Effective Fraction of Inspired Oxygen With Nasal Cannula in Premature Infants

NCT ID: NCT03431818

Last Updated: 2025-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-04

Study Completion Date

2023-09-07

Brief Summary

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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

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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).

Conditions

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Oxygen Therapy

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Nelson Claure

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nelson Claure

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Eduardo Bancalari

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Deepak Jain

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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NICU at Holtz Children's Hospital

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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20170816

Identifier Type: -

Identifier Source: org_study_id

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