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Neonatal unit patient responses to oxygen therapy

Peripheral oxygen saturation responses to changes in the fraction of inspired oxygen in neonatal unit patients on non-invasive respiratory support therapies

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12625000736448
Enrollment
50
Registered
2025-07-11
Start date
2026-07-01
Completion date
2028-06-30
Last updated
2026-06-15

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

Conditions

None listed

Brief summary

Supplemental oxygen therapy is a common therapeutic intervention for neonates as an integral part of respiratory support in the NICU. To our knowledge, there are no detailed public datasets with sufficiently high sampling rates describing the physiological responses of patients to adjustments in oxygen therapy. This study aims to collect data from infants who are prescribed oxygen therapy. The observation period will be up to 24 hours after enrolment. The use of real-world data will help inform the development of future respiratory support devices

Interventions

This observational study is to gather physiological information from infants who are prescribed oxygen therapy during non-invasive respiratory support. Participants will receive the standard care before, during, and after completion of this trial There is no direct patient's involvement. The data will be collected from the patients' observational chart, medical history, and Phillips IntelleVue monitoring system (that continuously tracks a patient’s vital signs and ventilator parameters). The

This observational study is to gather physiological information from infants who are prescribed oxygen therapy during non-invasive respiratory support. Participants will receive the standard care before, during, and after completion of this trial There is no direct patient's involvement. The data will be collected from the patients' observational chart, medical history, and Phillips IntelleVue monitoring system (that continuously tracks a patient’s vital signs and ventilator parameters). The following parameters will be recorded from the observational chart: vital signs, blood gases, ventilation modes and parameters, incubator parameters. The duration of the observation period - is up to 24 hours.

Sponsors

Fisher & Paykel Healthcare LTD
Lead SponsorCommercial sector/Industry

Eligibility

Sex/Gender
All
Age
0 to 3 Months
Healthy volunteers
No

Inclusion criteria

1. Patients who require supplemental oxygen therapy 2. Provision of signed and dated informed consent from the parent/legal guardian 3. Availability for the duration of the study (up to 6 hours of oxygen therapy predicted within a 24-hour observation period)

Exclusion criteria

1. Patients who are intubated 2. Involvement in another investigational study at the same time that may affect the results of this study

Outcome results

None listed

Source: ANZCTR · Data processed: Jun 21, 2026