Protocol summary
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Study aim
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To assess the efficacy of oropharyngeal colostrum therapy on short outcome among preterm neonates
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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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
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Reason for update
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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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Acronym
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IRCT registration information
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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
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Registration date
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2021-09-25, 1400/07/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-10-02, 1400/07/10
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Expected recruitment end date
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2022-03-01, 1400/12/10
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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To assess the efficacy of oropharyngeal colostrum therapy on short outcome among preterm neonates
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Public title
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The effect of colostrum on the short outcome of premature infants
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
126
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-09-04, 1400/06/13
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Ethics committee reference number
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IR.UMSHA.REC.1400.466
Health conditions studied
1
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Description of health condition studied
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The effect of colostrum on the short-term prognosis of preterm infants
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ICD-10 code
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P07.3
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ICD-10 code description
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Preterm [premature] newborn [other]
Primary outcomes
1
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Description
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Duration of preterm neonatal hospitalization
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Timepoint
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From the time of birth and hospitalization to the time of discharge
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Method of measurement
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Extract from the file
2
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Description
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How long it takes for a baby to be fully breastfed
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Timepoint
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From the onset of colostrum to breastfeeding 150 cc per kilogram of body weight
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Method of measurement
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Extract from the file
3
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Description
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Necrotizing enterocolitis in preterm infants
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Timepoint
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Since diagnosis based on clinical and radiological and laboratory symptoms
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Method of measurement
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Extraction from the file and clinical signs and radiological evidence recorded in the file
4
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Description
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Death of neonate
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Timepoint
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If there is no response to resuscitation and cardio-respiratory arrest
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Method of measurement
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Extract from file
5
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Description
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Confirmed neonatal sepsis
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Timepoint
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Since the diagnosis of neonates with clinical signs of sepsis with positive culture
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Method of measurement
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Extract blood and crp culture tests from hospital records and electronic systems
6
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Description
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clinical neonatal sepsis
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Timepoint
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Infant with clinical signs of sepsis diagnosed by a pediatrician
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Method of measurement
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Extract from file
7
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Description
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Brain hemorrhage
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Timepoint
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Brain sonography
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Method of measurement
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extract from file
8
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Description
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Bronchopulmonary dysplasia
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Timepoint
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Since the doctor's diagnosis and oxygen dependence
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Method of measurement
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Extract from file
9
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Description
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ROPs requiring laser surgery
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Timepoint
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Since the diagnosis of the eye to the doctor based on the need for laser surgery until 1 month old
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Method of measurement
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Extract from file
10
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Description
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Ventilator-associated pneumonia
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Timepoint
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Based on physician's diagnosis and radiographic findings
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Method of measurement
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Extract from file
Intervention groups
1
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Description
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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.
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Category
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Prevention
2
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Description
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Control group: The other 63 infants were placebo and received 0.2 cc of distilled water.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Hamedan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no more information
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable