Not a traditional drug phase: Supraglottic Airway for Respiratory Failure
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.
Official registry: https://clinicaltrials.gov/study/NCT07419438 · University of Pennsylvania · enrollment listed as 20
What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Supraglottic Airway. The registry lists allocation as na. 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.
They plan to enroll about 20 people at Philadelphia. Taking part typically means study visits and measurements plus check-ins.
Official title (unrewritten)
Supraglottic Airway Interface for Positive Pressure Ventilation During Delivery Room Resuscitation of Premature Infants: A Pilot Feasibility Trial
Interventions: Supraglottic Airway
Primary outcome (registry wording): Feasibility of Supraglottic Airway as Primary Ventilation Interface
Who it is for (from inclusion criteria)
- Ages 0 Days to 1 Day
- Gestational age 29 0/7 to 33 6/7 weeks at birth
- Estimated fetal weight \>/= 1000 grams at birth
- Clinical decision to initiate PPV
Who the registry excludes
- Major anomalies or aneuploidy
- Palliative care planned or considered
- Not resuscitated in the infant resuscitation room
Public study contact (from the registry)
Sura Lee
sura.lee@pennmedicine.upenn.edu
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania (recruiting)
FAQ about this NCT record
Is NCT07419438 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07419438?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07419438?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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