Comparison of breastfed infants with breast milk + infant formula during the first days of life in terms of infant jaundice(icter), dehydration and hospitalization of term infants weighing more than 2500 in Kowsar Hospital
Design
Clinical trial with control group, with parallel, randomized groups, on 118 patients. Excel software rand function was used for randomization.
Settings and conduct
The study was performed in Kosar Hospital in Qazvin in the first 4 months of 1401 on term infants weighing more than 2500 grams and less than ten days old who are close to their mother and breastfeeding is started and followed up to ten days.
Participants/Inclusion and exclusion criteria
In this study, all term infants weighing more than 2500 grams are included in the study
Exclusion criteria:
1. Maternal dissatisfaction with formula feeding
2. Mothers who are unable to breastfeed their babies due to medical issues
3. Infants who need to be hospitalized at birth due to congenital diseases that have been identified before or during birth, etc.
Intervention groups
Term infants over 2500 grams and under ten days
Main outcome variables
Reduce the average length of hospital stay
Baby weight loss
Jaundice (neonatal jaundice)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210314050695N1
Registration date:2022-02-05, 1400/11/16
Registration timing:prospective
Last update:2022-02-05, 1400/11/16
Update count:0
Registration date
2022-02-05, 1400/11/16
Registrant information
Name
Marziyeh Karimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3365 3199
Email address
m.karimi.681010@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-21, 1401/01/01
Expected recruitment end date
2022-08-22, 1401/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of exclusive breast milk and breast milk with formula feed in incidence of Icter –admission and dehydration in term neonatal over 2500 gr
Public title
Study on the formula effect in the reduction of Icter admission
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
In this study, entrance criteria goes for all the infants holding more than 2500 grams weight
Exclusion criteria:
Dissatisfaction of mother to feed the infant with formula
Mothers, whom can not breath feed their infants because of medical issues
Infants, whom upon their birth require admission in hospital units because of their congenital disease (before or after the birth is diagnosed)
Age
From 2 days old to 10 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
118
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization
unit of randomization : individual
tools of randomization : random numerical table
Random number table is a set of numbers that are produced without a specific pattern or order and in a completely random manner and has become a table. In order to use the random number table, we must first preset the table to read the numbers (for example, up, down, left or right), the second assumption is to consider numbers for different groups, for example, even numbers for Group 1 intervention. And odd numbers for group 2 intervention
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not 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
Street address
Felestin Ave; Qods square ; Qods hospital
City
Qazvin
Province
Qazvin
Postal code
3415914595
Approval date
2020-10-24, 1399/08/03
Ethics committee reference number
99000049
Health conditions studied
1
Description of health condition studied
Neonatal jaundice
ICD-10 code
P59.9
ICD-10 code description
Neonatal jaundice, unspecified
Primary outcomes
1
Description
Reduce hospitalization or non-hospitalization due to neonatal jaundice / prevent infant weight loss
Timepoint
Daily up to ten days
Method of measurement
tcb (transcutaneus bilirubinometer)
Secondary outcomes
empty
Intervention groups
1
Description
Control group:Infants who are exclusively breastfeed
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
marziyeh karimi
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No . 17 fahim alley 4 , mosayeb moradi ave, nokhbegan blvd . qazvin town
City
qazvin
Province
Qazvin
Postal code
3414967888
Phone
+98 28 3365 3199
Email
m.karimi.681010@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
marziyeh karimi
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
qods hospital . qods squre , qazvin town
City
Qazvin
Province
Qazvin
Postal code
3414967888
Phone
+98 28 3365 3199
Email
m.krimi.681010@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
marziyeh karimi
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Qods children hospital
City
Qazvin
Province
Qazvin
Postal code
3415914595
Phone
+98 28 3333 4809
Email
m.karimi.681010@gmail.com
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
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentifiable individuals
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
It will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
In order to inform the general public and use in other texts and research
From where data/document is obtainable
Refer to Qazvin University of Medical Sciences Research and Development Center
What processes are involved for a request to access data/document
After referring to the research and development unit of Qazvin University of Medical Sciences and submitting a request for access to the data, they can follow up their application within the specified working time.