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NCT03431818 Clinical Trial

Effective Fraction of Inspired Oxygen With Nasal Cannula in Premature Infants

Oxygen Therapy Clinical Trial

Official title:
Effective Fraction of Inspired Oxygen in Premature Infants Receiving Support Via Nasal Cannula

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03431818
Other study ID # 20170816
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 4, 2018
Est. completion date September 7, 2023

Study information
Verified date April 2024
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The objective of this study is to determine the multifactorial relationship between the effective fraction of inspired oxygen (Effective-FiO2) and the FiO2 in the gas delivered by the nasal cannula (NC-FiO2), NC flow rate, spontaneous minute ventilation and other patient characteristics in premature infants who receive supplemental oxygen via nasal cannula (NC).

Description:

During routine nasal cannula (NC) use in the newborn ICU, the actual fraction of oxygen inspired by the infant, i.e. the effective FiO2 (Effective-FiO2) that reaches the infant's airways, cannot be easily determined. The effective FiO2 during NC use is generally lower than the FiO2 in the gas delivered by NC at the infant's nose due to dilution with ambient gas entrained by the infants during spontaneous inspiration. The factors influencing effective FiO2 include the set FiO2 of the gas delivered by NC (NC-FiO2), the NC-flow rate, and the entrainment of ambient gas by the infant during each spontaneous inspiration. The individual contribution of each of these factors to the variability in effective-FiO2 in extreme premature infants has not been systematically evaluated. The objective of this study is to determine the multifactorial relationship between the effective fraction of inspired oxygen (Effective-FiO2) and the FiO2 in the gas delivered by the nasal cannula (NC-FiO2), NC flow rate, spontaneous minute ventilation and other patient characteristics in premature infants who receive supplemental oxygen via nasal cannula (NC).

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date September 7, 2023
Est. primary completion date September 7, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Premature infants born between 23 and 30 weeks of gestational age - Receiving supplemental oxygen via nasal cannula - Parental informed consent Exclusion Criteria: - Major congenital anomalies - Clinically unstable

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Nasal cannula flow rate
This is a crossover study where observations will be obtained at five nasal cannula flow rates: 0.5, 1, 2, 4 and 6 liters per minute.

Locations
Country Name City State
United States NICU at Holtz Children's Hospital Miami Florida

Sponsors (1)
Lead Sponsor Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Nasal cannula FiO2 FiO2 necessary to maintain the effective FiO2 (measured at the hypopharynx) at the basal level at different nasal cannula flow rates. from birth upto 40 weeks corrected postmenstrual age
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