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NCT Number: NCT07419438

Supraglottic Airway for Resuscitation in Preemies

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.

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Key information

Conditions

Respiratory Failure Delivery Room Resuscitation Laryngeal Mask Laryngeal Mask Airways Neonatal Resuscitation Positive Pressure Ventilation Premature Neonates Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Supraglottic Airway

Age range

0 day–1 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Sura Lee

CONTACT

[email protected]

215-873-9339

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 and study plan

Supraglottic Airway

Other

Use of a supraglottic airway as the primary interface for delivery of positive pressure ventilation during neonatal resuscitation.

Primary outcomes

  1. 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

  1. 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.

  2. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sura Lee

CONTACT

[email protected]

215-873-9339

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Supraglottic Airway Interface for Positive Pressure Ventilation During Delivery Room Resuscitation of Premature Infants: A Pilot Feasibility Trial

Acronym: SUPREEMIE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 19, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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