Non-inflatable Supraglottic Airway (NI-SGA) vs. Face Mask (FM) as a Primary Interface Device for Neonatal Resuscitation

University of Oklahoma (OU)

Status: Withdrawn

Conditions: Neonatal Resuscitation

Treatments: Device: T-Piece Resuscitator; Device: Non-inflatable supraglottic airway; Device: Face Mask

Study type: Interventional

Funder types: Other

Identifiers

NCT02629887

5848

Details and patient eligibility

About

Prospective, randomized controlled trial to be performed at one center, of term and late preterm infants requiring resuscitation. Prenatal consent will be obtained. At randomization, babies will be resuscitated following Neonatal Resuscitation Program (NRP) guidelines and ventilated using the T-piece resuscitator with either a Face Mask (FM) or Non-inflating supraglottic airway. Video will be collected during resuscitation as well as written documentation. Primary outcome will be time to spontaneous breathing, length of resuscitation, and need for endotracheal intubation.

Full description

Mothers who are close to delivery of a term or near term infant with estimated fetal weight of 2500gms will be approached for consent to randomize their infant to resuscitation with mask or non-inflatable supraglottic airway (NISGA) if resuscitation is required. Study personnel in delivery will open sequential envelopes with randomized code to indicate which device is to be used if necessary. The resuscitator will be blinded until determination of need of respiratory support. At that time, the appropriate randomized device (face mask or NISGA) will be handed to the resuscitator for use along with T-Piece resuscitator. Video data capture will be used to record type, length and response to resuscitation. This information will be translated to a database prior to destruction of video.

Sex: All

Ages: Under 30 minutes old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newborns > or = 2000gms requiring positive pressure ventilation within the first 2 minutes of life

Exclusion criteria

• Newborns with expected fetal weight <2000 grams
• Known congenital malformations
• Multiple gestation (twins and above)
• History of meconium stained fluid

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Face Mask

Active Comparator group

Description:

Standard Face Mask with T piece resuscitator for neonatal resuscitation. Face mask placement per Neonatal Resuscitation Program resuscitation guideline.

Treatment:

Device: Face Mask

Device: T-Piece Resuscitator

Non-inflatable supraglottic airway

Active Comparator group

Description:

Use of non-inflating supraglottic airway with T-piece resuscitator instead of Standard Face Mask with T piece resuscitator for neonatal resuscitation, replacing standard of care face mask in Neonatal Resuscitation Program guideline.

Treatment:

Device: T-Piece Resuscitator

Device: Non-inflatable supraglottic airway