Investigating prognosis of early feeding with breastmilk-cells in premature infants
Design
Case group : Include 64 premature babies, with birth weight less than 1800 grams and can not tolerate their own mother breast milk.
Control group: This group will be fed according to the routine ward protocol.
They were selected randomly and by using special statistical tables. After an informative consent from parents.
Settings and conduct
This study will be done in Mahdieh Hospital and in the NICU ward. For the case group, we will ask the mothers to pump their milk and collected in a sterile tube with the supervision of trained personnel. This fresh milk will be centrifuged and the upper layer which contains fat and protein will be separated. The rest of the tube that contains breast milk cells will be fed by N.G.Tube or PO.
Participants/Inclusion and exclusion criteria
All premature infants born with birth weight less than 1800 g , with parental consent is entered into the study .
If the baby has severe congenital anomalies or severe and fatal illness, will be excluded from the study.
Intervention groups
Case group: Include infants unable to bear breast milk after birth. For this group, the breast milk is centrifuged and the separated cells are fed to the baby after separating the fat and protein layer. Breastfeeding begins as other infants, when they can tolerate the whole milk.
Control group: Include infants selected by statistical tables and breastfeeding will be started according to usual ward protocols.
Main outcome variables
In addition to demographic variables, age of breast feeding and feeding tolerance, and some complications like BPD,NEC, ROP... will be evaluated.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190228042868N1
Registration date:2019-05-25, 1398/03/04
Registration timing:registered_while_recruiting
Last update:2019-05-25, 1398/03/04
Update count:0
Registration date
2019-05-25, 1398/03/04
Registrant information
Name
Mohammad Kazemian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2292 2827
Email address
kazemianm@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating Prognosis of Early Feeding with Breast milk-Cells in Premature infants
Public title
Investigating Prognosis of Early Feeding with Breast milk-Cells in Premature infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All the neonates that were born with a birth weight less than 1800 grams
Exclusion criteria:
Parental dissatisfaction with the implementation of this study
Failure to prepare breast milk for various reasons
Congenital severe anomalies
The presence of any serious and fatal illness that is in conflict with life
Severe Prematurity (less than 25 weeks)
Age
From 1 day old to 90 days old
Gender
Both
Phase
2
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Randomized
Randomization description
According to statistical method : Block randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
We urge the mothers of both groups to express their own milk.This action will stimulate and secrete more milk for mothers in the coming days and is recommended.
Because the low-birth weight infants can not tolerate feeding in routine therapy, the extracted cells are given to the case group. As time goes on, nutrition will be started for both groups, based on the routine (clinical and special condition).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of shahid Beheshti University of Medical Sciences
Street address
Mofid Children Hospital, Shariati St.,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1546815514
Approval date
2018-11-29, 1397/09/08
Ethics committee reference number
IR.SBMU.RETECH.REC.1397.1287
Health conditions studied
1
Description of health condition studied
Necrotizing enterocolitis (NEC)
ICD-10 code
P77
ICD-10 code description
Necrotizing enterocolitis of newborn
2
Description of health condition studied
Bacterial sepsis of newborn
ICD-10 code
P36
ICD-10 code description
Bacterial sepsis of newborn
3
Description of health condition studied
Retinopathy of prematurity
ICD-10 code
H35.1
ICD-10 code description
Retinopathy of prematurity
4
Description of health condition studied
Bronchopulmonary dysplasia
ICD-10 code
P27.1
ICD-10 code description
Bronchopulmonary dysplasia originating in the perinatal period
Primary outcomes
1
Description
Duration of hospital stay
Timepoint
The whole period of admission is evaluated
Method of measurement
Based on observation and examination and questionnaire records.
2
Description
2-Comparison of the total feeding time in the newborn
Timepoint
From birth to full feeding
Method of measurement
Evidence available in the clinical file and based on the day
3
Description
Incidence of necrotizing enterocolitis
Timepoint
The disease occurs most of the time with the onset of nutrition and during the hospital stay.
Method of measurement
According to the "Bell's criteria"
4
Description
Time required for the respirator
Timepoint
Duration of treatment with respirator.
Method of measurement
Evidence available in the clinical file and based on the day
5
Description
Prevalence of retinopathy of prematurity
Timepoint
Ophthalmologic examination for all newborns will be done in about 1 month of age.
Method of measurement
It will be calcified according the extent of the vessels of the bottom of the eye.
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, feeding with lactating cells started by separating of the fat and protein layer. these neonate can not tolerate whole breast milk.
Category
Treatment - Other
2
Description
Control group: Babies who received routine nursing care and after a few days breastfeeding will be started.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdieh Maternity Hospital
Full name of responsible person
Kazemian Mohammad
Street address
Fadaeian Eslam ave.- Shoosh Squ.
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Fax
+98 21 5506 2627
Email
kazemianm@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zarghi Afshin
Street address
Next to Taleghani Hospital,Velengak, Chamran high way
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9888
Email
info@sbmu.ac.ac
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shafiee Rodsari Mohammad
Position
Sub-speciality resident
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Neonatal Health Research Center-Mofid Children Hospital - Shariati Ave.
City
Tehran
Province
Tehran
Postal code
1546815514
Phone
+98 21 2292 2827
Fax
+98 21 2292 2828
Email
leilashsh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Kazemianm Mohammad
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Neonatal Health Research Center-Mofid Children Hospital - Shariati Ave.
City
Tehran
Province
Tehran
Postal code
1546815514
Phone
+98 21 2292 2827
Fax
+98 21 2292 2828
Email
Kazemianm@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Kazemianm Mohammad
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Neonatal Health Research Center-Mofid Children Hospital - Shariati Ave.
City
Tehran
Province
Tehran
Postal code
1546815514
Phone
+98 21 2292 2827
Fax
+98 21 2292 2828
Email
Kazemianm@sbmu.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
Yes - There is a plan to make this available
Title and more details about the data/document
All individual data will be available after the publication of the article, after making the participants identifiable.
When the data will become available and for how long
Immediately after publication.
To whom data/document is available
It will be available for all researchers.
Under which criteria data/document could be used
To promote breastfeeding and the importance of the compounds and cells in it.
From where data/document is obtainable
Requests sent to the author's e-mail or other corresponders will be answered as soon as possible.
What processes are involved for a request to access data/document
Simple request sent to the corresponding author's email.
Comments
Since one of our goals is promoting breastfeeding, we will do our best to publish our findings.