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Completed

NCT Number: NCT03431818

Effective Fraction of Inspired Oxygen With Nasal Cannula in Premature Infants

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).

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Key information

Conditions

Oxygen Therapy

Sex eligibility

All sexes

Study type

Observational

Primary location

NICU at Holtz Children's Hospital

Miami, Florida, 33136, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nasal cannula flow rate

Other

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.

Primary outcomes

  1. Nasal cannula FiO2

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Feb 13, 2018
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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