Supraglottic airway to support breathing in premature infants born at 29–33 weeks
Supraglottic Airway Interface for Positive Pressure Ventilation During Delivery Room Resuscitation of Premature Infants: A Pilot Feasibility Trial
NA · University of Pennsylvania · NCT07419438
We will try using a supraglottic airway to give positive-pressure breaths right after birth to premature infants born at 29 0/7–33 6/7 weeks who need help breathing.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 0 Days to 1 Day |
| Sex | All |
| Sponsor | University of Pennsylvania (other) |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT07419438 on ClinicalTrials.gov |
What this trial studies
This single-arm feasibility trial will enroll infants born at 29 0/7 to 33 6/7 weeks' gestation who require positive-pressure ventilation (PPV) at delivery. Prenatal consent will be obtained and eligibility will be reconfirmed at the time of delivery. If resuscitation is required, a supraglottic airway (SA) will be used as the primary interface for PPV and clinical and procedural data will be collected during delivery-room resuscitation. The goal is to determine whether using an SA is practical and can provide effective ventilation in this preterm population.
Who should consider this trial
Good fit: Premature infants born at 29 0/7 to 33 6/7 weeks' gestation with estimated birth weight ≥1000 g whose care team decides PPV is needed at birth and whose parent provided prenatal consent.
Not a fit: Extremely preterm infants (<29 weeks), babies with major congenital anomalies or aneuploidy, infants planned for palliative care, or those not resuscitated in the designated resuscitation room are unlikely to receive benefit from this approach.
Why it matters
Potential benefit: If successful, this approach could make initial breathing support easier and faster for moderate preterm infants and reduce the need for emergency intubation.
How similar studies have performed: Supraglottic airways have shown promise in term newborns and simulation studies, but routine use specifically for resuscitation of 29–33 week preterm infants is largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Philadelphia, Pennsylvania
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
Study contacts
- Study coordinator: Sura Lee
- Email: sura.lee@pennmedicine.upenn.edu
- Phone: 215-873-9339
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Respiratory Failure, Premature Neonates, Delivery Room Resuscitation, Positive Pressure Ventilation, Neonatal Resuscitation, Supraglottic Airway, Laryngeal Mask, Laryngeal Mask Airways