European Paediatric AFM Associated With EV-D68 Follow-up Study.

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ClinicalTrials.gov Identifier: NCT03499366

Recruitment Status : Unknown

Verified May 2018 by Helle Cecilie Viekilde Pfeiffer, Oslo University Hospital.
Recruitment status was: Recruiting

First Posted : April 17, 2018

Last Update Posted : May 11, 2018

Sponsor:

Collaborators:

University Medical Center Groningen

National Health Service, United Kingdom

Information provided by (Responsible Party):

Helle Cecilie Viekilde Pfeiffer, Oslo University Hospital

Study Description

Brief Summary:

The study is a follow-up study on children with acute flaccid paresis associated with enterovirus D68 infection. Only children living in Europe are eligible. The study aim is to clarify the outcome of the disease and investigate possible clinical correlation with outcome, including initial severity, demographic characteristics, treatment and MRI findings.

Condition or disease	Intervention/treatment	Phase
Flaccid Hemiplegia Flaccid Paraplegia Flaccid Tetraplegia, Unspecified Enterovirus D68 Myelitis, Infectious	Diagnostic Test: HFMS, MRC, ACTIVLIM, PedsQl-4.0	Not Applicable

Show detailed description

Detailed Description:

Title: Clinical observational follow-up study of children with Acute Flaccid Myelitis associated with EV-D68 infection- a cross European collaboration.

Study objectives: To study the clinical outcome and function of patients with Acute Flaccid Myelitis associated with enterovirus (EV)-D68 infection after 1 to 3 years, in order to assist clinicians in providing prognoses for patients and to guide further investigation.

Primary objective will be:

• Functional assessment using the Hammersmith Functional Motor Scale (HFMS) -score at follow up; 1, 2 and three years depending on time of debut

Secondary objectives are to describe these secondary outcomes and their changes over time, from onset to 1, 2 and 3 years, depending on time of debut:

Medical Research Council (MRC) sum score at acute illness and at 1, 2 and 3 years follow up depending on time of debut as well as possible improvements over time
MRC score in the most affected joint at acute illness and at 1, 2 and 3 years follow up depending on time of debut, as well as possible improvements over time ACTIVLIM functional score at 1, 2 and 3 years follow up depending on time of debut
Quality of life at 1, 2 and 3 years follow up depending on time of onset measured using the Paediatric Quality of Life Inventory (PedsQL) 4.0.
Number of days needing intensive care (range and mean)
Number of days needing mechanical ventilation (range and mean)
Number of deaths will be reported
Number of complete recoveries will be reported

Explorative objectives:

Exploring demographic parameters and how it relates to outcome (HFMS/ MRC-score/ ACTIVLIM/ PedsQL 4.0)
Exploring different treatments and how it relates to outcome (HFMS/ MRC-score/ ACTIVLIM/ PedsQL 4.0)
Exploring different clinical parameters and how it relates to outcome (HFMS/ MRC-score/ ACTIVLIM/ PedsQL 4.0)
Exploring time aspects of the recovery process (individual MRC-score and MRC sum score changes).
Characteristics on MRI will be explored with regards to outcome measures (HFMS/ MRC-score/ ACTIVLIM/ PedsQL 4.0)
In cases with repeated MRI scans, changes will be described
In cases with repeated neurophysiological examinations, changes will be described.

Clinical study/intervention design: This is a clinical observational study aiming at including all registered European AFM-EVD68 patients less than 18 years of age.

Safety endpoints: There is no treatment given in this study. If we become aware of important safety issues concerning included patient's treatment regimens or supportive treatment the responsible treating physician well be informed promptly via e-mail.

Duration of study: The study is intended to produce follow up data every year for two years. Inclusion will begin in March 2018 and the study terminates in March 2020. Analysis of data might hereafter continue for one year.

Follow-up: The study is a follow up study itself. Follow up will be done as close to 1 year after onset as possible and hereafter every year for minimal 2 years.

The study is intended as a clinical follow-up study exploring the outcome of patients with acute flaccid paresis associated with enterovirus D68. The patients will undergo a standard neurologic examination and assessment using Hammersmith functional motor scale expanded. The parents/ child will be asked to fill out a form concerning quality of life and activity of daily living. There will be no painful or invasive procedures and the duration of each visit can be expected to be approx. 4 hours.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	40 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	A Clinical Observational Follow-up Study of European Pediatric Cases of Acute Flaccid Myelitis Associated With EV-D68 Infection.
Actual Study Start Date :	April 9, 2018
Estimated Primary Completion Date :	April 9, 2020
Estimated Study Completion Date :	May 1, 2020

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Paraplegia Myelitis Acute Flaccid Myelitis

U.S. FDA Resources

Arms and Interventions

Intervention Details:

Diagnostic Test: HFMS, MRC, ACTIVLIM, PedsQl-4.0
Clinical performance tests, quality of life, activity of daily life form.

Outcome Measures

Primary Outcome Measures :

Total Hammersmith Functional Motor scale- score at follow-up [ Time Frame: 1 year ]
O'Hagen, J. M., et al. (2007). "An expanded version of the Hammersmith Functional Motor Scale for SMA II and III patients." Neuromuscul Disord 17(9-10): 693-697.Neurol. 2003;7(4):155-9.

The scale is a 33 items evaluation (0, 1 or 2 points in each item) and results in an overall functional score. Range: 0-66, with a higher score reflecting better performance. No sub-scores will be used.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	up to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Acute flaccid paresis (AFP) at onset, and
Enterovirus D-68 polymerase chain reaction (PCR) positive in any specimen in a timely sample (+/- 3 weeks from onset of paresis), and
Age <18 years at onset, and
Magnetic resonance imaging (MRI) of spine and brain at onset with signs of myelitis.

Exclusion Criteria:

Major trauma
central nervous system (CNS) malignancy
Bleeding or infarctions in CNS
Previous demyelinating disease
Other infections cause of myelitis is more likely
Patient and/or legal guardian is not able/willing to sign the consent form

Contacts and Locations

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): NCT03499366

Contacts

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Contact: Anette Ramm-Pettersen, MD, PhD	0047 23070000	arammpet@ous-hf.no

Locations

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Norway
Oslo University Hospital	Recruiting
Oslo, Norway
Contact: Helle CV Pfeiffer, MD. PhD +47 23076182 helvie@ous-hf.no

Sponsors and Collaborators

Oslo University Hospital

University Medical Center Groningen

National Health Service, United Kingdom

Investigators

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Study Chair:	Anette ramm-Pettersen, MD, PhD	Head of department

More Information

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Responsible Party:	Helle Cecilie Viekilde Pfeiffer, Researcher, Pricipal investigator, PhD, Department of Child Neurology, Oslo University Hospital
ClinicalTrials.gov Identifier:	NCT03499366
Other Study ID Numbers:	2017/2123
First Posted:	April 17, 2018 Key Record Dates
Last Update Posted:	May 11, 2018
Last Verified:	May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

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

Keywords provided by Helle Cecilie Viekilde Pfeiffer, Oslo University Hospital:


enterovirus D68 AFP AFM	EV-D68 acute flaccid myelitis acute flaccid paresis

Additional relevant MeSH terms:

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Enterovirus Infections Myelitis Hemiplegia Paraplegia Quadriplegia Infections Paralysis Neurologic Manifestations	Nervous System Diseases Picornaviridae Infections RNA Virus Infections Virus Diseases Central Nervous System Infections Central Nervous System Diseases Spinal Cord Diseases

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