Delivery Room Resuscitation, Laryngeal Mask, Laryngeal Mask Airways, Neonatal Resuscitation, Positive Pressure Ventilation, Premature Neonates, Respiratory Failure, Supraglottic Airway
Conditions
Keywords
Respiratory failure, Premature neonates, Delivery Room Resuscitation, Positive pressure ventilation, Neonatal resuscitation, Supraglottic Airway, laryngeal mask, Laryngeal Mask Airways
Brief summary
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
OTHERSupraglottic Airway
Use of a supraglottic airway as the primary interface for delivery of positive pressure ventilation during neonatal resuscitation.
Sponsors
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Days to 1 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Supraglottic Airway as Primary Ventilation Interface | 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
| Measure | Time frame | Description |
|---|---|---|
| Time to Supraglottic Airway Placement During Resuscitation | 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. |
| Duration of Supraglottic Airway Use During Resuscitation | 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. |
Countries
United States
Contacts
CONTACTSura Lee
Outcome results
None listed