HypoxiaPhase 2/3FIRST-ABCNCT02612415
FIRST-line Support for Assistance in Breathing in Children (FIRST-ABC) Feasibility Study
A Phase 2/3 study testing Treatment strategy: Non-invasive respiratory support delivered via high flow nasal cannula and Treatment strategy: Non-invasive respiratory support delivered via continuous positive airway pressure in people with Hypoxia and Respiratory Acidosis, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 3 sites in United Kingdom.
Trial summary
A feasibility study to inform the design and conduct of a randomised controlled trial of high flow nasal cannula (HFNC) versus continuous positive airway pressure (CPAP) for non-invasive respiratory support in critically ill children Read more about this study
- Who is it for?
- Ages 36 weeks to 15 years
- Conditions the study is for
- Hypoxia, Respiratory Acidosis, Moderate/Severe Respiratory Distress
- What is being tested?
- Treatment strategy: Non-invasive respiratory support delivered via high flow nasal cannula and Treatment strategy: Non-invasive respiratory support delivered via continuous positive airway pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Nov 2015to Dec 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 weeks to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Eligible patients will fall into one of two groups:
- Group A (Step-up)
- Age >36 weeks corrected gestational age and <16 years, AND
- Deemed to require non-invasive respiratory support by the treating clinician for an acute illness, AND
- Satisfies one or more of the following criteria:
- Hypoxia (oxygen saturation <92% in fraction of inspired oxygen (FiO2) >0.40, or equivalent). FiO2 of 0.40 roughly equates to standard unhumidified nasal cannula oxygen delivered at 6 L/min or oxygen delivered via facemask without a rebreather bag at 6-10 L/min.
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- Acute respiratory acidosis (pH <7.3 with a concomitant pCO2 >6.5 kPa)
- Moderate respiratory distress (use of accessory muscles, subcostal and intercostal recession, tachypnoea for age, grunting)
- Group B (Step-down)
- Age >36 weeks corrected for gestation and <16 years, AND
- Deemed to require non-invasive respiratory support by the treating clinician after extubation, following a spell of invasive ventilation
- Either immediately after extubation as a 'planned' procedure, irrespective of clinical condition ('planned') OR
- Prompted by deterioration in clinical condition within 72 hours after extubation ('rescue'). Clinical parameters to assess the need for NRS in this situation will be similar to point 3 in Group A.
Who cannot join
- Deemed by the treating clinician to require immediate intubation/invasive ventilation due to severe hypoxia, acidosis and/or respiratory distress, upper airway obstruction or recurrent apnoeas
- Tracheostomy in place
- Pre-existing air-leak syndrome (pneumothorax/pneumomediastinum)
- Midfacial/craniofacial anomalies (unrepaired cleft palate, choanal atresia) or had recent craniofacial surgery
- Agreed limitation of intensive care treatment plan in place ('not for intubation')
- On domiciliary non-invasive ventilation prior to PICU admission
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- Managed on either HFNC and/or CPAP (or other form of non-invasive ventilation such as BiPAP) in the preceding 24 hours
- Previously recruited to this study during the same PICU admission
- Cannot be treated with HFNC
- Unavailability of appropriate sized nasal prongs
- Unavailability of HFNC device
- Cannot be treated with CPAP
- Unavailability of right size of face mask, prong or other patient interface
- Unavailability of CPAP device
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Barts Health NHS Trust
London
Great Ormond Street Hospital for Children NHS Foundation Trust
London
Imperial College Healthcare NHS Trust
London
About this study
Official title: FIRST-ABC Feasibility Study: Feasibility Study for a Randomised Trial of High Flow Nasal Cannula (HFNC) Versus Continuous Positive Airway Pressure (CPAP) for Non-invasive Respiratory Support in Critically Ill Children
A feasibility study to inform the design and conduct of a randomised controlled trial of high flow nasal cannula (HFNC) versus continuous positive airway pressure (CPAP) for non-invasive respiratory support in critically ill children
Read the detailed description
Breathing support is the most common intervention provided to critically ill children in a paediatric intensive care unit (PICU). Although invasive breathing support (delivered through a tracheal tube) is lifesaving, concerns regarding its risks (infection and lung damage) have prompted greater use of non-invasive respiratory support (NRS). However, there is little scientific evidence to guide PICU clinicians on the comparative effectiveness of the commonly used modes of NRS.
