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IRCT20171230038142N19 IRCT 2020-08-16 Esfahan University of Medical Sciences Effect of early administration of oropharyngeal colostrum on immune status and common morbidities of premature infants Effect of early administration of oropharyngeal colostrum on immune status and common morbidities of premature infants with gestational age Less or equal 30 weeks and birth body weight Less or equal 1500 gram 2020-03-05 anticipated 60 Complete https://irct.ir/trial/46405 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Blinding description: First, all mothers were asked to breastfeed as soon as possible and put it in a special sterile container. The nurse, who is familiar with the process, then takes the dishes from the mothers. The nurse, who is not present during the rest of the research, prepares colostrum syringes and distilled water, and each insulin syringe containing colostrum or distilled water is stamped with a large label that says the date of aggregation or distilled water and the baby's name. So that the content inside it is not clear and the neonatal nurse (clinical caregiver) does not understand and feeds each baby based on the syringe on which the baby's name is, and therefore is blinded in the process. Data analyzer is not aware of how to do the job. 2-3 Premature Infants. Intervention 1: Intervention group: For infants in this group, a syringe containing colostrum taken from the milk of infants' own mothers (0.2 ml) is oropharyngeally administered on the left and right sides of their mouth mucosa slowly for at least 2 minutes every 3 hours. The mentioned procedure continues for 72 hours from the beginning of the intervention. Before each appointment, the nurse will make sure that no secretion requiring suction is in the infants' mouth and nose. Intervention 2: Control group: For infants in this group, a syringe containing distilled water (0.2 ml) is oropharyngeally administered on the left and right sides of their mouth mucosa slowly for at least 2 minutes every 3 hours. The mentioned procedure continues for 72 hours from the beginning of the intervention. Before each appointment, the nurse will make sure that no secretion requiring suction is in the infants' mouth and nose. Yes - There is a plan to make this available What will be shared: The information is shared two years after the results are published. When: The information is shared two years after the results are published. To whom: Doctors and pediatricians Conditions: Comparison of the present method with another method or treatment Where to obtain: Send mohammadizadehm_z@yahoo.com an email How to obtain: Send mohammadizadehm_z@yahoo.com an email Comments:
public Azadeh Jafari
Al-Zahra Hospital, Sofah Boulevard.
Esfahan Iran (Islamic Republic of) 8174675731 +98 31 3668 0048 jafari@pharm.mui.ac.ir Esfahan University of Medical Sciences scientific Majid Mohammadi Zadeh
Al-Zahra Hospital, Sofah Boulevard.
Esfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 mohammadizadehm_z@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Infants less than or equal to 30 weeks old and weighing less than or equal to 1500 g Absence of major congenital malformations Apgar higher than 4 in the fifth minute of birth 1 day 1 day Both Unable to provide colostrum by the mother, to the extent required for study Diagnosis of early sepsis with positive blood culture Urinary Tract Infection Need to continue receiving aminoglycoside after the first 96 hours of birth Maternal HIV infection History of maternal chorio amnionitis O42.019 Preterm premature rupture of membranes, onset of labor within 24 hours of rupture, unspecified trimester Treatment - Drugs Placebo Intervention group: For infants in this group, a syringe containing colostrum taken from the milk of infants' own mothers (0.2 ml) is oropharyngeally administered on the left and right sides of their mouth mucosa slowly for at least 2 minutes every 3 hours. The mentioned procedure continues for 72 hours from the beginning of the intervention. Before each appointment, the nurse will make sure that no secretion requiring suction is in the infants' mouth and nose. Control group: For infants in this group, a syringe containing distilled water (0.2 ml) is oropharyngeally administered on the left and right sides of their mouth mucosa slowly for at least 2 minutes every 3 hours. The mentioned procedure continues for 72 hours from the beginning of the intervention. Before each appointment, the nurse will make sure that no secretion requiring suction is in the infants' mouth and nose. Urinary IgA Concentration. Timepoint: Before the intervention, eighth day of birth, 15th day of birth. Method of measurement: Measurement of IgA concentration in urine samples using Turbidometry method. The prevalence of necrotizing enterocolitis. Timepoint: During hospitalization. Method of measurement: Counting cases. The prevalence of mortality. Timepoint: During hospitalization. Method of measurement: death count. Duration of complete intestinal nutrition. Timepoint: During hospitalization. Method of measurement: Counting the days. Duration of hospitalization. Timepoint: Duration of hospitalization. Method of measurement: Counting the days. Esfahan University of Medical Sciences Approved 2020-02-01 Ethics Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jereyb Ave. Isfahan Isfehan Iran (Islamic Republic of)