Respiratory FailureSUPREEMIENCT07419438
Supraglottic Airway for Resuscitation in Preemies
A study testing Supraglottic Airway in people with Respiratory Failure and Premature Neonates, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 days to 1 day
- Conditions the study is for
- Respiratory Failure, Premature Neonates, Delivery Room Resuscitation
- What is being tested?
- Supraglottic Airway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2026to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 1 day
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Major anomalies or aneuploidy
- Palliative care planned or considered
- Not resuscitated in the infant resuscitation room
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Sura Lee, 215-873-9339, sura.lee@pennmedicine.upenn.edu
About this study
Official title: Supraglottic Airway Interface for Positive Pressure Ventilation During Delivery Room Resuscitation of Premature Infants: A Pilot Feasibility Trial
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.
- Conditions
- Respiratory Failure, Premature Neonates, Delivery Room Resuscitation, Positive Pressure Ventilation, Neonatal Resuscitation, Supraglottic Airway
- Being tested
- Supraglottic Airway
- Keywords
- Respiratory failure, Premature neonates, Delivery Room Resuscitation, Positive pressure ventilation, Neonatal resuscitation, Supraglottic Airway, laryngeal mask, Laryngeal Mask Airways
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supraglottic AirwayOther
Use of a supraglottic airway as the primary interface for delivery of positive pressure ventilation during neonatal resuscitation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Supraglottic Airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after birth (up to 10 minutes of life)
Secondary outcomes (2)
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.
Measured: Immediately after birth
Duration of Supraglottic Airway Use During Resuscitation
Total duration in minutes that the supraglottic airway is used as the primary interface to deliver positive pressure ventilation during delivery room resuscitation.
Measured: Immediately after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start13 Mar 2026
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419438
- Sponsor's protocol ID
- 857967
- Acronym
- SUPREEMIE
- Status last verified
- Jul 2026
- First submitted
- 5 Jan 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supraglottic Airway Interface for Positive Pressure Ventilation During Delivery Room Resuscitation of Premature Infants: A Pilot Feasibility Trial
- ClinicalTrials.gov ID
- NCT07419438
- Acronym / sponsor ID
- SUPREEMIE / 857967
- Conditions
- Respiratory Failure, Premature Neonates, Delivery Room Resuscitation, Positive Pressure Ventilation, Neonatal Resuscitation, Supraglottic Airway
- Keywords
- Respiratory failure, Premature neonates, Delivery Room Resuscitation, Positive pressure ventilation, Neonatal resuscitation, Supraglottic Airway, laryngeal mask, Laryngeal Mask Airways
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 13 Mar 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supraglottic Airway | Experimental | Other: Supraglottic AirwayPremature 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. |
Who may qualify
- Ages
- 0 days to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Major anomalies or aneuploidy
- Palliative care planned or considered
- Not resuscitated in the infant resuscitation room
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supraglottic AirwayUse of a supraglottic airway as the primary interface for delivery of positive pressure ventilation during neonatal resuscitation. | Other | Supraglottic Airway |
Primary outcome
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.
2 secondary outcomes
Time to Supraglottic Airway Placement During Resuscitation
Time frame: Immediately after birth
Duration of Supraglottic Airway Use During Resuscitation
Time frame: Immediately after birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supraglottic Airway in people with Respiratory Failure and Premature Neonates, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sura Lee (215-873-9339, sura.lee@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Supraglottic Airway as Primary Ventilation Interface (time frame: Immediately after birth (up to 10 minutes of life)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.