Cerebral Perfusion and Acute Respiratory Failure

November 8, 2018 updated by: Liverpool John Moores University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L14 5AB
        • Recruiting
        • Alder Hey Children's NHS Foundation Trust
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

An estimation of 20, infants and children admitted with acute respiratory failure will be recruited from Alder Hey.

Description

Inclusion Criteria:

  • All neonates, infants and children undergoing treatment for acute respiratory failure.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Control
'Healthy babies' to establish 'normal' blood flow in neonates.
Other: TCD
Transcranial Doppler will be used to measure brain blood flow in the middle cerebral artery.
ECMO
Children undergoing extracorporeal membrane oxygenation for acute respiratory failure.
Other: TCD
Transcranial Doppler will be used to measure brain blood flow in the middle cerebral artery.
Conventional
Neonates undergoing conventional treatment for acute respiratory failure.
Other: TCD
Transcranial Doppler will be used to measure brain blood flow in the middle cerebral artery.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
5 minutes for each scan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Liverpool John Moores University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Alder Hey Children's NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 240082

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

All information taken will be anonymised.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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