Cerebral Blood Flow and Neonates During Acute Respiratory FailureNCT03733795
Cerebral Perfusion and Acute Respiratory Failure
An observational study of Cerebral Blood Flow and Neonates During Acute Respiratory Failure, run by Liverpool John Moores University at 1 site in United Kingdom.
Trial summary
The most common reason for admitting babies and infants to an intensive care unit is due to respiratory distress (breathing difficulties). At present there are a number of different treatments for respiratory distress. Read more about this study
- Who is it for?
- Ages Up to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Blood Flow and Neonates During Acute Respiratory Failure
- What is being tested?
- TCD
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2018to Oct 2020
- Phase
- Observational
- 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 Up to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: An estimation of 20, infants and children admitted with acute respiratory failure will be recruited from Alder Hey.
Who may be able to join
- All neonates, infants and children undergoing treatment for acute respiratory failure.
Who cannot join
- Parents/guardians who do not wish for their child to participate.Parents/ guardians who are unable to provide written consent.
- Patients who clinicians feel are inappropriate to approach.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Alder Hey Children's NHS Foundation Trust
Liverpool, Merseyside, L14 5AB
Lucy Finnigan, MRes, BSc (Hons), 07585775332, L.E.Finnigan@2017.ljmu.ac.uk
Helen Jones, PhD, 01519046270, H.Jones1@ljmu.ac.uk
About this study
Official title: Cerebral Perfusion During Intervention for Acute Respiratory Failure
The most common reason for admitting babies and infants to an intensive care unit is due to respiratory distress (breathing difficulties). At present there are a number of different treatments for respiratory distress. These include drug treatments; non-invasive ventilation, where oxygen is given at high pressure to push it through the baby's lungs: ventilation where the baby is put on a breathing machine; or Extracorporeal Membrane Oxygenation (ECMO). This works by taking the blood from the body via a tube (usually) in the baby's neck, redirecting through a machine that oxygenates the blood, then returning it to the baby through another tube. Currently we know little about how different treatments have a different impact on brain perfusion (how much oxygen the brain gets). Using specialist, noninvasive ultrasound and doppler techniques, we are proposing to monitor the effect of these treatments on the brain.
Read the detailed description
Following admission to Paediatric Intensive Care Unit, the clinical team will approach the parents of patients admitted with respiratory failure and introduce the research project. It is unlikely that parents will be have the capacity to provide meaningful full consent at this stage, as admission will be as an emergency. Therefore a two staged approach is proposed. Clinicians will act as gatekeepers to the parents. Parents/ patients deemed suitable for recruitment by clinicians will be provided with a brief explanation of the scan, and introduced to the researcher. Parents/patients may be deemed unsuitable should there be communication issues, legal issues (such as children in care) or clinical issues (where clinicians feel the patient is unlikely to survive and the research would be intrusive). With the parent's permission (documented in the research paperwork), scan data will collected from the patient. However, this will not be analysed or downloaded until after the second stage of consent. At a time deemed appropriate by the clinicians (based on clinical experience, this is expected to be within 24 hours of arrival) the researcher will provide a full explanation of the research and formally record parental consent on an approved form. At this point data generated will be downloaded and analysed. Should the parents refuse no more data will be collected. The measurements of brain blood flow will be taken using small probes located either side of the head. These will be held in place by either tape or a tubular bandage. Using an ultrasound images of the blood vessels (and flow) in the brain will also be measured at the same time. These measurements will be taken for 5-10 minutes on each occasion. Depending on treatment pathway, the data will be collected as follows: Measurements will be taken before treatment starts (in ECMO only). When the child is going onto treatment (during cannulation (ECMO) or intubation conventional)).
One hour after treatment has begun (ECMO only) 24 hours after treatment has started and then on a daily basis for the duration of treatment. During the weaning period where the patient is being prepared to come off treatment.
When the patient is being took off treatment (de-cannulation/extubation). One hour after they have been took off treatment. 24 hours after treatment has stopped. Not all the time points at which data will be collected will be applicable in every case.
Parents can withdraw consent at any point until data is analysed. No identifiable data will be recorded, apart from the consent forms.
- Being tested
- TCD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCDOther
Transcranial Doppler will be used to measure brain blood flow in the middle cerebral artery.
| Study group | Role | What they receive |
|---|---|---|
| Control | 'Healthy babies' to establish 'normal' blood flow in neonates. Receives: Other: TCD | |
| ECMO | Children undergoing extracorporeal membrane oxygenation for acute respiratory failure. Receives: Other: TCD | |
| Conventional | Neonates undergoing conventional treatment for acute respiratory failure. Receives: Other: TCD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in cerebral blood flow
Transcranial Doppler will be used to measure blood flow in the middle cerebral artery.
