Skip to content

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

A randomised controlled trial examing the efficacy of Milrinone in reducing mortality in enterovirus 71-induced pulmonary oedema and/or neurogenic shock

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN76926623
Enrollment
Unknown
Registered
2010-09-02
Start date
2007-06-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

The eligible enrolled patients were randomized to receive either 1. Group A: medical (milrinone) treatment: Milrinone (Primacor®) was administered to the subjects who met the study criteria. The drug
dosage range of 0.35-0.55ug/kg/min
titrate dose to effect. Therapy was continued for 72 hours. 2. Group B: conventional standard management (supportive acre without milrinone treatment). All the enrolled subjects received standard med

Sponsors

National Health Research Institutes (NHRI) (Taiwan)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
To assess the efficacy of Milrinone as evaluated by the 1-week mortality in EV71 infected children with pulmonary oedema and/or neurogenic shock. 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.

Countries

Viet Nam

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026