Supraglottic Airway for Resuscitation in Preemies

Purpose

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.

Conditions

  • Respiratory Failure
  • Premature Neonates
  • Delivery Room Resuscitation
  • Positive Pressure Ventilation
  • Neonatal Resuscitation
  • Supraglottic Airway
  • Laryngeal Mask
  • Laryngeal Mask Airways

Eligibility

Eligible Ages
Between 0 Days and 1 Day
Eligible Sex
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Supraglottic Airway
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.
  • Other: Supraglottic Airway
    Use of a supraglottic airway as the primary interface for delivery of positive pressure ventilation during neonatal resuscitation.

Recruiting Locations

Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
Contact:
Sura Lee
215-873-9339
sura.lee@pennmedicine.upenn.edu

More Details

Status
Recruiting
Sponsor
University of Pennsylvania

Study Contact

Sura Lee
215-873-9339
sura.lee@pennmedicine.upenn.edu