Measured: 5 minutes for each scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study startNov 2018 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Blood Flow and Neonates During Acute Respiratory FailureStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Collaborators
- Alder Hey Children's NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733795
- Sponsor's protocol ID
- 240082
- Status last verified
- Oct 2018
- First submitted
- 6 Nov 2018
- Last updated
- 9 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All information taken will be anonymised.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Perfusion During Intervention for Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT03733795
- Acronym / sponsor ID
- 240082
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Collaborators
- Alder Hey Children's NHS Foundation Trust
- Study start
- Nov 2018 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 7 Nov 2018 (actual)
- 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.
The most common reason for admitting babies and infants to an intensive care unit is due to respiratory distress (breathing difficulties). At present there are a number of different treatments for respiratory distress. These include drug treatments; non-invasive ventilation, where oxygen is given at high pressure to push it through the baby's lungs: ventilation where the baby is put on a breathing machine; or Extracorporeal Membrane Oxygenation (ECMO). This works by taking the blood from the body via a tube (usually) in the baby's neck, redirecting through a machine that oxygenates the blood, then returning it to the baby through another tube. Currently we know little about how different treatments have a different impact on brain perfusion (how much oxygen the brain gets). Using specialist, noninvasive ultrasound and doppler techniques, we are proposing to monitor the effect of these treatments on the brain.
Detailed description
Following admission to Paediatric Intensive Care Unit, the clinical team will approach the parents of patients admitted with respiratory failure and introduce the research project. It is unlikely that parents will be have the capacity to provide meaningful full consent at this stage, as admission will be as an emergency. Therefore a two staged approach is proposed. Clinicians will act as gatekeepers to the parents. Parents/ patients deemed suitable for recruitment by clinicians will be provided with a brief explanation of the scan, and introduced to the researcher. Parents/patients may be deemed unsuitable should there be communication issues, legal issues (such as children in care) or clinical issues (where clinicians feel the patient is unlikely to survive and the research would be intrusive). With the parent's permission (documented in the research paperwork), scan data will collected from the patient. However, this will not be analysed or downloaded until after the second stage of consent. At a time deemed appropriate by the clinicians (based on clinical experience, this is expected to be within 24 hours of arrival) the researcher will provide a full explanation of the research and formally record parental consent on an approved form. At this point data generated will be downloaded and analysed. Should the parents refuse no more data will be collected. The measurements of brain blood flow will be taken using small probes located either side of the head. These will be held in place by either tape or a tubular bandage. Using an ultrasound images of the blood vessels (and flow) in the brain will also be measured at the same time. These measurements will be taken for 5-10 minutes on each occasion. Depending on treatment pathway, the data will be collected as follows: Measurements will be taken before treatment starts (in ECMO only). When the child is going onto treatment (during cannulation (ECMO) or intubation conventional)).
One hour after treatment has begun (ECMO only) 24 hours after treatment has started and then on a daily basis for the duration of treatment. During the weaning period where the patient is being prepared to come off treatment.
When the patient is being took off treatment (de-cannulation/extubation). One hour after they have been took off treatment. 24 hours after treatment has stopped. Not all the time points at which data will be collected will be applicable in every case.
Parents can withdraw consent at any point until data is analysed. No identifiable data will be recorded, apart from the consent forms.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: TCD'Healthy babies' to establish 'normal' blood flow in neonates. |
| ECMO | – | Other: TCDChildren undergoing extracorporeal membrane oxygenation for acute respiratory failure. |
| Conventional | – | Other: TCDNeonates undergoing conventional treatment for acute respiratory failure. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- An estimation of 20, infants and children admitted with acute respiratory failure will be recruited from Alder Hey.
Key inclusion criteria (1 listed)
- All neonates, infants and children undergoing treatment for acute respiratory failure.
Key exclusion criteria (2 listed)
- Parents/guardians who do not wish for their child to participate.Parents/ guardians who are unable to provide written consent.
- Patients who clinicians feel are inappropriate to approach.
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 |
|---|---|---|
| TCDTranscranial Doppler will be used to measure brain blood flow in the middle cerebral artery. | Other | Control, Conventional, ECMO |
Primary outcome
Differences in cerebral blood flow
Time frame: 5 minutes for each scan
Transcranial Doppler will be used to measure blood flow in the middle cerebral artery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2018.
- Individual participant dataSharing planned: No. All information taken will be anonymised.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Blood Flow and Neonates During Acute Respiratory Failure, run by Liverpool John Moores University at 1 site 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 9 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucy Finnigan, MRes and BSc (Hons)- 1:1 (07585775332, L.E.Finnigan@2017.ljmu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in cerebral blood flow (time frame: 5 minutes for each scan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2018.