Effect of early administration of oropharyngeal colostrum on immune status and common morbidities of premature infants with gestational age Less or equal 30 weeks and birth body weight Less or equal 1500 gram
Effect of early administration of oropharyngeal colostrum on immune status and common morbidities of premature infants
Design
Clinical trial with control group, with parallel groups, double-blind
Settings and conduct
60 children will be selected from Al-Zahra and Beheshti hospitals. The milk room nurse knows which baby should receive colostrum or distilled water. She puts the babys' nutrition with a large label containing the baby's name in the refrigerator and prescribes the specified content, every 3 hours, through the oropharynx for 72 hours. Oropharyngeal administration also begins as soon as possible during the first 36 hours after birth. A urine sample is taken from the baby before the first dose. The babysitter and data analyzer are blinded.
Participants/Inclusion and exclusion criteria
Inclusion:Infants less than or equal to 30 weeks old and weighing less than or equal to 1500 g,
Absence of major congenital malformations,
Apgar higher than 4 in the fifth minute of birth,
Exclusion:Lack of colostrum needed by infant mother,
Diagnosis of early sepsis with positive blood culture,
Need to continue receiving aminoglycoside after the first 96 hours of birth,
Mother's HIV infection,
History of maternal chorio amnionitis.
Intervention groups
Thirty infants in the intervention group received their maternal colostrum every 3 hours for 72 hour,the correct metod of breast feeding and the properties of colostrum were explained to mothers in one hour session. Thirty infant in the control group received ampoules containing 5 cc distilled water prepared by Shahid Ghazi Pharmaceutical Company every 3 hours for 72 hours. oropharyngeal administration was started as soon as possible during the first 36 hours after birth.
Main outcome variables
Urinary IgA Concentration, Duration of Complete Intestinal Nutrition, Prevalence of Necrotizing Enterocolitis, Hospitalization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171230038142N19
Registration date:2020-08-16, 1399/05/26
Registration timing:registered_while_recruiting
Last update:2020-08-16, 1399/05/26
Update count:0
Registration date
2020-08-16, 1399/05/26
Registrant information
Name
Khosro Tavakol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 9134
Email address
tavakol@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-05, 1398/12/15
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of early administration of oropharyngeal colostrum on immune status and common morbidities of premature infants with gestational age Less or equal 30 weeks and birth body weight Less or equal 1500 gram
Public title
Effect of early administration of oropharyngeal colostrum on immune status and common morbidities of premature infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Infants less than or equal to 30 weeks old and weighing less than or equal to 1500 g
Absence of major congenital malformations
Apgar higher than 4 in the fifth minute of birth
Exclusion criteria:
Unable to provide colostrum by the mother, to the extent required for study
Diagnosis of early sepsis with positive blood culture
Urinary Tract Infection
Need to continue receiving aminoglycoside after the first 96 hours of birth
Maternal HIV infection
History of maternal chorio amnionitis
Age
From 1 day old to 1 day old
Gender
Both
Phase
2-3
Groups that have been masked
Care provider
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
First, all mothers were asked to breastfeed as soon as possible and put it in a special sterile container. The nurse, who is familiar with the process, then takes the dishes from the mothers. The nurse, who is not present during the rest of the research, prepares colostrum syringes and distilled water, and each insulin syringe containing colostrum or distilled water is stamped with a large label that says the date of aggregation or distilled water and the baby's name. So that the content inside it is not clear and the neonatal nurse (clinical caregiver) does not understand and feeds each baby based on the syringe on which the baby's name is, and therefore is blinded in the process. Data analyzer is not aware of how to do the job.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jereyb Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2020-02-01, 1398/11/12
Ethics committee reference number
IR.MUI.MED.REC.1398.559
Health conditions studied
1
Description of health condition studied
Premature Infants
ICD-10 code
O42.019
ICD-10 code description
Preterm premature rupture of membranes, onset of labor within 24 hours of rupture, unspecified trimester
Primary outcomes
1
Description
Urinary IgA Concentration
Timepoint
Before the intervention, eighth day of birth, 15th day of birth
Method of measurement
Measurement of IgA concentration in urine samples using Turbidometry method
2
Description
The prevalence of necrotizing enterocolitis
Timepoint
During hospitalization
Method of measurement
Counting cases
3
Description
The prevalence of mortality
Timepoint
During hospitalization
Method of measurement
death count
4
Description
Duration of complete intestinal nutrition
Timepoint
During hospitalization
Method of measurement
Counting the days
5
Description
Duration of hospitalization
Timepoint
Duration of hospitalization
Method of measurement
Counting the days
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For infants in this group, a syringe containing colostrum taken from the milk of infants' own mothers (0.2 ml) is oropharyngeally administered on the left and right sides of their mouth mucosa slowly for at least 2 minutes every 3 hours. The mentioned procedure continues for 72 hours from the beginning of the intervention. Before each appointment, the nurse will make sure that no secretion requiring suction is in the infants' mouth and nose.
Category
Treatment - Drugs
2
Description
Control group: For infants in this group, a syringe containing distilled water (0.2 ml) is oropharyngeally administered on the left and right sides of their mouth mucosa slowly for at least 2 minutes every 3 hours. The mentioned procedure continues for 72 hours from the beginning of the intervention. Before each appointment, the nurse will make sure that no secretion requiring suction is in the infants' mouth and nose.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital of Isfahan
Full name of responsible person
Majid Mohammadi Zadeh
Street address
Al Zahra Hospital, Sufeh Street.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Fax
Email
mohammadizadehm_z@yahoo.com
2
Recruitment center
Name of recruitment center
Isfahan Shahid Beheshti Hospital
Full name of responsible person
Majid Mohammadi Zadeh
Street address
Pol Felezi, At the beginning of Motahari Street
City
Isfahan
Province
Isfehan
Postal code
81747-72248
Phone
+98 31 3234 6338
Fax
Email
mohammadizadehm_z@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Vice Chancellor for Research and Technology, Building No. 4, Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Fax
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Azadeh Jafari
Position
Consultant
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Al-Zahra Hospital, Sofah Boulevard.
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 0048
Email
jafari@pharm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Majid Mohammadi Zadeh
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Al-Zahra Hospital, Sofah Boulevard.
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
mohammadizadehm_z@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Neda Abrishami
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Biostatistics
Street address
Isfahan University of Medical Sciences, Hazar Jarib Street
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Fax
Email
dadepardaz2005@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
The information is shared two years after the results are published.
When the data will become available and for how long
The information is shared two years after the results are published.
To whom data/document is available
Doctors and pediatricians
Under which criteria data/document could be used
Comparison of the present method with another method or treatment
From where data/document is obtainable
Send mohammadizadehm_z@yahoo.com an email
What processes are involved for a request to access data/document