Safety and efficacy of automated targeting of oxygen therapy in premature infants

Not Applicable

Active, not recruiting

• Conditions: Premature birth; Respiratory insufficiency of prematurity; Respiratory - Other respiratory disorders / diseases; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12616000300471
• Lead Sponsor: Menzies Institute for Medical Research, University of Tasmania

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

i) Preterm birth at <32 weeks gestation
ii) Requirement for non-invasive respiratory support, including continuous positive airway pressure (CPAP), or high flow via nasal cannula (HF).
iii ) Either a) requirement for supplemental oxygen at the time of commencing the study, or b) in room air but showing a propensity to hypoxic events with or without apnoea.
iv) Research team available to commence recording.

Exclusion Criteria

Currently ventilated or in imminent need of intubation and ventilation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Eupoxia - proportion of time with oxygen saturation (SpO2) in the desired target range, or above the desired target range when no supplemental oxygen is being administered. This is assessed by analysis of data received from the pulse oximeter at a sampling frequency of 1 Hz. [Continuous monitoring second by second throughout the 24 hour study period]