Evaluation of automated control of oxygen therapy in extremely preterm infants: the SCION trial

Not Applicable

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

• Registration Number: ACTRN12616000301460
• 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: ot yet recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Gestation at birth 23 weeks 0 days to 27 weeks 6 days by best obstetric estimate.
Age <24 hours, and managed in room air or supplemental oxygen.
Signed parental consent.

Exclusion Criteria

Withdrawal of active treatment being considered.
Congenital anomaly likely to adversely affect outcome.
Lack of availability of automated control device or study personnel.

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.[Throughout the period from birth to 36 weeks post-menstrual age.]