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Clinical Trials/NCT05609773
NCT05609773
Recruiting
Not Applicable

Comparing Intubation Rates in the Delivery Room by Interface

University of Illinois College of Medicine at Peoria1 site in 1 country42 target enrollmentSeptember 22, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ventilator Lung; Newborn
Sponsor
University of Illinois College of Medicine at Peoria
Enrollment
42
Locations
1
Primary Endpoint
Comparing Intubation Rates in the Delivery Room by Interface
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

Although the majority of premature neonates < 30 weeks gestion require positive pressure ventilation (PPV) at birth, the optimal interface to provide PPV has not been determined. Preferably this support would be provided by non-invasive means to prevent the development of bronchopulmonary dysplasia. Resuscitation with a face mask, single nasal tube, nasal prongs, and/or LMA are all approved methods of resuscitation per NRP as of 2010. Face masks have been associated with more dead space, air leak and airway obstruction however are the most commonly used interface. Recently, the Trigeminal Cardiac Reflex has been described, which can be induced with the placement of a facemask, resulting in bradycardia and apnea. Bi-nasal prongs (RAM cannula) have been found in studies to be associated with lower intubation rates in the delivery room (down to 24 weeks gestation), less need for epinephrine, chest compressions, and subsequent invasive ventilation. In addition to the potential practical advantages of bi-nasal prong resuscitation, there is evidence to suggest that ventilation through the nose may stimulate the subepithelial receptors of the upper airways causing an increase in respiratory rate and depth.

Registry
clinicaltrials.gov
Start Date
September 22, 2022
End Date
September 22, 2025
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Illinois College of Medicine at Peoria
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • All resuscitated infants \< 30 weeks' gestation born at OSF SFMC

Exclusion Criteria

  • Diagnosis of congenital diaphragmatic hernia No PPV needed, or no resuscitation desired due to major congenital anomalies or peri- viable status

Outcomes

Primary Outcomes

Comparing Intubation Rates in the Delivery Room by Interface

Time Frame: 3 years

We hypothesize that there will be at least a 40% reduction in the rate of intubation for patients born \< 30 weeks' gestation when bi-nasal prongs are utilized for neonatal resuscitation vs face mask.

Study Sites (1)

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