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IRCT20210227050516N1 IRCT 2021-04-11 Tehran University of Medical Sciences The effect of breast milk odor on respiratory distress and oxygen saturation of preterm infants in intensive care unit The effect of breast milk odor on respiratory distress and oxygen saturation of preterm infants in intensive care unit 2021-03-06 anticipated 96 Complete https://irct.ir/trial/54676 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, first, individuals are entered into the study in an accessible manner based on inclusion and exclusion criteria, and then, using permutation blocks, they are divided into two groups: breast milk odor and formula milk odor (32 people in each group) and will be allocated. In this method, if we consider the odor group of breast milk as A, the odor group of formula as B, the 6 possible states will be in the four blocks of AABB-BBAA-ABAB-BABA-BAAB-ABBA, which is assigned a number to each block. Will be found and each time a lottery will be selected and the babies will enter the study in order, Blinding description: The study will be blinded in two ways. Parents of infants and ward nurses will be blinded as to which group (control or intervention) they are in (unaware of the assignment of study groups) and the statistician who should analyze the data will be blinded to the type of intervention.In the analysis form, the intervention and control groups are identified by a specific code that only the researcher is aware of, and the statistical consultant does not know the definition of the codes. N/A respiratory distress. Intervention 1: Intervention group1: Infants who are exposed to the smell of breast milk. 3 cc of milk is taken daily from mothers to perform research; Sampling is done in the morning before breakfast to reduce the effect of odor on the milk in the mother's diet; Because the smell of food is secreted in milk 2-4 hours after consumption. Milk is stored in special plastic containers in the refrigerator. It is worth mentioning that breast milk will be used twice a day; ; Once at 8 o'clock in the morning and the next time at 12 noon, considering that the milk will be taken from the mothers only in the morning, the milk should be kept in the refrigerator for the evening shift. Prior to the intervention, the breast milk will be heated to 37 ° C by a water heater (Ben Marie). Intervention 2: Intervention group2:To prepare formula milk as a placebo (placebo group), use dry milk for premature babies with the Bebelac brand in the section, which was prepared just before use. Prior to the intervention, the formula milk (to body temperature) will be heated to 37 ° C by a water heater (Ben Marie). Intervention 3: Control group: Does not receive any intervention. 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 more information
public Akram Sadat Hosseini
Tohid Square - Nosrat Sharghi St. - Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6693 7120 tehrantarasht@gmail.com Tehran University of Medical Sciences scientific Akram Sadat Hosseini
Tohid Square - Nosrat Sharghi St. - Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) 1419733171 00 (21) 66937120 tehrantarasht@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) The baby should be in the first 24 hours after birth Intrauterine age less than 37 weeks at birth Stored inside the incubator The baby's body temperature is in the range of 2.36 / 2-37 degrees Celsius RDS score Between 5 and 8 Apgar score is five minutes, seven and more Mother of cigarettes, alcohol or unused drugs No severe congenital anomalies and congenital infections The baby is not under Early Cpap 1 day 5 days Both Having a secondary infection Seizures Consecutive apnea Grade 3 and 4 intraventricular hemorrhage based on third day ultrasound Registration or death of the infant before the intervention J80 Acute respiratory distress syndrome Treatment - Other Placebo Lifestyle Intervention group1: Infants who are exposed to the smell of breast milk. 3 cc of milk is taken daily from mothers to perform research; Sampling is done in the morning before breakfast to reduce the effect of odor on the milk in the mother's diet; Because the smell of food is secreted in milk 2-4 hours after consumption. Milk is stored in special plastic containers in the refrigerator. It is worth mentioning that breast milk will be used twice a day; ; Once at 8 o'clock in the morning and the next time at 12 noon, considering that the milk will be taken from the mothers only in the morning, the milk should be kept in the refrigerator for the evening shift. Prior to the intervention, the breast milk will be heated to 37 ° C by a water heater (Ben Marie). Intervention group2:To prepare formula milk as a placebo (placebo group), use dry milk for premature babies with the Bebelac brand in the section, which was prepared just before use. Prior to the intervention, the formula milk (to body temperature) will be heated to 37 ° C by a water heater (Ben Marie). Control group: Does not receive any intervention Respiratory distress. Timepoint: Before the intervention - four hours after the intervention and 8 hours after the intervention. Method of measurement: Respiratory Distress Assessment Questionnaire (Downs Score). Blood oxygen saturation. Timepoint: Before intervention - 4 hours after intervention and 8 hours after intervention. Method of measurement: Pulse oximetry device. medical University Tehran Approved 2021-02-20 Ethics Committee of Tehran University of Medical Sciences Jomhory St. 60. No. 16 Qom Tehran Iran (Islamic Republic of)