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Comparing Intubation Rates in the Delivery Room by Interface

Comparing Intubation Rates in the Delivery Room by Interface

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05609773
Enrollment
42
Registered
2022-11-08
Start date
2022-09-22
Completion date
2025-09-22
Last updated
2022-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator Lung; Newborn

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.

Interventions

None listed

Sponsors

Children's Hospital of Illinois
CollaboratorUNKNOWN
OSF Healthcare System
CollaboratorOTHER
University of Illinois College of Medicine at Peoria
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Weeks to 30 Weeks
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Comparing Intubation Rates in the Delivery Room by Interface3 yearsWe 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.

Countries

United States

Contacts

Primary ContactAshley Fischer, MD
Ashley.M.Fischer2@osfhealthcare.org309-624-8977

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026