Effective Fraction of Inspired Oxygen With Nasal Cannula in Premature Infants

Last updated: March 17, 2025
Sponsor: University of Miami
Overall Status: Completed

Phase

N/A

Condition

Transdermal Continuous Oxygen Therapy (Tcot)

Treatment

Nasal cannula flow rate

Clinical Study ID

NCT03431818
20170816
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Premature infants born between 23 and 30 weeks of gestational age

  • Receiving supplemental oxygen via nasal cannula

  • Parental informed consent

Exclusion

Exclusion Criteria:

  • Major congenital anomalies

  • Clinically unstable

Study Design

Total Participants: 35
Treatment Group(s): 1
Primary Treatment: Nasal cannula flow rate
Phase:
Study Start date:
April 04, 2018
Estimated Completion Date:
September 07, 2023

Study 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).

Connect with a study center

  • NICU at Holtz Children's Hospital

    Miami, Florida 33136
    United States

    Site Not Available

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