Comparison of the effect of Au-Da-libur water and placebo on infections and falling time of umbilical cord
Design
A clinical trial has been conducted with randomized control and intervention groups. The sample size consists of 80 neonates. Individuals will be randomly assigned to one of the two groups by using the table of random numbers.
Settings and conduct
The present study will be conducted at Kosar Hospital of Qazvin. In the intervention group, Au-Da-libur water will be used (3 times/day). Distilled water was used in the placebo group. The length time of the umbilical cord falls and the infection rate will be recorded. Finally, the data will be entered into SPSS software and statistical tests will be done.
Participants/Inclusion and exclusion criteria
Healthy newborns
Gestational age ≥35 weeks
Birth weight ≥ 2.5 kg
Intervention groups
Treatment group: treatment with Au-Da-libur water
Placebo group: treatment with distilled water
Main outcome variables
Time of umbilical cord falling down (days)
Infection rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190122042456N1
Registration date:2019-05-06, 1398/02/16
Registration timing:prospective
Last update:2019-05-06, 1398/02/16
Update count:0
Registration date
2019-05-06, 1398/02/16
Registrant information
Name
Samane Lashgari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3332 8708
Email address
s.lashgari@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Au-Da-libur water and placebo on infections and falling time of umbilical cord
Public title
The effect of Au-Da-libur water on falling time of umbilical cord
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy newborns
Gestational age ≥35 weeks
Birth weight ≥ 2.5 kg
Exclusion criteria:
The presence of underlying or acquired illness
Medical interventions on the newborn
Age
From 1 day old to 1 day old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In the present study, individuals will be randomly assigned to one of the two intervention and control groups by using the table of random numbers.
There is no precondition for assigning individuals to groups.
The randomization unit is Individual. Every participant will have an equal chance of being in each of the groups.
Allocation concealment samples are done by the people of the center that they do not have any information about the researcher's aim.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Murtaza Habibi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Qods Sq., Shahid beheshti Blvd., Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3415945951
Phone
+98 28 3333 4807
Email
mhabibi@qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Samaneh Lashgari
Position
M.D. student
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Qods Sq., Shahid Bahonar Blvd., Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 7006
Email
s.lashgari@gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Samaneh Lashgari
Position
M.D. student
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Qods Sq., Shahid Bahonar Blvd., Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 7006
Email
s.lashgari@qums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All data is published in Excel format without mentioning patient names.
When the data will become available and for how long
The data will be released from July 2022 for one month.
To whom data/document is available
Medical students, researchers at medical research centers and professors of medical sciences universities
Under which criteria data/document could be used
Comparison of data with other experimental data is allowed. If the article is published, mention should be made of the names of the persons who own the data.
From where data/document is obtainable
The main executor of clinical trial
What processes are involved for a request to access data/document
Submitting a request by the applicant and submitting a letter from the authorized centers.