NCT03431818

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 13, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

April 4, 2018

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2023

Completed
Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

4.7 years

First QC Date

February 6, 2018

Last Update Submit

March 17, 2025

Conditions

Oxygen Therapy

Outcome Measures

Primary Outcomes (1)

  • Nasal cannula FiO2

    FiO2 necessary to maintain the effective FiO2 (measured at the hypopharynx) at the basal level at different nasal cannula flow rates.

    from birth upto 40 weeks corrected postmenstrual age

Interventions

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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:

You may qualify if:

  • Premature infants born between 23 and 30 weeks of gestational age
  • Receiving supplemental oxygen via nasal cannula
  • Parental informed consent

You may not qualify if:

  • Major congenital anomalies
  • Clinically unstable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NICU at Holtz Children's Hospital

Miami, Florida, 33136, United States

Location

Study Officials

  • Nelson Claure

    University of Miami

    PRINCIPAL INVESTIGATOR

  • Eduardo Bancalari

    University of Miami

    PRINCIPAL INVESTIGATOR

  • Deepak Jain

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 6, 2018

First Posted

February 13, 2018

Study Start

April 4, 2018

Primary Completion

January 1, 2023

Study Completion

September 7, 2023

Last Updated

March 20, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)