Intravenous dexamethasone versus oral glycerol versus placebo in reducing auditory sequelae of childhood bacterial meningitis

ISRCTN	ISRCTN35932399
DOI	https://doi.org/10.1186/ISRCTN35932399
Protocol serial number	1
Sponsor	Alfred Kordelin Fund (Finland)
Funders	Alfred Kordelin, Päivikki and Sakari Sohlberg, and Sigfird Jusélius Funds (Finland), GlaxoSmithKline company (in initial phase) (Finland)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Heikki Peltola
Scientific

HUCH Hospital for Children and Adolescents
Helsinki
00029
Finland

Email	heikki.peltola@hus.fi

Primary study design	Interventional
Study design	Prospective randomised double-blind placebo-controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	Estudio GLI
Study objectives	Oral glycerol (GLY) may be at least as efficaceous as parenteral dexamethasone (DXM) in reducing auditory and other sequealae caused be bacterial meningitis of childhood.
Ethics approval(s)	Ministério da Saude, Comissão Nacional de Ética em Pesquisa - CONEP (ref: Parecer No. 1137/2001, Registro CONEP 2339), approval date: Oct. 2, 2001.
Health condition(s) or problem(s) studied	Bacterial meningitis
Intervention	Adjuvant medication with intravenous DXM, oral GLY, both, or neither agent. 4 arms: Arm 1: DXM + placebo (PLA) Arm 2: DXM + GLY Arm 3: GLY + PLA Arm 4: PLA + PLA
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Dexamethasone, glycerol
Primary outcome measure(s)	1. Death 2. Severe neurological sequelae 3. Hearing impairment
Key secondary outcome measure(s)	Composite endpoints: 1. Severe neurological sequelae or death 2. Subanalysis on Hib meningitis with or without prior antimicrobials
Completion date	31/12/2003

Participant type(s)	Patient
Age group	Child
Lower age limit	2 Months
Upper age limit	16 Years
Sex	All
Target sample size at registration	704
Key inclusion criteria	Children at age two months to 16 years in whom bacterial meningitis was diagnosed and treated in the Institutions
Key exclusion criteria	1. Recent head injury 2. Previous neurosurgery 3. Neurological diseases 4. Immunosuppression 5. Known hearing impairment 6. More than one dose of parenteral anti-microbial
Date of first enrolment	26/12/1996
Date of final enrolment	31/12/2003

HUCH Hospital for Children and Adolescents

Helsinki
00029
Finland

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	15/11/2007	Yes	No
Results article	results	01/01/2009	Yes	No
Results article	results	01/01/2010	Yes	No