Condition category
Respiratory
Date applied
19/10/2012
Date assigned
14/11/2012
Last edited
07/07/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Mild breathing difficulties are common in children with weakened immunity. However, if a child develops severe breathing difficulties, this can result in damage to the lungs to the point where they no longer function properly and the child requires support from a special machine called a mechanical ventilator, which breathes for them. Currently, if a child develops severe breathing difficulties, they are treated on the ward with oxygen, antibiotics and careful control of fluids. If, despite this treatment, their breathing difficulties get worse, they will usually be admitted to the intensive care unit for further treatment. This often involves the child receiving a general anaesthetic to allow them to be attached to a mechanical ventilator to help them breathe. Recent studies in adults with impaired immunity have shown that it might be better to admit patients to the intensive care unit earlier, before their breathing problems get worse, for a treatment called continuous positive airway pressure (CPAP). CPAP is a technique for keeping lungs well inflated by the use of gentle air pressure via a face mask. In theory, holding the lungs open a little more with the extra pressure of CPAP should make the effort of breathing less, and reduce the risk of further chest infections. Patients in the studies who received CPAP early were less likely to need a general anaesthetic and mechanical ventilation. However, these studies only involved small numbers of patients who were all adults. More research is needed which also includes children. We do not know if early treatment with CPAP is better, so the purpose of this study is to find out if early admission to the intensive care unit for CPAP results in more children recovering from severe breathing difficulties compared to usual treatment.

Who can participate?
Children aged less than 18 years who are being treated at participating hospitals, with weakened immunity and severe breathing difficulties.

What does the study involve?
If a child is assigned to the CPAP group, he/she will be admitted to the intensive care unit and have CPAP delivered via a face mask for a minimum of 12 hours per day for at least four consecutive days. After this, the child will receive usual treatment as directed by the medical team which may or may not include continuing with CPAP. The child will be monitored closely by the medical team. If a child is assigned to the usual treatment group, he/she will continue to receive treatment on the ward, including oxygen therapy, antibiotics and fluids. The child will be monitored closely by the medical team. If the child requires more intensive treatment, he/she will be admitted to the intensive care unit in accordance with standard acutely ill child protocols and as deemed necessary by the ICU outreach/medical rapid response teams and the clinical team responsible for the child’s care.

What are the possible benefits and risks of participating?
Participants will be playing an important part in finding out what is the best way to help young people like them to get better. We can’t promise this research will help children, but they will be helping others just like them who have the same problems in the future. All medical procedures, regardless of study participation, involve some risk of injury. We are doing this study because we do not know if early admission to the intensive care unit for CPAP is better than continuing treatment on the ward. Delivery of CPAP requires the child to wear a moderately tight-fitting face mask and it is possible that they may not feel comfortable with the face mask on. However, most children with severe breathing difficulties recognise very quickly that once the face mask is in position that breathing is much easier. If a child does find the face mask difficult to tolerate, the medical team will make a decision about whether to try gentle sedation to assist with the CPAP or to leave the face mask off. If the face mask is used for many days there is a risk of areas of skin becoming sore where the face mask is in contact with the skin, particularly on the bridge of the nose. This risk can usually be minimised by giving rest periods off the CPAP mask or by changing the mask shape from time to time.

Where is the study run from?
The study will take place at four NHS hospitals in the UK and is being managed by the Intensive Care National Audit & Research Centre (ICNARC).

When is the study starting and how long is it expected to run for?
The study will run from January 2013 to January 2016.

Who is funding the study?
The study is being funded by the Great Ormond Street Hospital Children’s Charity, Registered Charity No 235825.

Who is the main contact?
Dr Mark Peters
mark.peters@ucl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mark Peters

ORCID ID

Contact details

Reader in Paediatric Intensive Care and Hon Consultant Intensivist
Critical Care Group – Portex Unit
Institute of Child Health (UCL)
30 Guilford Street
London
WC1N 1EH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10AR31

Study information

Scientific title

Randomised Study of early Continuous positive airway pressure in Acute Respiratory Failure in children with impaired immunity

Acronym

SCARF

Study hypothesis

Early admission to the paediatric intensive care unit (PICU) for delivery of continuous positive airway pressure (CPAP) will reduce the need for intubation and invasive mechanical ventilation within 30 days and improve survival from both acute and acute on chronic respiratory failure in children with impaired immunity.

