Controlled oxygen administration in term newborns and young infants requiring mechanical respiratory support and oxygen therapy

Not Applicable

Recruiting

• Conditions: eonatal hypoxic respiratory failure; Respiratory tract infection of infancy; Neonatal hypoxic respiratory failure; Respiratory - Other respiratory disorders / diseases; Infection - Other infectious diseases

• Registration Number: ACTRN12619000742178
• Lead Sponsor: Murdoch Childrens Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-17
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Term newborns with hypoxic respiratory failure, and young infants with respiratory insufficiency related to respiratory tract infection, fulfilling the eligibility criteria outlined below.
Participants will be assigned to a randomised trial treatment only if they meet all of the inclusion criteria and none of the exclusion criteria.

Inclusion criteria
Each participant must meet all of the following criteria in either study population (‘Study group A’ or Study group B’) to be enrolled in the study.

Study group A: Term and near-term infants requiring mechanical respiratory support and oxygen therapy of any duration due to hypoxic respiratory failure (HRF).
•Gestation at birth greater than or equal to 35 completed weeks.
•Chronological age less than or equal to 2 months.
•HRF related to any of parenchymal lung disease, neonatal acute respiratory distress syndrome, pulmonary hypertension or diaphragmatic hernia
•Receiving non-invasive respiratory support (CPAP and HFNC), or intubated and mechanically ventilated using any of the modes available with the SLE6000 ventilator.

Study group B: Young infants requiring non-invasive or invasive mechanical respiratory support and supplemental oxygen therapy of any duration secondary to RTI.
•Any gestation at birth.
•Chronological age less than or equal to 9 months and corrected gestational age less than or equal to 6 months
•Respiratory insufficiency due to respiratory tract infection (viral or bacterial)
•Receiving non-invasive respiratory support (CPAP and HFNC), or intubated and mechanically ventilated using any of the modes available with the SLE6000 ventilator.

For participants in both groups, the following inclusion criteria must be met:
•Supplemental oxygen therapy being administered at study entry (baseline oxygen requirement at least 30%).
•SLE6000 ventilator with OxyGenie® option available for the study.
•Research team available to commence recording.
•Agreement of treating clinicians that the participant is appropriate for study.

Exclusion Criteria

Exclusion criteria (common to both study groups):
•Cardiorespiratory instability that precludes entry into a study.
•Change in mode of respiratory support anticipated in next 24 hours.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of time within the SpO2 target range (SpO2 92-96%, inclusive). This proportion will be determined for the entire period of manual control, and automated control, for each subject.<br><br>This outcome will be assessed using pulse oximetry measures recorded and logged by the SLE6000 ventilator,[At completion of the 2 x 12 hour crossover study]

Secondary Outcome Measures

Name	Time	Method
Proportion of time spent within hypoxic SpO2 ranges. This proportion will be determined for the entire period of automated control and manual control for each participant.<br>Hypoxic SpO2 ranges are:<br>•SpO2 <80%<br>•SpO2 80-84%<br>•SpO2 85-89%<br><br>The time in in hypoxia will be determined using the 1 Hz data log extracted from the SLE6000 ventilator. [At the end of the 2 x12 hour crossover study];Proportion of time spent within hyperoxic SpO2 ranges. This proportion will be determined for the entire period of automated control and manual control for each participant.<br><br>Hyperoxic SpO2 ranges are:<br>•SpO2 >96% when receiving supplemental oxygen<br>•SpO2 >98% when receiving supplemental oxygen<br><br>The time in in hyperoxia will be determined using the 1 Hz data log extracted from the SLE6000 ventilator. [At the end of the 2 x12 hour crossover study]