Comparing Intubation Rates in the Delivery Room by Interface

Recruiting

• Conditions: Ventilator Lung; Newborn

• Registration Number: NCT05609773
• Lead Sponsor: University of Illinois College of Medicine at Peoria

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-22
• Study First Submitted: 2022-10-31
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-04
• Study First Posted: 2022-11-08
• Last Update Submitted: 2022-12-15
• Last Update Posted: 2022-12-20
• Primary Completion: 2025-09-22
• Study Completion: 2025-09-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparing Intubation Rates in the Delivery Room by Interface	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.

Trial Locations

Locations (1)

University of Illinois College of Medicince; 🇺🇸 Peoria, Illinois, United States