In this feasibility study, the investigators are testing whether it is possible to conduct a randomised clinical trial comparing two modes of NRS: continuous positive airway pressure (CPAP), which has been used for over two decades, and high flow nasal cannula (HFNC), a newer method of respiratory support. It is not known for sure how useful HFNC is in critically ill children because there is no published research comparing it with CPAP. However, since HFNC is easier to use and better tolerated by children, many hospitals are now using HFNC instead of CPAP. Before HFNC is widely adopted, a clinical trial to establish its role in the management of critically ill children is urgently needed.
As part of this study, the investigators will randomly allocate children deemed to require NRS by their treating clinician to either HFNC or CPAP. The investigators will mainly assess whether sufficient number of children can be recruited to the trial, whether clinicians are willing to randomise children, and test the proposed treatment pathways for CPAP and HFNC. The trial will run over six months, and recruit 120 sick children from three National Health Service (NHS) hospitals. Consent will be sought from parents/guardians for their children to be included in the study, usually before CPAP or HFNC is started, unless emergency life-saving treatment is required, in which case consent will be deferred until there is more time to discuss the study with parents/guardians.
- Being tested
- Treatment strategy: Non-invasive respiratory support delivered via high flow nasal cannula, Treatment strategy: Non-invasive respiratory support delivered via continuous positive airway pressure
- Medical subject headings
- Hypoxia, Acidosis, Respiratory, Lymphoma, Follicular, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment strategy: Non-invasive respiratory support delivered via high flow nasal cannulaDevice
A heated, humidified, HFNC device will be used to deliver a gas flow rate of 2 L/kg/min for the duration that the patient needs non-invasive respiratory support
Treatment strategy: Non-invasive respiratory support delivered via continuous positive airway pressureDevice
CPAP will be provided using a set expiratory pressure of 6-8 cm water (H2O) pressure for the duration that the infant needs non-invasive respiratory support
| Study group | Role | What they receive |
|---|---|---|
| High flow nasal cannula (HFNC) | Experimental | Heated humidified high flow nasal cannula therapy delivered at 2 L/kg/min gas flow rate (for children older than 10 kg in weight, an additional 0.5 L/kg/min per kilogram over 10 kg). Any approved device can be used to deliver HFNC Receives: Device: Treatment strategy: Non-invasive respiratory support delivered via high flow nasal cannula |
| Continuous positive airway pressure (CPAP) | Active comparator | Continuous positive airway pressure delivered using any interface (hood, mask or prongs) Receives: Device: Treatment strategy: Non-invasive respiratory support delivered via continuous positive airway pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of eligible patients in Group A (step-up) and Group B (step-down)
Measured: Baseline
Number of parents/guardians who refuse prospective or deferred consent
Measured: Through study completion, an average of 24 hours
Randomising at least 50% of eligible patients
Measured: Baseline
Proportion of patients adherent to the study treatment
Measured: Through study completion, an average of 72 hours
Mean COMFORT score
Measured: 72 hours
Number of parents completing the Parental Stressor Scale: PICU (PSS:PPICU)
Measured: 24 hours
Secondary outcomes (6)
Proportion of children randomised to the intervention or control who need intubation (Group A) or re-intubation (Group B)
Measured: 72 hours
Proportion of children randomised to the intervention or control who fail the assigned treatment and require either crossover or escalation to other forms of ventilation
Measured: 72 hours
Number of children who experience pre-specified adverse events (pneumothorax, pneumomediastinum, nasal or facial trauma, abdominal distension, nosocomial infection) during the period they are receiving non-invasive respiratory support
Measured: 28 days
Improvement in oxygenation, partial pressure of carbon dioxide (pCO2) levels, heart rate, respiratory rate, and work of breathing
Measured: 24 hours
Length of PICU and hospital stay, length of invasive ventilation, length of non-invasive support, ventilator-free days at day 28
Measured: through study completion, an average of 28 days
Mortality at PICU discharge and at hospital discharge
Measured: through study completion, an average of 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London, Barts & The London NHS Trust, Intensive Care National Audit & Research Centre
- Responsible party
- Sponsor
- Investigators
- Padmanabhan Ramnarayan, Principal investigator, Consultant in Paediatric Intensive Care & Retrieval Children's Acute Transport Service (CATS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612415
- Sponsor's protocol ID
- 14HC30
- Acronym
- FIRST-ABC
- Status last verified
- Dec 2016
- First submitted
- 23 Oct 2015
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Ramnarayan P, Lister P, Dominguez T, Habibi P, Edmonds N, Canter RR, Wulff J, Harrison DA, Mouncey PM, Peters MJ; United Kingdom Paediatric Intensive Care Society Study Group (PICS-SG). FIRST-line support for Assistance in Breathing in Children (FIRST-ABC): a multicentre pilot randomised controlled trial of high-flow nasal cannula therapy versus continuous positive airway pressure in paediatric critical care. Crit Care. 2018 Jun 4;22(1):144. doi: 10.1186/s13054-018-2080-3.
