systemic fungal infections is one of the most common causes of the mortality especially in preterm neonates . The aim of this study is the evaluation of the effect of Intravenous Fluconazole prophylaxis on clinical outcome of preterm neonates during hospitalization .
Methods and materials: In a nonrandomized , single-blind clinical trial , without placebo 100 preterm neonates with a birth weight less than 1250 g who had no major congenital anomalies , and alive until three days after birth , enrolled into the study. 50 neonates selected as case group , and 50 neonates as control group alternatively . During hospitalization , first group received 6-weeks treatment with 3mg/kg dose of fluconazole as once every 3 days in first 2 weeks , once every 2 days in second 2 weeks and every day in third 2 weeks and NICU standard care( including IV line , antibiotics and respiratory care ) , but control group received only NICU standard care. The outcomes include duration of mechanical ventilation , in-hospital mortality and the time of hospitalization . The data from two groups were analyzed using appropriate statistical tests .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014051411499N1
Registration date:2014-08-03, 1393/05/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-08-03, 1393/05/12
Registrant information
Name
Abdollah Jannatdoust
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1526 2250
Email address
jannatdousta@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2013-08-24, 1392/06/02
Expected recruitment end date
2014-02-24, 1392/12/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Intravenous Fluconazole prophylaxis on clinical outcome of preterm neonates during hospitalization
Public title
Intravenous Fluconazole prophylaxis in preterm neonates
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria :
birth weight less than 1250 g
Exclusion criteria:
1- major congenital anomalies
2- death in three days of life
Age
From 1 day old to 29 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Research Vice- Canceller of Tabriz University of Medical Sciences
Street address
3 rd floor , 2nd central building of TBZmed , Golgasht Ave.
City
Tabriz
Postal code
5174816671
Approval date
2013-08-21, 1392/05/30
Ethics committee reference number
9279
Health conditions studied
1
Description of health condition studied
Candidial sepsis
ICD-10 code
P37.5
ICD-10 code description
Neonatal candidiasis
Primary outcomes
1
Description
Hospital stay days
Timepoint
measured at discharge
Method of measurement
in hospital days
2
Description
Assisted ventilation duration in days
Timepoint
measured at discharge
Method of measurement
days under assisted ventilation
Secondary outcomes
1
Description
Mortality Rate
Timepoint
after death
Method of measurement
if died
Intervention groups
1
Description
Intravenous fluconazole 3mg/kg for 6-weeks treatment with 3mg/kg dose of fluconazole as once every 3 days in first 2 weeks, once every 2days in second 2 weeks and every day in third 2 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Hasan Soleinpour
Street address
Artesh ave.Baghshomal crossroad
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Vice-Canceller of Tabriz University of Medical Sciences
Full name of responsible person
Abdollah Jannatdoust
Street address
Alzahra hospital , Baghshomal Crossroad
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice-Canceller of Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abdollah Jannatdoust
Position
Assistant professor/Neonatology subspecialist
Other areas of specialty/work
Street address
Alzahra Hospital , Artesh Ave.
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
+98 41 1526 2280
Email
jannatdousta@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abdollah Jannatdoust
Position
Assistant professor/neonatology subespecialist
Other areas of specialty/work
Street address
Alzahra Hospital , Artesh Ave.
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
+98 41 1526 2280
Email
jannatdousta@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abdollah Jannatdoust
Position
Neonatology Subspecialist
Other areas of specialty/work
Street address
Alzahra Hospital , Artesh Ave.
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
jannatdousta@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)