Milrinone treatment versus conventional standard management for children with enterovirus 71-induced pulmonary oedema and/or neurogenic shock

Completed

• Conditions: Enterovirus 71-induced pulomnary oedema and/or neurogenic shock; Infections and Infestations; Viral infection of unspecified site

• Registration Number: ISRCTN76926623
• Lead Sponsor: ational Health Research Institutes (NHRI) (Taiwan)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-02
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1. Paediatric patients, EV71 brainstem encephalitis with pulmonary oedema and/or neurogenic shock.
2. EV71 infection was confirmed by isolation of virus or molecular test (real-time PCR) from at least one site (throat swab, stool swab, cerebrospinal fluid (CSF) or other specimens), or serologic assay (neutralizing antibody titre).
3. Stage Definitions
Stage IIIB, cardiopulmonary collapse with the occurrence of pulmonary oedema and/or neurogenic shock.

Exclusion Criteria

1. History of congenital heart disease
2. History of pulmonary disorder
3. Known or suspected impairment of immunologic function
4. Known hypersensitivity to any component of Milrinone
5. Prior administration of Milrinone
6. Any condition, which, in the opinion of the investigator, may interfere with the evaluation of the study objectives.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the efficacy of Milrinone as evaluated by the 1-week mortality in EV71 infected children with pulmonary oedema and/or neurogenic shock.<br><br>Each enrolled subject was followed with a standard critical care protocol until he or she was discharged from hospital or expired. Evaluation was performed when necessary for all the enrolled subjects during their hospital stays.