Assessing the effects of early initiation of colostrum on the outcomes in premature infants
Design
A prospective randomized clinical trial with a control group, phase 3, which is conducted on 112 premature infants (32 weeks and less). The samples (into two groups) will be assigned to two groups by permuted block randomization.
Settings and conduct
Eligible premature neonates admitted to Amir Al-Momenin hospital in Semnan will be assigned to the intervention or control group and are examined after receiving the intervention. Then the neonates in both groups will be examined in terms of reducing early onset sepsis and reducing cases with late onset sepsis.
Participants/Inclusion and exclusion criteria
112 premature neonates with a gestational age at birth less than 32 weeks and a birth weight of 1500 grams or less, without any congenital anomaly such as tracheoesophageal fistula and the presence of asphyxia at birth, as well as no contraindication for breastfeeding, will be enrolled in the study and assigned into two groups. The two groups are matched based on the gestational age at birth.
Intervention groups
Total parenteral nutrition (TPN) method is used for primary feeding in both intervention and control groups. In the intervention group, in addition to TPN, colostrum will be taken immediately after birth and in the first hours of the newborn's admission in the NICU, 0.2 ml was given on each side in the oropharyngeal route every 3 hours up to 48 hours. The control group will receive only TPN.
Main outcome variables
The primary outcome variable is decreasing of early onset sepsis incidence and the secondary outcome variable is decreasing of late onset sepsis cases.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151020024625N20
Registration date:2024-06-02, 1403/03/13
Registration timing:prospective
Last update:2024-06-02, 1403/03/13
Update count:0
Registration date
2024-06-02, 1403/03/13
Registrant information
Name
Mehrdad Zahmatkesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3343 7844
Email address
mehrdadzahmatkesh@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2025-04-20, 1404/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effects of early initiation of colostrum for prevention of sepsis in premature infants
Public title
Effects of early initiation of colostrum on outcomes in preterm infants
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age at birth less than 32 weeks.
Birth weight greater than or equal to 1500 gram.
Exclusion criteria:
Contraindication for breastfeeding
APGAR score less than 5
Umbilical cord arterial pH less than 7 at the first hour of birth
Birth asphyxia.
Congenital gastrointestinal (GI) anomalies
Age
To 223 days old
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by using the permuted block technique with 16 blocks of 6 and 8 and neonates will be assigned to two groups. In this method, A represents group 1 and B represents group 2. The order of interventions A and B in the form of blocks from number 1 to 16 is determined by the statistical consultant and provided to the project researcher. The researcher selects the block number using a random number generator, and then the neonates are assigned to one of the two groups A or B based on the pre-specified order of the 6 or 8 blocks.
Blinding (investigator's opinion)
Single blinded
Blinding description
The datasheet is such that the name of the groups is not specified, and it is specified as the first and second group and will be provided to the statistical consultant.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Basidj Blvd.
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2024-01-29, 1402/11/09
Ethics committee reference number
IR.SEMUMS.REC.1402.259
Health conditions studied
1
Description of health condition studied
Early and late onset sepsis
ICD-10 code
P36
ICD-10 code description
Bacterial sepsis of newborn
Primary outcomes
1
Description
Early onset sepsis
Timepoint
Seven, and 14 days after initiation of the intervention.
Method of measurement
Laboratory tests including blood cultures and clinical examinations and the presence of symptoms such as fever, lethargy, and respiratory symptoms.
Secondary outcomes
1
Description
Late onset sepsis
Timepoint
21 days after initiation of the intervention and finally until start of normal nutrition and cessation of total parenteral nutrition (TPN).
Method of measurement
Laboratory tests including blood cultures and clinical examinations and the presence of symptoms such as fever, lethargy, and respiratory symptoms.
Intervention groups
1
Description
Intervention group: In the intervention group, in addition to TPN, the mother's colostrum is taken immediately after birth, and in the first hours of admission in the NICU, 0.2 ml of colostrum on each side in the oropharyngeal route are given by an insulin syringe without needle every 3 hours, up to 48 hours.
Category
Prevention
2
Description
Control group: Neonates in control group will be received only total parenteral nutrition.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Al Momenin hospital
Full name of responsible person
Soufia Arabpour
Street address
Shahid Moustafa Khomeini Bivd.
City
Semnan
Province
Semnan
Postal code
3519734731
Phone
+98 23 3346 0055
Email
sd7003577@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Majid Mirmohammadkhani
Street address
Basidj Blvd.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
majidmirmohammadkhani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Yalda Taghipour
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Neonatal-Perinatal Medicine
Street address
Shahid Moustafa Khomeini Blvd.
City
Semnan
Province
Semnan
Postal code
3519734731
Phone
+98 23 3346 0055
Email
Ya.taghipour20@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Yalda Taghipour
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shahid Moustafa Khomeini Blvd.
City
Semnan
Province
Semnan
Postal code
3519734731
Phone
+98 23 3346 0055
Email
Ya.taghipour20@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mehrdad Zahmatkesh
Position
Researcher
Latest degree
Bachelor
Other areas of specialty/work
Biostatistics
Street address
Amin Ave., Basij Blvd.
City
Semnan
Province
Semnan
Postal code
3519899558
Phone
+98 23 3142 2250
Email
mehrdadzahmatkesh@semums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data will be provided anonymously in the Excel file.
When the data will become available and for how long
Access date is 6 months after publishing the final.
To whom data/document is available
Access to the data will be possible for academic researchers.
Under which criteria data/document could be used
The data can be used for further studies and meta-analyses.
From where data/document is obtainable
Contact with the scientific responsible of the study via email.
What processes are involved for a request to access data/document
En After receiving of the request by e-mail, it will be sent at the latest the day after receiving the request.