Effective Fraction of Inspired Oxygen With Nasal Cannula in Premature Infants

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03431818

Enrollment

Registered

2018-02-13

Start date

2018-04-04

Completion date

2023-09-07

Last updated

2025-03-20

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

Conditions

Oxygen Therapy

Brief 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).

Detailed 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).

Interventions

OTHERNasal 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.

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

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