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Recruiting Not applicable NCT07419438

Supraglottic Airway for Resuscitation in Preemies

No applicable phase (e.g. observational)
Conditions: Respiratory Failure Premature Neonates Delivery Room Resuscitation Positive Pressure Ventilation Neonatal Resuscitation Supraglottic Airway Laryngeal Mask Laryngeal Mask Airways

Sponsor: University of Pennsylvania

trial.available_in: БГ
Overview
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.
Who can participate
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
Interventions
Supraglottic Airway
OTHER
Locations 1
United States (1)
Hospital of the University of Pennsylvania
Philadelphia , Pennsylvania
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
0 Days
Maximum age
1 Day
Healthy volunteers
No
Start date
13.03.2026
Completion date
01.10.2026
Registry ID
NCT07419438
Source
clinicaltrials.gov
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