Protocol summary

Study aim
Oral nystatin prophylaxis in preventing Candida colonization
Design
A clinical trial with a control group, not blinded, randomized by random sequencing on 106 patients.
Settings and conduct
All infants born in Ayatollah Mousavi Hospital in Zanjan or admitted to other hospitals in the province who are in the first 72 hours of life and have a gestational age less than 32weeks or birth weight less than 1500gram , they enter one of the control or intervention groups and then, based on the prepared checklist, information about the variables is recorded and evaluated.
Participants/Inclusion and exclusion criteria
Infant born in the first 72 hours of life have a gestational age less than 32 weeks or a birth weight less than 1,500 grams will be examined after obtaining written and informed consent from the parents.Infants who have severe abnormalities or chromosomal abnormalities, severe sepsis, Congenital heart disease , Intraventricular hemorrage , disseminated intravascular coagulation ,trush ,diseases requiring surgery, fungal infections proven or parental disagreement are excluded from the study.
Intervention groups
Infants in the nystatin group receive 100,000 UI / ml, 0.5 ml intraorally and 0.5 ml via the urogastric tube three times a day from the nystatin oral suspension of Emad Darman Pars Company. The control group did not receive antifungal prophylaxis. After one week, it is prepared from the oral and rectal mucosa by sterile swap method and sent to the laboratory for smear, culture and analysis.
Main outcome variables
Gestational age, birth weight,Type of delivery, prolonged premature rupture of the Membrane, use of broad-spectrum antibiotics , receiving invasive ventilation,Duration of receiving invasive ventilation,Oral culture and smear according to the candida, rectal culture and smear according to the candida,

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201222049802N2
Registration date: 2021-03-15, 1399/12/25
Registration timing: prospective

Last update: 2021-03-15, 1399/12/25
Update count: 0
Registration date
2021-03-15, 1399/12/25
Registrant information
Name
Asghar Marzban
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3313 1292
Email address
drmarzban@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2021-05-05, 1400/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Oral nystatin prophylaxis to prevent of candida colonization in premature infant with weigth less than 1500 gram in Neonatal Intensive care Unit
Public title
Oral nystatin prophylaxis to prevent of candida colonization in premature infant with weigth less than 1500 gram in Neonatal Intensive care Unit
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
infants born in the first 72 hours of life birth weight less than 1500gram gestational age less than 32 weeks who are hospitalized in the neonatal intensive care unit
Exclusion criteria:
severe abnormalities chromosomal abnormalities severe sepsis Congenital heart disease Intraventricular hemorrage disseminated intravascular coagulation Thrush congenital disorders requiring surgery Fungal infections proven by blood or urine culture require treatment with appropriate antifungal drugs such as amphotericinCommunity Verified icon Parents' dissatisfaction with the infant's participation in the study
Age
From 1 day old to 3 days old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 106
More than 1 sample in each individual
Number of samples in each individual: 2
One week after birth, a swab is prepared from the oral and rectal mucosa for smear and culture of the fungus and sent to the laboratory of Mousavi Hospital in Zanjan for analysis.
Randomization (investigator's opinion)
Randomized
Randomization description
Random sequence through a table of random numbers
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Infants are randomly divided into one of two groups, the nystatin group and the control group. Infants in both groups are similar in age, sex, gestational age, weight, and other anthropometric findings. Infants in the nystatin group receive 100,000 UI / ml, 0.5 ml intraorally and 0.5 ml via the urogastric tube three times a day from the nystatin oral suspension of Emad Darman Pars Company. The control group did not receive antifungal prophylaxis.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Ayatollah Mousavi Hospital, Above Shahid Sabouti Boulevard, Gavazang Road, Zanjan, Iran.
City
Zanjan
Province
Zanjan
Postal code
4513956183
Approval date
2020-12-16, 1399/09/26
Ethics committee reference number
IR.ZUMS.REC.1399.330

Health conditions studied

1

Description of health condition studied
candida colonization
ICD-10 code
P37.5
ICD-10 code description
Neonatal candidiasis

Primary outcomes

1

Description
Gestetional age
Timepoint
Week
Method of measurement
The number of weeks that have elapsed since the last menstrual period.

2

Description
Birth weight
Timepoint
Birth
Method of measurement
Weighing the baby

3

Description
Type of delivery(Natural vaginal delivery or cesarean section)
Timepoint
at birth
Method of measurement
Get a history and file

4

Description
Premature rupture of the membrane
Timepoint
rupture of the membrane>18houres
Method of measurement
Get a history and file

5

Description
Use of broad-spectrum antibiotics (third-generation cephalosporins and carbapenems)
Timepoint
One week after birth
Method of measurement
Get a history and file

6

Description
Receive invasive respiratory ventilation
Timepoint
One week after birth
Method of measurement
Get a history and file

7

Description
oral culture and smear for fungi
Timepoint
one week after birth
Method of measurement
laboratory report

8

Description
rectal culture and smear for fungi
Timepoint
One week after birth
Method of measurement
laboratory report

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group: Infants born in Ayatollah Mousavi Hospital in Zanjan or admitted from other hospitals in the province who are in the first 72 hours of life and are admitted to the neonatal intensive care unit and have a gestational age less than 32w or birth weight less than 1500gr, From the oral suspension of nystatin of Emad Darman Pars Company, they receive 100,000 UI / ml, 1ml (0.5 ml into the oral cavity and 0.5 ml through the urogastric tube) three times a day. The mouth and rectum are prepared for smear and fungal culture and sent to the laboratory of Mousavi Hospital in Zanjan for analysis.
Category
Prevention

2

Description
Control group: Control group: Intervention group: Infants born in Ayatollah Mousavi Hospital in Zanjan or admitted from other hospitals in the province who are in the first 72 hours of life and are hospitalized in the neonatal intensive care unit and have a gestational age less than 32w or birth weight less than 1500gr, the control group does not receive antifungal prophylaxis. After a week, a swab is prepared from the oral mucosa and rectum for smear and culture of the fungus and sent to the laboratory of Mousavi Hospital in Zanjan for analysis.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Mousavi hospital
Full name of responsible person
Samie Ahadi
Street address
Ayatollah Mousavi Hospital, Gavazang Road, Above Shahid Sabouti Boulevard, zanjan, iran.
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3342 0651
Fax
+98 24 3313 1203
Email
Mousavihospital@zums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Alireza Shoghli
Street address
Ayatollah Mousavi Hospital, Above Shahid Sabouti Boulevard, Gavazang Road, zanjan, iran.
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3342 0651
Fax
+98 24 3313 1203
Email
Mousavihospital@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Zanjan University Of Medical Science
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
Zanjan University of Medical Sciences
Full name of responsible person
Asghar Marzban
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Ayatollah Mousavi Hospital, Gavazang Road, Above Shahid Sabouti Boulevard, zanjan, iran.
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3342 0651
Email
Drmarzban@zums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Asghar Marzban
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Ayatollah Mousavi Hospital, Gavazang Road, Above Shahid Sabouti Boulevard, zanjan, iran.
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3342 0651
Email
Drmarzban@zums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Asghar Marzban
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Ayatollah Mousavi Hospital, Gavazang Road, Above Shahid Sabouti Boulevard, zanjan, iran.
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3342 0651
Email
Drmarzban@zums.ac.ir

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
Undecided - It is not yet known if there will be a plan to make this available
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
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