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Baby SPICE Pilot Study

ANZICS CTG Endorsed Study

Baby SPICE Pilot Study

Sedation practice in paediatric intensive care in Australia and New Zealand

Study Description

Intravenous sedatives and analgesics are commonly administered to mechanically ventilated children, however there is substantial variability in sedation practices in different intensive care units and in different countries around the world. The BabySPICE pilot study will evaluate the hypothesis that a sedation regimen based on safe, light sedation with dexmedetomidine as the primary sedative agent and in which benzodiazepine use is minimised, will lead to improved patient centred outcomes. The purpose of the BabySPICE Pilot RCT is to obtain preliminary data on the feasibility and safety of conducting a study that tests this hypothesis.

This is a pilot prospective randomised controlled trial that will be conducted in six tertiary paediatric intensive care units in Australia and New Zealand and will recruit 60 patients with a maximum of 15 patients from each participating site. The study will recruit patients ventilated for less than 12 hours, who are expected to remain ventilated at least 24 hours after enrolment AND need immediate and ongoing sedation. Patients will be recruited into one of two study groups. The intervention arm will receive dexmedetomidine as the primary agent, with the addition of second line sedatives as required. The use of benzodiazepines in this arm will be minimized and clonidine will not be used concurrently with dexmedetomidine. The control arm will have sedation according to usual practice as chosen by the treating clinician. This may include the use of clonidine according to standard unit practice but can only include dexmedetomodine as a last resort if all other agents have failed. In both groups, the default sedation level is light sedation, as defined by a target State Behaviour Scale (SBS) of -1 to +1, unless otherwise specified by the treating clinician. The primary outcome measure for the pilot study is to demonstrate separation between the intervention group (GpDex) and a ‘wildtype’ (usual practice) control group (GpStd) with respect to the proportion of patients achieving light sedation (SBS -1 to +1) in the first 48 hours of sedation in intensive care. Information from the Pilot RCT will be used to design a subsequent phase III trial.

Management Committee

Simon Erickson (Chair / Project Manager), Brian Anderson, John Awad, John Beca, Carmel Delzoppo, Marino Festa, Debbie Long, Mary Lou Morritt, Johnny Millar, Yahya Shehabi, Claire Sherring and Tony Slater.

Administering Institution

Perth Children’s Hospital, Perth

Collaborators

​Hospira Ltd (Melbourne, Australia)

Sample Size

60 patients

Funding

Hospira Ltd (Melbourne, Australia) Unrestricted Grant $15,000
Princess Margaret Hospital for Children Research Foundation $20,000

Project Status as of June 2018

The project has been completed including follow up. Preliminary data analysis has been performed and a manuscript is currently in preparation.

An abstract has been accepted for presentation at the Pediatric Critical Care World Congress in Singapore, June 2018

The abstract has also been submitted for the ANZICS ASM 2018.

Reference

CTG 1314-09
ACTRN12614000225617

Contact

​Simon Erickson (email)
Debbie Long (email)