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

NCT02629887 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-05-09

No results posted yet for this study

Summary

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.

Conditions

  • Neonatal Resuscitation

Interventions

DEVICE

Non-inflatable supraglottic airway

at delivery if resuscitation is required infant randomized to NI-SGA or face mask as the interface for positive pressure ventilation.

DEVICE

Face Mask

at delivery - standard airway management per Neonatal Resuscitation Program utilizing face mask.

DEVICE

T-Piece Resuscitator

T-Piece Resuscitator for providing postivie pressure ventilation via face mask or non-inflatable supraglottic airway

Sponsors & Collaborators

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Arlen Foulks, DO · University of Oklahoma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
30 Minutes
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-15
Primary Completion
2018-04-15
Completion
2018-04-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02629887 on ClinicalTrials.gov