Oxygen TherapyNCT03431818
Effective Fraction of Inspired Oxygen With Nasal Cannula in Premature Infants
An observational study of Oxygen Therapy, run by University of Miami at 1 site in United States.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oxygen Therapy
- What is being tested?
- Nasal cannula flow rate
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2018to 7 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Premature infants admitted to the newborn ICU will be screened. Infants who meet the inclusion criteria will be enrolled in the study after written informed parental consent is obtained:
Who may be able to join
- Premature infants born between 23 and 30 weeks of gestational age
- Receiving supplemental oxygen via nasal cannula
- Parental informed consent
Who cannot join
- Major congenital anomalies
- Clinically unstable
Trial locations and contacts
1 site in 1 country.
United States1 site
NICU at Holtz Children's Hospital
Miami, Florida, 33136
About this study
Official title: Effective Fraction of Inspired Oxygen in Premature Infants Receiving Support Via Nasal Cannula
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).
Read the 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).
- Conditions
- Oxygen Therapy
- Being tested
- Nasal cannula flow rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal cannula flow rateOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal cannula FiO2
FiO2 necessary to maintain the effective FiO2 (measured at the hypopharynx) at the basal level at different nasal cannula flow rates.
Measured: from birth upto 40 weeks corrected postmenstrual age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start4 Apr 2018
- Primary completion1 Jan 2023
- Study completion7 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen TherapyStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nelson Claure, University of Miami
- Investigators
- Nelson Claure, Principal investigator, University of MiamiEduardo Bancalari, Principal investigator, University of MiamiDeepak Jain, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431818
- Sponsor's protocol ID
- 20170816
- Status last verified
- Mar 2025
- First submitted
- 6 Feb 2018
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Fraction of Inspired Oxygen in Premature Infants Receiving Support Via Nasal Cannula
- ClinicalTrials.gov ID
- NCT03431818
- Acronym / sponsor ID
- 20170816
- Conditions
- Oxygen Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 7 Sep 2023 (actual)
- First posted
- 13 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Premature infants admitted to the newborn ICU will be screened. Infants who meet the inclusion criteria will be enrolled in the study after written informed parental consent is obtained:
Key inclusion criteria (3 listed)
- Premature infants born between 23 and 30 weeks of gestational age
- Receiving supplemental oxygen via nasal cannula
- Parental informed consent
Key exclusion criteria (2 listed)
- Major congenital anomalies
- Clinically unstable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal cannula flow rateThis 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. | Other | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: No
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High-Flow Tracheal Oxygen During Spontaneous Breathing Trial
Mechanical Ventilation Weaning, Spontaneous Breathing Trial
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Prognostic Value of Pulpal Blood pH and Oxygen Saturation in Vital Pulp Therapy: Determination of Clinically Relevant Thresholds in a Prospective Clinical Study
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Chronic Obstructive Pulmonary Disease (COPD), Acute Exacerbation of COPD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nelson Claure principal investigator
University of Miami
Eduardo Bancalari principal investigator
University of Miami
Deepak Jain principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oxygen Therapy, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal cannula FiO2 (time frame: from birth upto 40 weeks corrected postmenstrual age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.