Supraglottic Airway for Resuscitation in Preemies

N/ARecruitingNCT07419438

University of Pennsylvania20 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Respiratory Failure Premature Neonates Delivery Room Resuscitation

Eligibility

Sex: ALLMin age: 0 DaysMax age: 1 Day

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Feasibility of Supraglottic Airway as Primary Ventilation Interface

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.

Time frame: Immediately after birth (up to 10 minutes of life)

Secondary Outcomes

Time to Supraglottic Airway Placement During Resuscitation

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.

Time frame: Immediately after birth

Duration of Supraglottic Airway Use During Resuscitation

Total duration in minutes that the supraglottic airway is used as the primary interface to deliver positive pressure ventilation during delivery room resuscitation.