supraglottic Airway Placement During Resuscitation(Immediately after birth)
- Duration of Supraglottic Airway Use During Resuscitation(Immediately after birth)