WithdrawnNot Applicable

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

Stopped: Study design changed for recruitment purposes; no participants enrolled

United States0Started 2018-04-15

Plain-language 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.

Who can participate

Age range30 Minutes

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Time to Spontaneous Breathing

Timeframe: 30 minutes

Duration of Positive Pressure Ventilation

Timeframe: 30 minutes

Need for subsequent endotracheal intubation

Timeframe: 30 minutes

Trial details

NCT IDNCT02629887

SponsorUniversity of Oklahoma

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-04-15

View on ClinicalTrials.gov More Neonatal Resuscitation trials