determination and comparison of the effect of early and late breast milk enrichment on preterm infants
Design
Clinical trial with parallel groups
Settings and conduct
90 Preterm infants admitted to NICU at Hajar Hospital in Shahrekord randomly divided into 3 groups of 30.Then breast milk enrichment for infants is started based on the intervention group at a certain time and continues to 4 weeks. Height, weight and head circumference of infants are measured at the birth time and 4 weeks after birth.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Infants with Gestational age of 28 to 32 weeks with birth body weight less than 2000 g
Exclusion criteria:The presence of Any congenital anomalies; formula feeding
Intervention groups
90 Preterm infants entered the study.On the first day of lactation Infants weighing less than 1000 grams recive 0.5-1 cc / kg breast milk every hour, Infants 1000 to 1500 grams recive 2-3 cc / kg breast milk every two hours and Infants weighing over 1600 grams recive More volume based on their tolerance every 2-3 hours through gavage. After the first day,lactation increases by 10-20 cc/ kg /day and up to 200-100 cc /kg / day. In the first group, when the amount of milk received reached 30 cc kg / day, the second group when reached 70 cc kg / day and the third group when reached 100 cc / kg /day, the interventions begin. in this way 4.4 g of the supplement of aptamil FMS ( NUTRICIA) is dissolved in each 100 cc of breast milk and it is given to the infant based on the amount of milk received by the infant per day through gavage .it contains 1 g of protein, 0g of fat, 2.7g of carbohydrate and a certain amount of some salts and vitamins.Breast milk enrichment continues for up to 4 weeks after birth.
Main outcome variables
height; weight; head circumference
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171030037093N3
Registration date:2019-02-23, 1397/12/04
Registration timing:retrospective
Last update:2019-02-23, 1397/12/04
Update count:0
Registration date
2019-02-23, 1397/12/04
Registrant information
Name
Sadra Ansaripour
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 3487
Email address
st_ansari.s@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-07, 1397/07/15
Expected recruitment end date
2019-03-06, 1397/12/15
Actual recruitment start date
2017-11-11, 1396/08/20
Actual recruitment end date
2018-11-01, 1397/08/10
Trial completion date
2018-11-01, 1397/08/10
Scientific title
Investigation and comparison of the effect of early and late breast milk enrichment on preterm infants
Public title
Effect of breast milk enrichment on early infants
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Premature infants (28-32 weeks) weighing less than 2000 grams
entery the study With the consent of the infant's parents
Exclusion criteria:
any Congenital anomalies
Formula feeding
Age
From 1 day old to 28 days old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Shahrekord University of Medical Sciences
Street address
Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713492
Approval date
2018-09-23, 1397/07/01
Ethics committee reference number
IR.SKUMS.REC.1397.145
Health conditions studied
1
Description of health condition studied
breast Milk enrichment in preterm infants
ICD-10 code
P07.3
ICD-10 code description
Preterm [premature] newborn [other]
Primary outcomes
1
Description
infant's weight
Timepoint
At the beginning of birth and 4 weeks after birth
Method of measurement
Scale
2
Description
infant's head circumference
Timepoint
At the beginning of birth and 4 weeks after birth
Method of measurement
Meter
3
Description
infant's height
Timepoint
At the beginning of birth and 4 weeks after birth
Method of measurement
Meter
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: On the first day of lactation Infants weighing less than 1000 grams recive 0.5-1 cc / kg breast milk every hour, Infants 1000 to 1500 grams recive 2-3 cc / kg breast milk every two hours and Infants weighing over 1600 grams recive More volume based on their tolerance every 2-3 hours through gavage. After the first day,lactation increases by 10-20 cc/ kg /day and up to 200-100 cc /kg / day.In this group, when the amount of milk received reached 30 cc kg / day, the interventions begin. in this way 4.4 g of the supplement of aptamil FMS ( NUTRICIA) is dissolved in each 100 cc of breast milk and it is given to the infant based on the amount of milk received by the infant per day through gavage .it contains 1 g of protein, 0g of fat, 2.7g of carbohydrate and a certain amount of some salts and vitamins.Breast milk enrichment continues for up to 4 weeks after birth
Category
Prevention
2
Description
Second intervention group: On the first day of lactation Infants weighing less than 1000 grams recive 0.5-1 cc / kg breast milk every hour, Infants 1000 to 1500 grams recive 2-3 cc / kg breast milk every two hours and Infants weighing over 1600 grams recive More volume based on their tolerance every 2-3 hours through gavage. After the first day,lactation increases by 10-20 cc/ kg /day and up to 200-100 cc /kg / day.In this group, when the amount of milk received reached 70 cc kg / day, the interventions begin. in this way 4.4 g of the supplement of aptamil FMS ( NUTRICIA) is dissolved in each 100 cc of breast milk and it is given to the infant based on the amount of milk received by the infant per day through gavage .it contains 1 g of protein, 0g of fat, 2.7g of carbohydrate and a certain amount of some salts and vitamins.Breast milk enrichment continues for up to 4 weeks after birth.
Category
Prevention
3
Description
Third intervention group:On the first day of lactation Infants weighing less than 1000 grams recive 0.5-1 cc / kg breast milk every hour, Infants 1000 to 1500 grams recive 2-3 cc / kg breast milk every two hours and Infants weighing over 1600 grams recive More volume based on their tolerance every 2-3 hours through gavage. After the first day,lactation increases by 10-20 cc/ kg /day and up to 200-100 cc /kg / day.In this group, when the amount of milk received reached 100 cc kg / day, the interventions begin. in this way 4.4 g of the supplement of aptamil FMS ( NUTRICIA) is dissolved in each 100 cc of breast milk and it is given to the infant based on the amount of milk received by the infant per day through gavage .it contains 1 g of protein, 0g of fat, 2.7g of carbohydrate and a certain amount of some salts and vitamins.Breast milk enrichment continues for up to 4 weeks after birthount of some salts and vitamins.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar Hospital
Full name of responsible person
Hadi Lachinani
Street address
Hajar Hospital,Nursing Street ,Kashan Blvd,Shahrekord City,Chahar Mahal and Bakhtiari
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۶۷۵۴۶۳۳
Phone
+98 38 3222 0016
Email
Hajar-Hospital@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. seyed Kamal Solati
Street address
Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 2414
Email
kamal_solati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Majid Hamidi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3227 4004
Email
majid.hamidi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Majid Hamidi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3227 4004
Email
majid.hamidi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Majid Hamidi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3227 4004
Email
majid.hamidi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
data will be kept private.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information about the main outcome can be shared.
When the data will become available and for how long
Start the access period 4 months after printing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Use data to complete fundamental studies
From where data/document is obtainable
Hajar Hospital in Shahrekord, hadilachinanimd@gmail.com
What processes are involved for a request to access data/document
after delibration of researcher request and presentation of adequate documents,it will be able to exhibite.