Supraglottic Airway for Resuscitation in Preemies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Supraglottic Airway.
- Who it may be relevant to
- Registry conditions: Respiratory Failure, Premature Neonates, Delivery Room Resuscitation, Positive Pressure Ventilation. Basic parameters: 0 Days — 1 Day · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Supraglottic Airway Interface for Positive Pressure Ventilation During Delivery Room Resuscitation of Premature Infants: A Pilot Feasibility Trial
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.
Interventions
- Other Supraglottic Airway
Use of a supraglottic airway as the primary interface for delivery of positive pressure ventilation during neonatal resuscitation.
Primary outcome measures
- Feasibility of Supraglottic Airway as Primary Ventilation Interface [Time frame: Immediately after birth (up to 10 minutes of life)]
Secondary outcome measures (2)
- Time to Supraglottic Airway Placement During Resuscitation [Time frame: Immediately after birth]
- Duration of Supraglottic Airway Use During Resuscitation [Time frame: Immediately after birth]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Hospital of the University of Pennsylvania — Philadelphia
Identifiers
NCT: NCT07419438 · 857967