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IRCT20230312057698N1 IRCT 2023-03-29 Babol University of Medical Sciences Investigating the effect of Oropharyngeal colostrum in the prevention of late-onset sepsis in preterm infants admitted to neonatal intensive care unit by extraoral massage method OPT,OAC,C-OIT Investigating the effect of Oropharyngeal colostrum in the prevention of late-onset sepsis in preterm infants admitted to neonatal intensive care unit by extraoral massage method 2023-04-09 anticipated 70 Complete https://irct.ir/trial/69281 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, a parallel randomized controlled trial (parallel randomized controlled trial) considering that not all babies are included in the study at the same time and researchers cannot predict in advance which group each baby who is included in the study will belong to, for allocation Block randomization will be used to assign each baby to one of the two groups. In order to hide the random allocation, the codes created by the software will be placed in opaque envelopes so that it is not clear which group the next person will be assigned to. In order to hide the random allocation, the codes created by the software will be placed in opaque envelopes so that it is not clear which group the next person will be assigned to. In this study, the participating infants will be assigned to one of two control and intervention groups according to the random block division protocol (produced by Random Allocation Software) with a ratio of 1:1 and in blocks of 6, so that the researcher It cannot predict which intervention group the next person is placed in. The codes will be placed in the opaque envelopes, and with the entry of each new person, the envelope will be opened and the person's belonging to the relevant group will be determined, Blinding description: Regarding the blinding method, this design is double-blind. In this study, the researcher and the nurses of the executive team are informed about the goals of the project and the groups, but the baby's parents, the evaluator (neonatal doctor) and the analyst (the person who performs the statistical analysis) are not aware of the groups. N/A late-onset sepsis. Intervention 1: Intervention group: In the intervention group, 0.4 ml (4 units) of mother's colostrum was drawn into a 1 ml syringe (insulin syringe) and 0.2 ml (2 units) on each side of the mouth on the gum surface (buccal cavities). ), cheek, palate, and tongue surface every 3 hours for 7 days, and each cheek is massaged from the outside of the mouth for at least 10 seconds using the index finger. Intervention 2: Control group: In the control group, routine oral care of the neonatal intensive care unit will be performed. In this group, mother's colostrum in the amount of 0.2 ml of colostrum is poured into the baby's mouth as a mouthwash every 3 hours for 7 days and cleaned with a swab. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Neda behroj
Mazandaran, Babol, Ganj Afrooz Road, Babol University of Medical Sciences - Faculty of Nursing and Midwifery - Department of Nursing
Babol Iran (Islamic Republic of) 4841849533 +98 11 3474 1827 nedabehroj63@gmail.com Babol University of Medical Sciences scientific Parvin Aziznejad Roshan
Mazandaran-Babol - Ganj Afroz Road - Babol University of Medical Sciences - Faculty of Nursing and Midwifery - Department of Nursing
Babol Iran (Islamic Republic of) ۴۷۱۷۶-۴۷۷۴۵ +98 11 3219 0181 aziznejadroshan@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) Premature infants with a gestational age between 28 and 32 Premature infants without congenital abnormalities (digestive disorders) or genetic syndromes Premature infants without mechanical ventilation infant being NPO Not having early sepsis or not having early sepsis risk factors The mother's absence of active viral infections during pregnancy and childbirth 1 day 2 days Both The infant's condition is not stable during the intervention more than twice (loss of saturation, bradycardia,...) Parents withdraw from continuing the research project or infants die before 7 days infants need urgent surgery P36 Bacterial sepsis of newborn Prevention Prevention Intervention group: In the intervention group, 0.4 ml (4 units) of mother's colostrum was drawn into a 1 ml syringe (insulin syringe) and 0.2 ml (2 units) on each side of the mouth on the gum surface (buccal cavities). ), cheek, palate, and tongue surface every 3 hours for 7 days, and each cheek is massaged from the outside of the mouth for at least 10 seconds using the index finger. Control group: In the control group, routine oral care of the neonatal intensive care unit will be performed. In this group, mother's colostrum in the amount of 0.2 ml of colostrum is poured into the baby's mouth as a mouthwash every 3 hours for 7 days and cleaned with a swab. Late-onset sepsis. Timepoint: 72 hours after birth. Method of measurement: In order to distinguish clinical sepsis from other differential diagnoses in the intensive care unit of newborns, two factors CRP (C-reactive protein) and PCT (procalcitonin) are checked for suspected babies.Clinical sepsis by examining 6 criteria that include general appearance symptoms (temperature instability, paleness, skin reticulation or motilization, jaundice, bruising, petechiae) and nervous system symptoms (lethargy or irritability, hypertonia or hypotonia, loud crying) loud, trembling, restlessness) and symptoms of the cardiovascular system (tachycardia or bradycardia, hypotension, cyanosis) and symptoms of the respiratory system (apnea or tachypnea, decrease in blood oxygen saturation, hearing the sound of a baby moaning or grunting, drawn in chest muscles or retraction) and digestive system symptoms (abdominal distention, vomiting, food intolerance, diarrhea) and urinary reproductive system symptoms (decrease in urinary output or oliguria)] are determined. Babol University of Medical Sciences Approved 2023-03-11 Ethics Committee of Babol University of Medical Sciences Mazandaran, Babol, Ganj Afrooz Road, Babol University of Medical Sciences - Faculty of Nursing and Midwifery - Department of Nursing Babol Mazandaran Iran (Islamic Republic of)