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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.