- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05609773
Comparing Intubation Rates in the Delivery Room by Interface
December 15, 2022 updated by: University of Illinois College of Medicine at Peoria
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
42
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ashley Fischer, MD
- Phone Number: 309-624-8977
- Email: Ashley.M.Fischer2@osfhealthcare.org
Study Locations
-
-
Illinois
-
Peoria, Illinois, United States, 61604
- Recruiting
- University of Illinois College of Medicince
-
Contact:
- Ashley Fischer, MD
- Phone Number: 309-624-9602
- Email: Ashley.M.Fischer2@osfhealthcare.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 8 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All resuscitated infants < 30 weeks' gestation born at OSF SFMC.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparing Intubation Rates in the Delivery Room by Interface
Time Frame: 3 years
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ashley Fischer, MD, University of Illinois College of Medicine at Peoria
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 22, 2022
Primary Completion (Anticipated)
September 22, 2025
Study Completion (Anticipated)
September 22, 2025
Study Registration Dates
First Submitted
October 31, 2022
First Submitted That Met QC Criteria
November 4, 2022
First Posted (Actual)
November 8, 2022
Study Record Updates
Last Update Posted (Actual)
December 20, 2022
Last Update Submitted That Met QC Criteria
December 15, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1783154
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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