Recruiting

Observational Study

Sponsor:

University of Illinois College of Medicine at Peoria

Code:

NCT05609773

Conditions

Ventilator Lung; Newborn

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Ventilator Lung; Newborn

Study ID

NCT05609773

Start date

Sep 22, 2022

Status verified date

Nov, 2022

Completion date

Sep 22, 2025

Anticipated

Primary completion date

Sep 22, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Enrollment

42 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Comparing Intubation Rates in the Delivery Room by Interface [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Locations

University of Illinois College of Medicince

Recruiting

Peoria, Illinois, United States, 61604

Contacts

More Information

Sponsor

University of Illinois College of Medicine at Peoria

Last update posted

Dec 20, 2022

Last verified

Nov, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Illinois College of Medicine at Peoria on 2022-12-20.