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

May 3, 2018 updated by: University of Oklahoma

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73117
        • University of Oklahoma Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 30 minutes (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Face Mask
Standard Face Mask with T piece resuscitator for neonatal resuscitation. Face mask placement per Neonatal Resuscitation Program resuscitation guideline.
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
Active Comparator: Non-inflatable supraglottic airway
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.
Device: T-Piece Resuscitator
T-Piece Resuscitator for providing postivie pressure ventilation via face mask or non-inflatable supraglottic airway
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Spontaneous Breathing
Time Frame: 30 minutes
Record of time from beginning of resuscitation to time of spontaneous breathing
30 minutes
Duration of Positive Pressure Ventilation
Time Frame: 30 minutes
Total time of positive pressure ventilation required to adequate spontaneous breathing.
30 minutes
Need for subsequent endotracheal intubation
Time Frame: 30 minutes
Failure of non-invasive resuscitative efforts by face mask or NI-SGA requiring intubation per NRP guideline.
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time needed for NI-SGA placement
Time Frame: 1 minute
Time needed adequate placement of non-inflatable supraglottic airway
1 minute
Need for drugs in resuscitation
Time Frame: 30 minutes
Drug administration as part of the standard neonatal resuscitation per NRP
30 minutes
Use of Chest Compressions
Time Frame: 30 minutes
Need for chest compressions as part of neonatal resuscitation per NRP guidelines
30 minutes
Use of oxygen
Time Frame: 30 minutes
Amount and duration of oxygen use in resuscitation
30 minutes
Rate of complications associated with resuscitation
Time Frame: 30 minutes
Presence of complications including bleeding, abdominal distension, laryngeal stridor
30 minutes
Heart rate 2 minutes after initiation of resuscitation
Time Frame: 2 minutes
Heart rate assessed at 2 minutes
2 minutes
Maximum inspiratory pressure
Time Frame: 30 minutes
Record of highest peak inspiratory pressure used in resuscitation
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Investigators

  • Principal Investigator: Arlen Foulks, DO, University of Oklahoma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 15, 2018

Primary Completion (Anticipated)

April 15, 2018

Study Completion (Anticipated)

April 15, 2018

Study Registration Dates

First Submitted

December 10, 2015

First Submitted That Met QC Criteria

December 10, 2015

First Posted (Estimate)

December 14, 2015

Study Record Updates

Last Update Posted (Actual)

May 9, 2018

Last Update Submitted That Met QC Criteria

May 3, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 5848

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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