Clinical trial NCT02629887: Non-inflatable Supraglottic Airway (NI-SGA) vs. Face Mask (FM) as a Primary Interface Device for Neonatal Resuscitation
Official title: Non-inflatable Supraglottic Airway (NI-SGA) vs. Face Mask (FM) as a Primary Interface Device for Neonatal Resuscitation: A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Neonatal Resuscitation
Keywords: supraglottic airway
neonatal resuscitation
ventilation
term infant
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2015-12-14
Enrollment: 0
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to Spontaneous Breathing
timeFrame: 30 minutes
measure: Duration of Positive Pressure Ventilation
timeFrame: 30 minutes
measure: Need for subsequent endotracheal intubation
timeFrame: 30 minutes
Secondary outcomes:
measure: Time needed for NI-SGA placement
timeFrame: 1 minute
measure: Need for drugs in resuscitation
timeFrame: 30 minutes
measure: Use of Chest Compressions
timeFrame: 30 minutes
measure: Use of oxygen
timeFrame: 30 minutes
measure: Rate of complications associated with resuscitation
timeFrame: 30 minutes
measure: Heart rate 2 minutes after initiation of resuscitation
timeFrame: 2 minutes
measure: Maximum inspiratory pressure
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Arlen Foulks, DO
role: PRINCIPAL_INVESTIGATOR
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