Investigating the effect of pasteurized donor human milk in plastic and glass containers on the level of some hormones and anthropometric indexes in preterm neonate in neonatal intensive care units
Determining the effect of pasteurized human milk in plastic and glass containers on the level of some hormones and anthropometric indicators of preterm neonates
Design
A two-group randomized clinical trial
Settings and conduct
After approving the project, the researcher went to Shahid Beheshti and Al-Zahra hospitals, and based on inclusion criteria, samples were allocated to two intervention and control groups. Then the neonate's feeding continues for 4 weeks using donated milk that has been pasteurized in two containers. After that, a request for tests (estrogen and growth hormones, immunoglobulin A) is given after recording the neonatologist order in the neonate's file. Evaluation of thyroid hormone level in preterm neonate is one of the routine screening cases and the results of which will be used in the present study. The evaluation of anthropometric index will be done by the researcher under the same conditions.
Participants/Inclusion and exclusion criteria
inclusion criteria
neonates 26-32 weeks of pregnancy,Don't have life-threatening congenital abnormalities,Do not have chromosomal and asphyxia disorders,neonates who have at least 70% of their nutrition with donor milk during 24 hours,neonates who received donor milk up to 4 weeks after birth,Do not have a positive blood culture at the beginning of hospitalization.
exclusion criteria
Transferring the neonate to different hospitals from the research environment,Death of a neonate,Parents' refusal to participate in the study,Hospitalization period less than 4 weeks
Intervention groups
Preterm neonates receiving donor milk in a plastic and glass container
Main outcome variables
estrogen and growth hormones, immunoglobulin A, ,Thyroid hormone, anthropometric index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200714048101N1
Registration date:2024-01-04, 1402/10/14
Registration timing:prospective
Last update:2024-01-04, 1402/10/14
Update count:0
Registration date
2024-01-04, 1402/10/14
Registrant information
Name
Zeinab Hemati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7624
Email address
z.hemate@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of pasteurized donor human milk in plastic and glass containers on the level of some hormones and anthropometric indexes in preterm neonate in neonatal intensive care units
Public title
Investigating the effect of the type of containers used in the human milk pasteurization process on preterm neonate
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
neonates 26-32 weeks of pregnancy
Does not have life-threatening congenital anomalies (digestive, cardiac, neurological...).
Do not have chromosomal disorders.
Do not have asphyxia.
Neonates who are fed at least 70% by donor human milk during 24 hours.
Breast milk that has not been pasteurized for more than 72 hours since leaving the refrigerator at a temperature of 4 degrees Celsius.
Donor milk that has not been stored for more than 1 month in the freezer at -20 degrees Celsius.
donor milk that has been used up to 48 hours after leaving the frozen state.
Neonates who have received donor milk up to 4 weeks after birth.
Do not have a positive blood culture at the beginning of hospitalization.
Exclusion criteria:
Transferring the neonate to different hospitals from the research environment
Death of a neonate
Parents' refusal to participate in the study
Hospitalization period less than 4 weeks
Age
From 28 days old to 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
124
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are allocated to two interventions (plastic storage container) and control (glass storage container) groups based on the random permutation block method. Random sequence is generated using Blockrand package and R software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
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 Jerib street, faculty of nursing and midwifery
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-12-31, 1402/10/10
Ethics committee reference number
IR.MUI.NUREMA.REC.1402.165
Health conditions studied
1
Description of health condition studied
preterm neonates feeding with donor human milk
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Estrogen
Timepoint
four weeks after feeding
Method of measurement
laboratory results
Secondary outcomes
1
Description
Estrogen, growth and thyroid hormones, immunoglobulin A, anthropometric index
Timepoint
four week after feeding
Method of measurement
laboratory results
Intervention groups
1
Description
Intervention group: neonates receiving donor milk in a plastic container
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra and Shahid Beheshti hospitals
Full name of responsible person
Dr Zeinab Hemati
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences, School of Nursing and Midwifery
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7624
Email
z.hemate@gmail.com
2
Recruitment center
Name of recruitment center
Al-Zahra and Shahid Beheshti hospitals
Full name of responsible person
Dr Zeinab Hemati
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences, faculty of Nursing and Midwifery
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7624
Email
z.hemate@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Asgari
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences, faculty of Nursing and Midwifery
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7624
Email
z.hemate@gmail.com
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
Dr Zeinab Hemati
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hazar Jarib Street, Isfahan University of Medical Science, Nursing and Midwifery College
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
009837927624
Email
z.hemate@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
nastaran hassanvand
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences, faculty of Nursing and Midwifery
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 66 3252 5491
Email
n.hassanvand75@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
nastaran hassanvand
Position
MSc Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences, faculty of Nursing and Midwifery
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 66 3252 5491
Email
n.hassanvand75@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
Information about the outcome of the study
When the data will become available and for how long
After finishing the study
To whom data/document is available
Researchers in the field of neonates
Under which criteria data/document could be used
Using the results in other studies by mentioning the reference
From where data/document is obtainable
nastaran hassanvand
What processes are involved for a request to access data/document