Cerebral Perfusion and Acute Respiratory Failure

NCT03733795 | Unknown

• 1 other identifier: 240082
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Blood Flow and Neonates During Acute Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Differences in cerebral blood flow

  Transcranial Doppler will be used to measure blood flow in the middle cerebral artery.

  5 minutes for each scan

Study Arms (3)

Control

'Healthy babies' to establish 'normal' blood flow in neonates.

Other: TCD

ECMO

Children undergoing extracorporeal membrane oxygenation for acute respiratory failure.

Other: TCD

Conventional

Neonates undergoing conventional treatment for acute respiratory failure.

Other: TCD

Interventions

TCD OTHER

Transcranial Doppler will be used to measure brain blood flow in the middle cerebral artery.

Control; Conventional; ECMO

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liverpool John Moores University: lead
• Alder Hey Children's NHS Foundation Trust: collaborator

Study Sites (1)

Alder Hey Children's NHS Foundation Trust

Liverpool, Merseyside, L14 5AB, United Kingdom

RECRUITING

Central Study Contacts

Lucy Finnigan, MRes and BSc (Hons)- 1:1

CONTACT

07585775332; L.E.Finnigan@2017.ljmu.ac.uk

Helen Jones, PhD

CONTACT

01519046270; H.Jones1@ljmu.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 7, 2018
• Study Start: November 1, 2018
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: November 9, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)