Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT02629887
Study type Interventional
Source University of Oklahoma
Contact
Status Withdrawn
Phase N/A
Start date April 15, 2018
Completion date April 15, 2018

See also
  Status Clinical Trial Phase
Completed NCT04076189 - Time of Positive Pressure Ventilation in Non-vigorous Infants Born Through Meconium-stained Amniotic Fluid N/A
Not yet recruiting NCT03660033 - ECG Monitoring During NRP: a False Sense of Security? N/A
Completed NCT03730025 - Impact of a Mobile Application for Heart Rate Assessment in Simulated Neonatal Resuscitation N/A
Recruiting NCT04056091 - Back Rubs or Foot Flicks for Neonatal Stimulation at Birth in a Low-resource Setting N/A
Terminated NCT03885492 - The Baby-Saver Kit: Clinical Testing of a Device for Neonatal Resuscitation With Intact Cord in Uganda
Completed NCT01869582 - Safer Births - Reducing Perinatal Mortality N/A
Recruiting NCT06258187 - Pedi-Cap CO2 Detector for Face-mask Ventilation in the Delivery Room N/A
Completed NCT03133663 - Heart Rate Evaluation and Resuscitation Trial in Preterm Neonates N/A
Completed NCT03799861 - Newborn Heart Rate as a Catalyst for Improved Survival
Completed NCT05472155 - SUCTIONING AT BIRTH WITH BULB SYRINGE OR SUCTION CATHETER: A RANDOMIZED CONTROLLED TRIAL N/A
Recruiting NCT01963936 - Supreme-LMA for Neonatal Resuscitation: a Prospective, Randomized Single-center Study Phase 3
Completed NCT03844009 - Computer Debriefing and Screen-based Simulation N/A
Completed NCT04242654 - Doppler Ultrasound Compared With Stethoscope to Assess Heart Rate (HR) N/A
Completed NCT02840682 - Outcomes of Neonatal Resuscitation N/A