Supraglottic Airway for Premature Babies
(SUPREEMIE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of a supraglottic airway (a type of breathing tube) in helping premature babies breathe immediately after birth. It focuses on babies born between 29 and 33 weeks who require breathing assistance. The trial seeks to determine if this method is effective during the critical moments following birth. Babies needing breathing support at birth and meeting the gestational age criteria may be suitable candidates for this trial. As an unphased trial, it provides a unique opportunity to contribute to important research that could enhance breathing support for premature babies.
What prior data suggests that using a supraglottic airway for premature infants is safe?
Research has shown that supraglottic airways (SGAs) are generally safe and effective for newborns needing breathing assistance. These devices, positioned above the voice box, are easy to use and safe for newborns requiring support. A national resuscitation registry report, which included 281 infants, also supported the use of SGAs in newborn resuscitation.
For younger infants, including those under two months old, SGAs have proven to be a safe and effective method for breathing assistance. These findings suggest that SGAs are well-tolerated in newborns, even those born prematurely. While more research is needed, current evidence supports the safety of using supraglottic airways in these vulnerable infants.12345Why are researchers excited about this trial?
Unlike the standard of care, which usually involves endotracheal intubation or bag-mask ventilation for premature babies needing immediate breathing support, the supraglottic airway offers a novel approach. This treatment is unique because it uses a specialized device placed above the vocal cords to deliver ventilation, potentially simplifying the process of providing positive pressure ventilation. Researchers are excited about this technique because it could make resuscitation quicker and less invasive, reducing the risk of trauma and complications associated with traditional methods. This innovation might streamline emergency care in the delivery room, making it a promising option for improving outcomes in these vulnerable infants.
What evidence suggests that using a supraglottic airway is effective for resuscitating premature infants?
Research has shown that certain devices called supraglottic airways (SGAs) effectively help newborns breathe. Studies indicate that SGAs can outperform traditional facemasks in newborn resuscitation. They have successfully assisted newborns, including those born prematurely, in obtaining sufficient oxygen and breathing properly. Additionally, SGAs have reduced the need for more invasive procedures, such as inserting a tube into the windpipe, in full-term newborns. In this trial, premature infants requiring positive pressure ventilation immediately after birth will receive ventilation through a supraglottic airway, suggesting that SGAs could be a promising option for helping premature babies breathe right after birth.14678
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive positive pressure ventilation using a supraglottic airway during delivery room resuscitation
Follow-up
Participants are monitored for clinical and procedural data collection during delivery room resuscitation and for up to 24 hours after birth
What Are the Treatments Tested in This Trial?
Interventions
- Supraglottic Airway
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor
Citations
Preterm Supraglottic Airways Succeed in Neonatal ... - PMC
SADs have proven effective for achieving PPV in term neonates, potentially reducing the need for ETI. International Neonatal Resuscitation ...
Surfactant Therapy Via Supraglottic Airway to Preterm ...
The study will include preterm babies born before 34 weeks of pregnancy and weighing at least 750 grams, at Phu San Hanoi Hospital in Vietnam. If SALSA is found ...
Use of supraglottic airways in neonates and infants less ...
Oxygenation and ventilation via SGA were successful in four of these cases, facilitating return of spontaneous circulation, including in two preterm neonates ...
Preterm Supraglottic Airways Succeed in Neonatal ...
Conclusion: Preterm-sized supraglottic airway devices appeared feasible for simulated neonatal resuscitation. Further clinical studies are ...
Comparison of supraglottic airway device and ...
We aim to compare the perioperative respiratory adverse events between using supraglottic airway device (SAD) and ETT in former preterm infants receiving ...
Supraglottic airway use during neonatal resuscitation
A recent publication reporting outcomes for infants included in a national resuscitation registry included 281 infants receiving a first dose of ...
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www2.pedsanesthesia.org
www2.pedsanesthesia.org/meetings/2025winter/guide/posters/uploads/418--AIR1-9.pdfSupraglottic airway use in neonates and young infants
1. SGAs would be infrequently used among patients under 2 months of age. 2. SGAs would be a safe, efficacious airway management ...
Preterm Supraglottic Airways Succeed in Neonatal ...
This study aimed to evaluate ventilation outcomes in manikins to determine whether progression to clinical testing is warranted. Methods. This ...
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