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Protocol summary
63 infants received 0.2 ccs of their mother's colostrum through the oropharynx every 4 hours to 15 days from birth to the first 72 hours of birth. The other 63 infants were placebo and received 0.2 ccs of distilled water. And due to the apparent difference between distilled water and colostrum, the syringes are covered with white paper glue and the appearance of colostrum or distilled water is not seen.
63 infants received 0.2 ccs of their mother's colostrum through the oropharynx every 6 hours to 3 days from birth to the first 72 hours of birth. The other 63 infants were placebo and received 0.2 ccs of distilled water. And due to the apparent difference between distilled water and colostrum, the syringes are covered with white paper glue and the appearance of colostrum or distilled water is not seen.
63 infants received 0.2 ccs of their mother's colostrum through the oropharynx every 46 hours to 153 days from birth to the first 72 hours of birth. The other 63 infants were placebo and received 0.2 ccs of distilled water. And due to the apparent difference between distilled water and colostrum, the syringes are covered with white paper glue and the appearance of colostrum or distilled water is not seen.
63 تا از نوزادان 0.2 سی سی از کلستروم مادرشان را از طریق اوروفارنژیال هر 4 ساعت تا 15 روز با شروع از بدو تولد الی 72 ساعت اول تولد دریافت کردند. و 63 نوزاد دیگر از نوزادان گروه پلاسبو بوده و 0.2 سی سی اب مقطر دریافت کردند. و با توجه به تفاوت ظاهری اب مقطر دور تادور سرنگ ها با چسب سفید پوشیده شده است و ظاهر کلستروم یا اب مقطر دیده نمی شود.
63 تا از نوزادان 0.2 سی سی از کلستروم مادرشان را از طریق اوروفارنژیال هر 6 ساعت تا 3 روز با شروع از بدو تولد الی 72 ساعت اول تولد دریافت کردند. و 63 نوزاد دیگر از نوزادان گروه پلاسبو بوده و 0.2 سی سی اب مقطر دریافت کردند. و با توجه به تفاوت ظاهری اب مقطر دور تادور سرنگ ها با چسب سفید پوشیده شده است و ظاهر کلستروم یا اب مقطر دیده نمی شود.
63 تا از نوزادان 0.2 سی سی از کلستروم مادرشان را از طریق اوروفارنژیال هر 46 ساعت تا 153 روز با شروع از بدو تولد الی 72 ساعت اول تولد دریافت کردند. و 63 نوزاد دیگر از نوزادان گروه پلاسبو بوده و 0.2 سی سی اب مقطر دریافت کردند. و با توجه به تفاوت ظاهری اب مقطر دور تادور سرنگ ها با چسب سفید پوشیده شده است و ظاهر کلستروم یا اب مقطر دیده نمی شود.
General information
empty
In the method, the mother's colostrum was given oropharyngeal every six hours for three days, starting from birth to the first 72 hours of the baby's birth.
In the method, the mother's colostrum was given oropharyngeal every six hours for three days, starting from birth to the first 72 hours of the baby's birth.
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در روش اجرا کلستروم مادر به صورت اوروفارنژیال هر شش ساعت تا سه روز با شروع از بدو تولد تا 72 ساعت اول تولد نوزاد داده شد.
در روش اجرا کلستروم مادر به صورت اوروفارنژیال هر شش ساعت تا سه روز با شروع از بدو تولد تا 72 ساعت اول تولد نوزاد داده شد.
Sharing plan
no
undecided
noundecided
Protocol summary
Study aim
To assess the efficacy of oropharyngeal colostrum therapy on short outcome among preterm neonates
Design
This clinical trial study is designed as a double-blind, randomized placebo control group, and 126 preterm infants divided into 2 Groups are identified as groups A and B. The performer and the collector are not aware of the actual names of the group's
The cards shuffling method is used for refinement.
Settings and conduct
To hide the random allocation process, the order of interventions will be written on 126 cards and each card will be placed in an envelope.
Participants/Inclusion and exclusion criteria
Inclusion criteria for premature infants under 32 weeks or weighing less than 1500 grams are hospitalized in the intensive care unit of Fatemieh Hospital in Hamadan. The exclusion criteria are genetic and chromosomal disorders, HIV-positive mothers, and drug-addicted mothers—any case where there is a contraindication for milk feeding for the baby.
Intervention groups
63 infants received 0.2 ccs of their mother's colostrum through the oropharynx every 6 hours to 3 days from birth to the first 72 hours of birth. The other 63 infants were placebo and received 0.2 ccs of distilled water. And due to the apparent difference between distilled water and colostrum, the syringes are covered with white paper glue and the appearance of colostrum or distilled water is not seen.
Main outcome variables
Short-term prognosis of mortality and incidence of necrotizing enterocolitis and ventilator-associated pneumonia and the incidence of cerebral hemorrhage and the incidence of definite and clinical infections and the duration of hospitalization and the duration of complete oral nutrition in these infants and the rate of neonatal retinopathies Premature babies who need laser surgery are examined. The studied neonates will be monitored for a short period of up to one month.
General information
Reason for update
In the method, the mother's colostrum was given oropharyngeal every six hours for three days, starting from birth to the first 72 hours of the baby's birth.
