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Cerebral Perfusion and Acute Respiratory Failure

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ClinicalTrials.gov Identifier: NCT03733795
Recruitment Status : Recruiting
First Posted : November 7, 2018
Last Update Posted : November 9, 2018
Sponsor:
Collaborator:
Alder Hey Children's NHS Foundation Trust
Information provided by (Responsible Party):
Liverpool John Moores University

Brief 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. 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.

Condition or disease Intervention/treatment
Cerebral Blood Flow and Neonates During Acute Respiratory Failure Other: TCD

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.


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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Cerebral Perfusion During Intervention for Acute Respiratory Failure
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03733795


Contacts
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Contact: Lucy Finnigan, MRes and BSc (Hons)- 1:1 07585775332 L.E.Finnigan@2017.ljmu.ac.uk
Contact: Helen Jones, PhD 01519046270 H.Jones1@ljmu.ac.uk

Locations
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United Kingdom
Alder Hey Children's NHS Foundation Trust Recruiting
Liverpool, Merseyside, United Kingdom, L14 5AB
Contact: Lucy Finnigan, MRes, BSc (Hons)    07585775332    L.E.Finnigan@2017.ljmu.ac.uk   
Contact: Helen Jones, PhD    01519046270    H.Jones1@ljmu.ac.uk   
Sponsors and Collaborators
Liverpool John Moores University
Alder Hey Children's NHS Foundation Trust

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Responsible Party: Liverpool John Moores University
ClinicalTrials.gov Identifier: NCT03733795     History of Changes
Other Study ID Numbers: 240082
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All information taken will be anonymised.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases