Comparison of the effect of injectable and oral fluconazole with oral Nystatin in the prevention of fungal infections in preterm infants
Design
A clinical trial with parallel groups, one-blind, randomized (permuted block randomization), phase 3 on 50 newborns, using www.sealedenvelope.com for
for randomization
Settings and conduct
This study is performed in the NICU of Alzahra Hospital in Tabriz. Newborns are randomly assigned to two groups. In the first group, newborns receive injectable or oral fluconazole. In the second group, newborns receive oral nystatin. In this study, the subjects did not know the type of drug received.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Premature newborns with gestational age less than 32 weeks, Newborn in the age range of 0 to 3 days, Birth weight less than 1500 gr
Parents' consent to participate in the study
Exclusion Criteria: Neonates with congenital anomalies, Newborns with shock
Intervention groups
In the first intervention group, newborns receive injected fluconazole (manufactured by Sina Daru, Iran) at a dose of 3 mg/kg twice a week and in case of peripheral or central venous rupture, continue with oral fluconazole 6 mg/kg twice a week for four weeks.
In the second intervention group: newborns receive oral nystatin (manufactured by Emad Darman Pars, Iran) in the amount of one hundred thousand units (1 ml) as a suspension every eight hours for four weeks.
Main outcome variables
Fungal infections
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210908052412N1
Registration date:2021-10-27, 1400/08/05
Registration timing:registered_while_recruiting
Last update:2021-10-27, 1400/08/05
Update count:0
Registration date
2021-10-27, 1400/08/05
Registrant information
Name
Leila Asgarzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2304 6253
Email address
asgarzadeh.l@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-10, 1400/03/20
Expected recruitment end date
2021-11-11, 1400/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Fluconazole in comparison with Nystatin in the prevention of fungal infections in very low birth weight infants
Public title
Efficacy of Fluconazole in comparison with Nystatin in the prevention of fungal infections in very low birth weight infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Premature newborns with gestational age less than 32 weeks
Newborn in the age range of 0 to 3 days
Birth weight less than 1500 gr
Parents' consent to participate in the study
Exclusion criteria:
Neonates with congenital anomalies
Newborns with shock
Age
From 1 day old to 3 days old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the block randomization method is used with blocks of sizes six and four. The website https://www.sealedenvelope.com is used to create a randomization list. The blocks are randomly selected using this website and given to a researcher who is not involved in choosing the type of drug. Each random chain generated contains a unique code for concealment. The drug regimen is placed in envelopes according to random chains, and after sealing it on the envelopes, the specific number created by the site is written and the envelopes are randomly placed in a box. a box.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, only newborns are blind (due to the condition of the infant and the parents do not know what drug is given to the infant) and do not know the type of medication received.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
3rd Floor, Central Building, Azadi St, Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2021-05-03, 1400/02/13
Ethics committee reference number
IR.TBZMED.REC.1400.144
Health conditions studied
1
Description of health condition studied
Fungal Infections, Premature
ICD-10 code
P37.5
ICD-10 code description
Neonatal candidiasis
Primary outcomes
1
Description
Fungal infections
Timepoint
Baseline and end of study (after 4 weeks)
Method of measurement
Bactec, cerebrospinal fluid (CSF) or urine culture
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Receiving injectable fluconazole (made by Sina Daru, Iran) at a dose of 3 mg/kg twice a week and in case of peripheral or central vein rupture, continue with oral fluoxonazole 6 mg / kg twice a week for 4 weeks .
Category
Treatment - Drugs
2
Description
Intervention group: Receiving oral nystatin (Emad Darman Pars, Iran) 100,000 units (1 ml) in suspension every eight hours for four weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Leila Asgarzadeh
Street address
Artesh Street, Alzahra Hospital,
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3553 9161
Email
dr.l.asgarzadeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiei
Street address
3rd Floor, Central Building, Tabriz University of Medical Science, Golgasht St,
City
Tabriz
Province
West Azarbaijan
Postal code
5166616471
Phone
+98 41 3336 3767
Email
Samiei.moh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Leila Asgarzadeh
Position
Fellow
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No. 23, Forozanfar St, Gisha St
City
Tehran
Province
Tehran
Postal code
1446754471
Phone
0098 23046253
Email
dr.l.asgarzadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Leila Asgarzadeh
Position
Fellow
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No. 23, Forozanfar St, Gisha St
City
Tehran
Province
Tehran
Postal code
1446754471
Phone
+98 21 2304 6253
Email
dr.l.asgarzadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Leila Asgarzadeh
Position
Fellow
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No. 23, Forozanfar St, Gisha St
City
Tehran
Province
Tehran
Postal code
1446754471
Phone
0098 23046253
Email
dr.l.asgarzadeh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available