Acronym
IRCT registration information
IRCT registration number:IRCT20210607051507N2
Registration date:2021-09-25, 1400/07/03
Registration timing:prospective
Last update:2024-02-23, 1402/12/04
Update count:1
Registration date
2021-09-25, 1400/07/03
Registrant information
Name
Ameneh Lamsehchi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6656 1315
Email address
lamsehchila@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-02, 1400/07/10
Expected recruitment end date
2022-03-01, 1400/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To assess the efficacy of oropharyngeal colostrum therapy on short outcome among preterm neonates
Public title
The effect of colostrum on the short outcome of premature infants
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Premature infants under 32 weeks of gestation Or below 1500 grams
Exclusion criteria:
Genetic and chromosomal abnormalities,
HIV-positive mother,
drug-addicted mother
Any case where there is a limitation on milk usage for the baby
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
Our sample size is 126, which is done by the cards or envelopes shuffling method. In this method, a number of cards selected by the researcher as group A and the same number of cards for group B are considered. This card will be returned to the other cards after leaving.
Blinding (investigator's opinion)
Double blinded
Blinding description
The list of random allocation of patients will be available only to the epidemiologist of the project. To hide the random allocation process, the order of interventions will be written on 126 cards and each card will be placed in an envelope (with a suitable thickness that it is not possible to read the type of intervention on the cover of the envelope). When the interviewer declares a baby eligible, the methodologist will provide the group with an intervention plan. The person evaluating the intended outcomes is a third party who is unaware of the random allocation process and the type of treatment performed. For data analysis, a statistician who is separate from the study process and is unaware of all the processes performed will be used.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Mahdieh St. Research Square Shahid Fahmideh St. University of Medical Sciences and Health Services Vice Chancellor for Research and Technology
City
Hamedan
Province
Tehran
Postal code
6517838687
Approval date
2021-09-04, 1400/06/13
Ethics committee reference number
IR.UMSHA.REC.1400.466
Health conditions studied
1
Description of health condition studied
The effect of colostrum on the short-term prognosis of preterm infants
ICD-10 code
P07.3
ICD-10 code description
Preterm [premature] newborn [other]
Primary outcomes
1
Description
Duration of preterm neonatal hospitalization
Timepoint
From the time of birth and hospitalization to the time of discharge
Method of measurement
Extract from the file
2
Description
How long it takes for a baby to be fully breastfed
Timepoint
From the onset of colostrum to breastfeeding 150 cc per kilogram of body weight
Method of measurement
Extract from the file
3
Description
Necrotizing enterocolitis in preterm infants
Timepoint
Since diagnosis based on clinical and radiological and laboratory symptoms
Method of measurement
Extraction from the file and clinical signs and radiological evidence recorded in the file
4
Description
Death of neonate
Timepoint
If there is no response to resuscitation and cardio-respiratory arrest
Method of measurement
Extract from file
5
Description
Confirmed neonatal sepsis
Timepoint
Since the diagnosis of neonates with clinical signs of sepsis with positive culture
Method of measurement
Extract blood and crp culture tests from hospital records and electronic systems
6
Description
clinical neonatal sepsis
Timepoint
Infant with clinical signs of sepsis diagnosed by a pediatrician
Method of measurement
Extract from file
7
Description
Brain hemorrhage
Timepoint
Brain sonography
Method of measurement
extract from file
8
Description
Bronchopulmonary dysplasia
Timepoint
Since the doctor's diagnosis and oxygen dependence
Method of measurement
Extract from file
9
Description
ROPs requiring laser surgery
Timepoint
Since the diagnosis of the eye to the doctor based on the need for laser surgery until 1 month old
Method of measurement
Extract from file
10
Description
Ventilator-associated pneumonia
Timepoint
Based on physician's diagnosis and radiographic findings
Method of measurement
Extract from file
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 63 infants received 0.2 cc of their mother's colostrum via the oropharynx every 6 hours to 3 days from birth to the first 72 hours of birth.
Category
Prevention
2
Description
Control group: The other 63 infants were placebo and received 0.2 cc of distilled water.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan Fatemieh Hospital
Full name of responsible person
Ameneh lamsehchi
Street address
Hamedan.Pasedaran street
City
Hamedan
Province
Tehran
Postal code
65179 97178
Phone
+98 81 3827 7459
Email
vc_research@umsha.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research and Technology of Hamadan University of Medical Sciences
Street address
Hamedan. Shahid Fahmideh Blvd. Hamedan University of Medical Sciences. Deputy of Research and Technology.
City
Hamedan
Province
Tehran
Postal code
6717838687
Phone
+98 81 3838 1938
Email
Webda@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Ameneh Lamsehchi
Position
Non-faculty specialist
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Hamadan Province, Hamedan, District 1, Pasdaran Ave,
City
Hamedan
Province
Tehran
Postal code
۶۵۱۷۷۸۹۹۷۱
Phone
+98 81 3827 7459
Email
lamsehchila@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
behnaz basiri
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Hamadan Province, Hamedan, District 1, Pasdaran Ave
City
Hamedan
Province
Tehran
Postal code
۶۵۱۷۷۸۹۹۷۱
Phone
+98 81 3827 7459
Email
vc_research@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ameneh Lamsehchi
Position
non-faculty specialist
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Hamadan Province, Hamedan, District 1, Pasdaran Ave,
City
Hamedan
Province
Tehran
Postal code
۶۵۱۷۷۸۹۹۷۱
Phone
+98 81 3827 8080
Email
lamsehchila@gmail.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
There is no more information
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available