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

Withdrawn before enrolling · Not applicable

Conditions studied: Neonatal Resuscitation

In brief

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.

Key facts

Study ID

NCT02629887

Run by

University of Oklahoma

People needed

0

Starts

2018-04-15

Expected to finish

2018-04-15

Last updated by the study team

2018-05-09

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newborns > or = 2000gms requiring positive pressure ventilation within the first 2 minutes of life

You may not qualify if…

• Newborns with expected fetal weight <2000 grams
• Known congenital malformations
• Multiple gestation (twins and above)
• History of meconium stained fluid

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.