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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05609773
Other study ID # 1783154
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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