Comparative study of the effect of hydrolyzed formula and standard formula in the first two weeks of life in preterm infants less than 34 weeks on improving nutritional tolerance and the prevalence of necrotizing enterocolitis.
The effect of hydrolyzed formula and standard formula in premature infants on improving nutritional tolerance and prevalence of necrotizing enterocolitis.
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 104 patients. Excel software rand function was used for randomization.
Settings and conduct
Clinical trial on 104 premature infants during 1398 and 1399 in the NICU of Akbarabadi Hospital and Hazrat Ali Asghar Hospital. Each patient was randomly assigned to two treatments 1 and 2 (52 people in each group), respectively. . After two weeks, the improvement of nutritional tolerance and the prevalence of necrotizing enterocolitis in both groups were evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Premature infants/ less than 34 weeks deprived of breast milk / without congenital underlying disorders
Exclusion criteria: Infants with dissatisfaction of parents or addicted parents, asphyxia Apgar fifth minute less than seven, IUG-R, and congenital anomalies.
Intervention groups
The intervention group is infants less than 34 weeks of age who do not have access to breast milk for any reason. They are fed with hydrolyzed formula.
The control group includes infants less than 34 weeks of age who are not available breast milk for any reason. They are fed according to the standard formula.
Main outcome variables
Nutritional tolerance in infants, risk of necrotizing enterocolitis, length of hospital stay, prevalence of sepsis in preterm infants.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160120026115N7
Registration date:2022-01-17, 1400/10/27
Registration timing:retrospective
Last update:2022-01-17, 1400/10/27
Update count:0
Registration date
2022-01-17, 1400/10/27
Registrant information
Name
Mandana Kashaki
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5563 2277
Email address
kashakimd@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2022-01-05, 1400/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of hydrolyzed formula and standard formula in the first two weeks of life in preterm infants less than 34 weeks on improving nutritional tolerance and the prevalence of necrotizing enterocolitis.
Public title
Effect of hydrolyzed formula and standard formula in the first two weeks of life in preterm infants
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Infants less than 34 weeks gestationally deprived of breast milk
Infants without underlying congenital disorders
Exclusion criteria:
Infants were excluded from the study with parental dissatisfaction.
Infants from addicted parents were excluded from the study.
Infants with asphyxia were excluded from the study.
Infants with a fifth minute Apgar score of less than seven were excluded from the study.
Infants with IUG-R were excluded from the study.
Infants with congenital anomalies were excluded from the study.
Age
From 1 day old to 14 days old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization in this study is done by simple randomization method using Rand function of Excel software. First, 104 random numbers are created in a column using the Rand function. Then in the second column, from the numbers one to 104, new columns are inserted in front of each random code. Finally, in the third column, 52 lines are filled with code A and 52 lines with code B are filled. After arranging the size of the first column numbers using the software, by maintaining their connection to the second and third column numbers, a random sequence in the third column is ready. The numbers in the second column, each assigned to one of two groups based on the corresponding row in the third column, can be used as the row code used in hiding.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The powdered milk of both groups are packed in containers of the same shape and after preparing a random list by a person outside the executing group and receiving the interventions, they are labeled based on the codes obtained in randomization. The sequence of random codes will be hidden from this person (or the principal investigator's representative for blindness) until the end of the study, and will only be opened at the request of the principal investigator if necessary to avoid endangering the lives of the volunteers.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat highway
City
Tehran
Province
Tehran
Postal code
1494868871
Approval date
2020-07-22, 1399/05/01
Ethics committee reference number
IR.IUMS.FMD.REC.1399.478
Health conditions studied
1
Description of health condition studied
Necrotizing enterocolitis
ICD-10 code
P77.9
ICD-10 code description
Necrotizing enterocolitis in newborn, unspecified
Primary outcomes
1
Description
Improvement in nutritional tolerance
Timepoint
From the start of feeding the baby to the time of discharge from the hospital
Method of measurement
Clinical examination corresponding to the disease
2
Description
Reducing the incidence of necrotizing enterocolitis in premature infants
Timepoint
From the start of feeding the baby to the time of discharge from the hospital
Method of measurement
Clinical and laboratory examination corresponding to the disease
Secondary outcomes
1
Description
Duration of hospital stay
Timepoint
From the start of feeding the baby to the time of discharge from the hospital
Method of measurement
Number of days of hospitalization based on the contents of the file
2
Description
sepsis
Timepoint
From the start of feeding the baby to the time of discharge from the hospital
Method of measurement
Positive blood culture
Intervention groups
1
Description
In the intervention group, the hydrolyzed formula is used for feeding in all meals. The hydrolyzed formula in all members of the intervention group was from the same brand (Aptamil / Nutricia).How to prepare milk powder according to the manufacturer's instructions was one measure per 30 cc of water.
Category
Prevention
2
Description
Control group: The regular formula is used for feeding in all meals. The regular formula in all members of the intervention group was from the same brand (Aptamil / Nutricia). How to prepare milk powder according to the manufacturer's instructions was one measure per 30 cc of water.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar Abadi hospital
Full name of responsible person
Mandana Kashaki
Street address
Akbar Abadi Hospital, Molavi Ave
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Email
kashakimd@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila Irani
Street address
Iran University of Medical Sciences, Hemmat highway
City
Tehran
Province
Tehran
Postal code
1494868871
Phone
+98 21 4474 0360
Email
kashakimd@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mandana Kashaki
Position
Associated professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shahid Akbar Abadi Hospital; molavi Ferdows Station; tehran
City
tehran
Province
Tehran
Postal code
1494868871
Phone
+98 21 5563 2277
Fax
Email
kashakimd@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mandana Kashaki
Position
Associated Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
hemmat high way, Tehran
City
Tehran
Province
Tehran
Postal code
1494868871
Phone
+98 21 5563 2277
Fax
+98 21 5563 2277
Email
kashakimd@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mandana Kashaki
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
hemmat high way-Tehran-Iran
City
Tehran
Province
Tehran
Postal code
۱۱۶۸۷۴۳۵۱۴
Phone
+98 21 5563 2277
Fax
+98 21 5563 2277
Email
kashakimd@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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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 data is potentially shareable after unidentifiable individuals
When the data will become available and for how long
The access period starts one year after the results are published.
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
The data are allowed for further studies on this research topic.
From where data/document is obtainable
Leila Irani/ Iran University of Medical Sciences/ Iran University of Medical Sciences, Hemmat highway/ or Email address: kashakimd@gmail.com
What processes are involved for a request to access data/document