PubMed 29866165Ramnarayan P, Lister P, Dominguez T, Habibi P, Edmonds N, Canter R, Mouncey P, Peters MJ. FIRST-line support for Assistance in Breathing in Children (FIRST-ABC): protocol for a multicentre randomised feasibility trial of non-invasive respiratory support in critically ill children. BMJ Open. 2017 Jun 12;7(6):e016181. doi: 10.1136/bmjopen-2017-016181.
PubMed 28606907
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FIRST-ABC Feasibility Study: Feasibility Study for a Randomised Trial of High Flow Nasal Cannula (HFNC) Versus Continuous Positive Airway Pressure (CPAP) for Non-invasive Respiratory Support in Critically Ill Children
- ClinicalTrials.gov ID
- NCT02612415
- Acronym / sponsor ID
- FIRST-ABC / 14HC30
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Imperial College London, Barts & The London NHS Trust, Intensive Care National Audit & Research Centre
- Study start
- Nov 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 23 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A feasibility study to inform the design and conduct of a randomised controlled trial of high flow nasal cannula (HFNC) versus continuous positive airway pressure (CPAP) for non-invasive respiratory support in critically ill children
Detailed description
Breathing support is the most common intervention provided to critically ill children in a paediatric intensive care unit (PICU). Although invasive breathing support (delivered through a tracheal tube) is lifesaving, concerns regarding its risks (infection and lung damage) have prompted greater use of non-invasive respiratory support (NRS). However, there is little scientific evidence to guide PICU clinicians on the comparative effectiveness of the commonly used modes of NRS.
In this feasibility study, the investigators are testing whether it is possible to conduct a randomised clinical trial comparing two modes of NRS: continuous positive airway pressure (CPAP), which has been used for over two decades, and high flow nasal cannula (HFNC), a newer method of respiratory support. It is not known for sure how useful HFNC is in critically ill children because there is no published research comparing it with CPAP. However, since HFNC is easier to use and better tolerated by children, many hospitals are now using HFNC instead of CPAP. Before HFNC is widely adopted, a clinical trial to establish its role in the management of critically ill children is urgently needed.
As part of this study, the investigators will randomly allocate children deemed to require NRS by their treating clinician to either HFNC or CPAP. The investigators will mainly assess whether sufficient number of children can be recruited to the trial, whether clinicians are willing to randomise children, and test the proposed treatment pathways for CPAP and HFNC. The trial will run over six months, and recruit 120 sick children from three National Health Service (NHS) hospitals. Consent will be sought from parents/guardians for their children to be included in the study, usually before CPAP or HFNC is started, unless emergency life-saving treatment is required, in which case consent will be deferred until there is more time to discuss the study with parents/guardians.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High flow nasal cannula (HFNC) | Experimental | Device: Treatment strategy: Non-invasive respiratory support delivered via high flow nasal cannulaHeated humidified high flow nasal cannula therapy delivered at 2 L/kg/min gas flow rate (for children older than 10 kg in weight, an additional 0.5 L/kg/min per kilogram over 10 kg). Any approved device can be used to deliver HFNC |
| Continuous positive airway pressure (CPAP) | Active comparator | Device: Treatment strategy: Non-invasive respiratory support delivered via continuous positive airway pressureContinuous positive airway pressure delivered using any interface (hood, mask or prongs) |
Who may qualify
- Ages
- 36 weeks to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Group A (Step-up)
- Age >36 weeks corrected gestational age and <16 years, AND
- Deemed to require non-invasive respiratory support by the treating clinician for an acute illness, AND
- Satisfies one or more of the following criteria:
- Group B (Step-down)
Key exclusion criteria (14 listed)
