FIC - Training in malaria research in Uganda

ISRCTN	ISRCTN13964268
DOI	https://doi.org/10.1186/ISRCTN13964268
Protocol serial number	N/A
Sponsor	Fogarty International Center (FIC) (USA)
Funder	Fogarty International Centre (FIC) (USA) (grant ref: TW007375)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Justus Byarugaba
Scientific

Makerere Univeristy
Faculty of Medicine
Department of Pediatrics and Child Health
P.O. Box 7072
Kampala
-
Uganda

Phone	+256 75 696 633
Email	byarugabaj@yahoo.com

Primary study design	Interventional
Study design	Randomised double blind clinical trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	FIC
Study objectives	The proportion of convulsions terminated by buccal midazolam is higher than the proportion of convulsions terminated by rectal diazepam in children.
Ethics approval(s)	Ethics approved received from: 1. The Makerere University Medical School Research and Ethics Review Board (Uganda) 2. National Council of Science and Technology Institutional Review Board (IRB) (Uganda) 3. University of California San Francisco Institutional Review Board (IRB) (USA)
Health condition(s) or problem(s) studied	Prolonged convulsions
Intervention	Rectal diazepam versus buccal placebo
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Midazolam, diazepam
Primary outcome measure(s)	Time taken to terminate convulsion within 10 minutes without re-occurence of the convulsion in an hour.
Key secondary outcome measure(s)	1. Time taken to re-occurence of convulsion after initial control 2. Time taken to terminate the convulsion within 10 minutes 3. Proportion of children who get respiratory depression within one hour after adminstration of the study drug
Completion date	20/05/2006

Participant type(s)	Patient
Age group	Child
Lower age limit	3 Months
Upper age limit	12 Years
Sex	All
Target sample size at registration	350
Key inclusion criteria	1. Age between 3 months to 12 years 2. Admission to Acute Care Unit during the study period 3. A child who presents to the Acute Care Unit with convulsions 4. Provision of informed consent to continue participation in the study
Key exclusion criteria	1. Documented evidence of having recieved parenteral anticonvulsant in the past 24 hours 2. Cessation of convulsion before adminstration of study drug 3. Parent/caretaker verbally declines to participate in the study
Date of first enrolment	20/11/2005
Date of final enrolment	20/05/2006

Makerere Univeristy

Kampala
-
Uganda

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	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/01/2008		Yes	No