On 07/07/2014 the following changes were made to the trial record:
1. The study design was changed from 'Single centre pragmatic open randomised controlled trial' to 'Multi-centre pragmatic open randomised controlled trial'
2. The anticipated start date was changed from 09/11/2012 to 01/01/2013
3. The anticipated end date was changed from 08/11/2016 to 01/01/2017

Ethics approval

NRES Committee London - Riverside, 13/08/2012, ref: 12/LO/1051

Study design

Multi-centre pragmatic open randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Acute respiratory failure in immune impaired children

Intervention

Current interventions as of 07/07/2014:
Intervention group
Participants allocated to the intervention group will be admitted to the PICU and receive Continuous Positive Airway Pressure (CPAP) of at least 6 cm of water (PEEP) with supplemental oxygen for a minimum of 12 hours per day for at least four consecutive days. The interface for delivering CPAP (i.e. via face mask, helmet or infant flow-driver) will be at the discretion of the clinical team responsible for the patient’s care. All other care will be determined by the clinical team primarily responsible for the patient’s care.

Control group
Participants allocated to the control group will remain on the ward and receive supplemental oxygen to maintain oxygen saturation in accordance with standard local practice. All other care (including antimicrobial therapy, fluid therapy, analgesia and sedative agents, bronchodilator therapy) will be determined by the clinical team primarily responsible for the child’s care. Participants in the control group will be admitted to the PICU in accordance with standard acutely ill child protocols and as deemed necessary by the ICU outreach/medical rapid response teams and the clinical team responsible for the child’s care.

Previous interventions:
Intervention group
Participants allocated to the intervention group will be admitted to the PICU and receive Continuous Positive Airway Pressure (CPAP) of at least 6 cm H2O with supplemental oxygen for a minimum of 12 hours per day for at least four consecutive days. The interface for delivering CPAP (i.e. via face mask, helmet or infant flow-driver) will be at the discretion of the clinical team responsible for the patient’s care. All other care will be determined by the clinical team primarily responsible for the patient’s care.

Control group
Participants allocated to the control group will remain on the ward and receive supplemental oxygen to maintain oxygen saturation in accordance with standard local practice (Level 1 respiratory support – see: Section 10.3). All other care (including antimicrobial therapy, fluid therapy, analgesia and sedative agents, bronchodilator therapy) will be determined by the clinical team primarily responsible for the child’s care. Participants in the control group will be admitted to the PICU in accordance with standard Great Ormond Street Hospital acutely ill child protocols and as deemed necessary by the Intensive Care Outreach Network/Clinical Site Practitioner and the clinical team responsible for the child’s care.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Requirement for intubation and invasive mechanical ventilation within 30 days post-randomisation

Secondary outcome measures

1. Maximum and aggregate daily organ failure score
2. Mortality at 30 days post-randomisation
3. Requirement for Level 2 or Level 3 respiratory support within 30 days post-randomisation
4. Days free from any ventilator support at 30 days post-randomisation
5. Days free from supplemental oxygen (i.e., above pre-acute respiratory failure requirement) at 30 days post-randomisation
6. Hospital mortality
7. Mortality at 90 days post-randomisation
8. Mortality 1 year post-randomisation

Overall trial start date

01/01/2013

Overall trial end date

01/01/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 07/07/2014:
1. Age less than 18 years
2. Expected to have impaired immunity for at least 3 months as a result of a primary diagnosis, therapy or a combination of both
3. Acute respiratory failure or acute on chronic respiratory failure

Previous inclusion criteria:
1. Age less than 16 years
2. Expected to have impaired immunity for at least 3 months as a result of a primary diagnosis, therapy or a combination of both
3. Acute respiratory failure or acute on chronic respiratory failure

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

148

Participant exclusion criteria

1. Already receiving invasive mechanical ventilation for non-respiratory indications
2. Other acute indication for emergency PICU admission and invasive mechanical ventilation, independent of the degree of respiratory failure (e.g., shock, reduced level of consciousness, seizures), as assessed by the PICU team
3. Recent oesophageal/gastric surgery
4. End-of-life care plan in place with limitation of resuscitation
5. Life expectancy less than 12 months
6. Already receiving treatment on PICU

Recruitment start date

01/01/2013

Recruitment end date

01/01/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Reader in Paediatric Intensive Care and Hon Consultant Intensivist
London
WC1N 1EH
United Kingdom

Sponsor information

Organisation

Great Ormond Street Hospital for Children NHS Foundation Trust (UK)

Sponsor details

Joint Research and Development Office
Division of Research and Innovation
NHS Foundation Trust & The UCL Institute of Child Health
2nd Floor
30 Guilford Street
London
WC1N 1EH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.gosh.org/

Funders

Funder type

Charity

Funder name

Great Ormond Street Hospital for Children’s Charity (UK), ref: 235825

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes