NCT07419438 · University of Pennsylvania
Supraglottic Airway for Resuscitation in Preemies
(SUPREEMIE)
What this study is about
The goal of this single-treatment group$1 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.
View original scientific description
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.
Interventions
OTHER
Supraglottic Airway
Use of a supraglottic airway as the primary interface for delivery of positive pressure ventilation during neonatal resuscitation.
Primary outcome 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether 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
Where
- Philadelphia, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 14, 2026 · Source of record for eligibility and locations