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

Not Applicable

Withdrawn

• Conditions: Neonatal Resuscitation
• Interventions: Device: Face Mask; Device: Non-inflatable supraglottic airway; Device: T-Piece Resuscitator

• Registration Number: NCT02629887
• Lead Sponsor: University of Oklahoma

Brief 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.

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 Timeline

• Study First Submitted: 2015-12-10
• Study First Submitted QC: 2015-12-10
• Study First Posted: 2015-12-14
• Study Start: 2018-04-15
• Primary Completion: 2018-04-15
• Study Completion: 2018-04-15
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-03
• Last Update Posted: 2018-05-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-inflatable supraglottic airway	T-Piece Resuscitator	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.
Face Mask	Face Mask	Standard Face Mask with T piece resuscitator for neonatal resuscitation. Face mask placement per Neonatal Resuscitation Program resuscitation guideline.
Non-inflatable supraglottic airway	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.
Face Mask	T-Piece Resuscitator	Standard Face Mask with T piece resuscitator for neonatal resuscitation. Face mask placement per Neonatal Resuscitation Program resuscitation guideline.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States