Supraglottic Airway for Resuscitation in Preemies
Respiratory Failure · Premature Neonates · Delivery Room Resuscitation · Positive Pressure Ventilation · Neonatal Resuscitation · Supraglottic Airway · Laryngeal Mask · Laryngeal Mask Airways
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 0 days - 1 days
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 20 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not applicable
- Masking
- No masking
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.
Other: Supraglottic Airway
Supraglottic Airway OTHER
Use of a supraglottic airway as the primary interface for delivery of positive pressure ventilation during neonatal resuscitation.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
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 measures
Time to Supraglottic Airway Placement During Resuscitation
Time frame: Immediately after birth
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.
Duration of Supraglottic Airway Use During Resuscitation
Time frame: Immediately after birth
Total duration in minutes that the supraglottic airway is used as the primary interface to deliver positive pressure ventilation during delivery room resuscitation.
Other measures
Heart Rate During Resuscitation and First 24 Hours of Life
Time frame: Birth to 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.
Oxygen Saturation During Resuscitation and First 24 Hours of Life
Time frame: Birth to 24 hours of life
Peripheral oxygen saturation (SpO₂), measured as a percentage using pulse oximetry during neonatal resuscitation and within the first 24 hours after birth.
Need for Advanced Cardiorespiratory Interventions Within 24 Hours of Birth
Time frame: Birth to 24 hours of life
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.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania, United StatesRecruiting
Study team and timeline
- Lead sponsor
- University of Pennsylvania
- Study start
- Mar 13, 2026 Actual
- Primary completion
- 2027-02 Estimated
- Study completion
- 2027-02 Estimated
- First posted
- Feb 19, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Supraglottic Airway Interface for Positive Pressure Ventilation During Delivery Room Resuscitation of Premature Infants: A Pilot Feasibility Trial
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026