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Comparing Intubation Rates in the Delivery Room by Interface

NCT ID: NCT05609773

Last Updated: 2022-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-22

Study Completion Date

2025-09-22

Brief Summary

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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

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Conditions

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Ventilator Lung; Newborn

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

0 Weeks

Maximum Eligible Age

30 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Illinois

UNKNOWN

Sponsor Role collaborator

OSF Healthcare System

OTHER

Sponsor Role collaborator

University of Illinois College of Medicine at Peoria

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ashley Fischer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois College of Medicine at Peoria

Locations

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University of Illinois College of Medicince

Peoria, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ashley Fischer, MD

Role: CONTACT

Phone: 309-624-8977

Email: [email protected]

Facility Contacts

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Ashley Fischer, MD

Role: primary

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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1783154

Identifier Type: -

Identifier Source: org_study_id