Comparing Intubation Rates in the Delivery Room by Interface

Ventilator Lung; Newborn Clinical Trial

Official title:

Comparing Intubation Rates in the Delivery Room by Interface

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05609773
• Other study ID #: 1783154
• Status: Recruiting
• Start date: September 22, 2022
• Est. completion date: September 22, 2025

Study information

• Verified date: November 2022
• Source: University of Illinois College of Medicine at Peoria
• Contact: Ashley Fischer, MD
• Phone: 309-624-8977
• Email: Ashley.M.Fischer2[@]osfhealthcare.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: September 22, 2025
• Est. primary completion date: September 22, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Weeks to 30 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Ventilator Lung; Newborn

Locations

Country	Name	City	State
United States	University of Illinois College of Medicince	Peoria	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
University of Illinois College of Medicine at Peoria	Children's Hospital of Illinois, OSF Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparing Intubation Rates in the Delivery Room by Interface	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.	3 years