- Deemed by the treating clinician to require immediate intubation/invasive ventilation due to severe hypoxia, acidosis and/or respiratory distress, upper airway obstruction or recurrent apnoeas
- Tracheostomy in place
- Pre-existing air-leak syndrome (pneumothorax/pneumomediastinum)
- Midfacial/craniofacial anomalies (unrepaired cleft palate, choanal atresia) or had recent craniofacial surgery
- Agreed limitation of intensive care treatment plan in place ('not for intubation')
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment strategy: Non-invasive respiratory support delivered via high flow nasal cannulaA heated, humidified, HFNC device will be used to deliver a gas flow rate of 2 L/kg/min for the duration that the patient needs non-invasive respiratory support | Device | High flow nasal cannula (HFNC) |
| Treatment strategy: Non-invasive respiratory support delivered via continuous positive airway pressureCPAP will be provided using a set expiratory pressure of 6-8 cm water (H2O) pressure for the duration that the infant needs non-invasive respiratory support | Device | Continuous positive airway pressure (CPAP) |
Primary outcome
Number of eligible patients in Group A (step-up) and Group B (step-down)
Time frame: Baseline
Number of parents/guardians who refuse prospective or deferred consent
Time frame: Through study completion, an average of 24 hours
Randomising at least 50% of eligible patients
Time frame: Baseline
Proportion of patients adherent to the study treatment
Time frame: Through study completion, an average of 72 hours
Mean COMFORT score
Time frame: 72 hours
Number of parents completing the Parental Stressor Scale: PICU (PSS:PPICU)
Time frame: 24 hours
6 secondary outcomes
Proportion of children randomised to the intervention or control who need intubation (Group A) or re-intubation (Group B)
Time frame: 72 hours
Proportion of children randomised to the intervention or control who fail the assigned treatment and require either crossover or escalation to other forms of ventilation
Time frame: 72 hours
Number of children who experience pre-specified adverse events (pneumothorax, pneumomediastinum, nasal or facial trauma, abdominal distension, nosocomial infection) during the period they are receiving non-invasive respiratory support
Time frame: 28 days
Improvement in oxygenation, partial pressure of carbon dioxide (pCO2) levels, heart rate, respiratory rate, and work of breathing
Time frame: 24 hours
Length of PICU and hospital stay, length of invasive ventilation, length of non-invasive support, ventilator-free days at day 28
Time frame: through study completion, an average of 28 days
Mortality at PICU discharge and at hospital discharge
Time frame: through study completion, an average of 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2016.
- Derived from this study: PubMed 29866165Ramnarayan P, Lister P, Dominguez T, Habibi P, Edmonds N, Canter RR, Wulff J, Harrison DA, Mouncey PM, Peters MJ; United Kingdom Paediatric Intensive Care Society Study Group (PICS-SG). FIRST-line support for Assistance in Breathing in Children (FIRST-ABC): a multicentre pilot randomised controlled trial of high-flow nasal cannula therapy versus continuous positive airway pressure in paediatric critical care. Crit Care. 2018 Jun 4;22(1):144. doi: 10.1186/s13054-018-2080-3.
- Derived from this study: PubMed 28606907Ramnarayan P, Lister P, Dominguez T, Habibi P, Edmonds N, Canter R, Mouncey P, Peters MJ. FIRST-line support for Assistance in Breathing in Children (FIRST-ABC): protocol for a multicentre randomised feasibility trial of non-invasive respiratory support in critically ill children. BMJ Open. 2017 Jun 12;7(6):e016181. doi: 10.1136/bmjopen-2017-016181.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Padmanabhan Ramnarayan principal investigator
Consultant in Paediatric Intensive Care & Retrieval Children's Acute Transport Service (CATS)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Treatment strategy: Non-invasive respiratory support delivered via high flow nasal cannula and Treatment strategy: Non-invasive respiratory support delivered via continuous positive airway pressure in people with Hypoxia and Respiratory Acidosis, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of eligible patients in Group A (step-up) and Group B (step-down) (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02612415, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2016.