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IRCT20210501051142N10 IRCT 2024-10-30 Arak University of Medical Sciences Effect of abdominal massage combined with mother kangaroo care on digestive consequences, weight gain and serum bilirubin level In premature infants Effect of abdominal massage combined with kangaroo mother care on digestive consequences, weight gain and serum bilirubin level In premature infants hospitalized in the neonatal intensive care unit 2024-11-02 anticipated 60 Complete https://irct.ir/trial/79597 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Infants are assigned to groups in the order of arrival and based on the randomization sequence that will be generated in advance that this sequence is unpredictable and has no specific pattern and its arrangement is completely random. To assign the samples to two groups, the block randomization method will be used with a block size of 4, so that by using the random number generation software in the block method, the randomization sequence will be produced according to the required sample size for the two groups. First, all the states where two letters A and B can be arranged together in a block of 2 are created then a block is randomly selected by placing it between the blocks and from the arrangement pattern in that block for infants allocation is used then this block will be placed in the main container and another block will be selected again. All this will be done with software called Sealed Envelope. With this method, concealment will also be observed. The concept of concealment is to unpredictably assign individuals to groups that the researcher will not be able to predict which group the next person will be in. N/A Premature infant. Intervention 1: Control group: This group will only receive routine ward care, including kangaroo care by the mother. Kangaroo care is taught to mothers by nurses. First, the infant is placed in a quiet and calm environment, naked and in a lying position on the stomach between the mother's breasts vertically, so that skin-to-skin contact is established between the mother and the baby. The infant's airway should be checked. The infant's hips should be bent in the "frog" position. The infant's arms should also be bent. The infant's stomach should not be contracted, so the baby has enough room for abdominal breathing. Care will be provided by the mother for 7 consecutive days, 3 times a day (according to ward routine) and each time for 1 hour. The feeding protocol and physical conditions of the environment will be the same for all premature babies. During the study, the newborns will be evaluated by the researcher in terms of weight gain, serum bilirubin level and digestive outcomes, including the residual volume of the stomach, the number of bowel movements, the number of vomiting and abdominal distension. Intervention 2: Intervention group: In this group, in addition to receiving Kangaroo care, the infant also receives abdominal massage. The massage will be performed by the researcher for 7 consecutive days using "Version" baby olive oil, made in Iran, 2 times a day (Once between 9 and 11 in the morning and the second time between 9 and 11 at night) and each time for 15 minutes. During the intervention period, the feeding protocol and physical conditions of the environment will be the same for all premature infant. Abdominal massage will be done slowly and rhythmically without tickling or putting pressure on the infant's skin, and if the infant is uncomfortable, it will be stopped immediately. The infant should be placed in a quiet and bright environment on the bed with the head at an angle of 30 to 45 degrees to the back. After washing the hands and heating them to reduce the friction, the researcher smeared the hands with "Version" olive oil and after testing the oil on the infant's forearm (in terms of rejecting a possible allergy to olive oil), She will perform the massage in the abdominal area in the "I Love U" method. In this way, the first touch is in the form of the letter I from top to bottom on the left side of the navel, the second touch is in the form of the letter L in reverse from right to left in the lower stomach, and the third touch is in the form of the letter U in reverse from right to left in the area around the navel. Yes - There is a plan to make this available What will be shared: Only the part of the data related to the original outcome will be able to be shared. When: since the winter of 2025 To whom: Researchers and students in this field Conditions: In order to increase weight and reduce serum bilirubin levels and improve digestive outcomes in premature infants. Where to obtain: Vice chancellor for education and research, Arak university of medical sciences How to obtain: These documents will be available on the website of Arak university of medical sciences. Comments:
public Mahbobeh Sajadi
University complex of Arak medical sciences, Basij square, Sardasht.
Arak Iran (Islamic Republic of) 3819693345 009886341735057 golmehrsherafati@gmail.com Arak University of Medical Sciences scientific Mahbobeh Sajadi
University complex of Arak medical sciences, Basij square, Sardasht
Arak Iran (Islamic Republic of) 3819693345 009886341735057 golmehrsherafati@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) No underlying congenital and infectious disease Birth weight less than 2,500 grams Born to non-addicted mothers with a gestational age of 28 to 36 weeks With a nasogastric tube Exclusive breastfeeding 1 day 21 days Both Infant parents' unwillingness to participate in the study Infants with severe respiratory distress during the study Deterioration of the infant condition P07.3 Preterm [premature] newborn [other] Other Other Control group: This group will only receive routine ward care, including kangaroo care by the mother. Kangaroo care is taught to mothers by nurses. First, the infant is placed in a quiet and calm environment, naked and in a lying position on the stomach between the mother's breasts vertically, so that skin-to-skin contact is established between the mother and the baby. The infant's airway should be checked. The infant's hips should be bent in the "frog" position. The infant's arms should also be bent. The infant's stomach should not be contracted, so the baby has enough room for abdominal breathing. Care will be provided by the mother for 7 consecutive days, 3 times a day (according to ward routine) and each time for 1 hour. The feeding protocol and physical conditions of the environment will be the same for all premature babies. During the study, the newborns will be evaluated by the researcher in terms of weight gain, serum bilirubin level and digestive outcomes, including the residual volume of the stomach, the number of bowel movements, the number of vomiting and abdominal distension. Intervention group: In this group, in addition to receiving Kangaroo care, the infant also receives abdominal massage. The massage will be performed by the researcher for 7 consecutive days using "Version" baby olive oil, made in Iran, 2 times a day (Once between 9 and 11 in the morning and the second time between 9 and 11 at night) and each time for 15 minutes. During the intervention period, the feeding protocol and physical conditions of the environment will be the same for all premature infant. Abdominal massage will be done slowly and rhythmically without tickling or putting pressure on the infant's skin, and if the infant is uncomfortable, it will be stopped immediately. The infant should be placed in a quiet and bright environment on the bed with the head at an angle of 30 to 45 degrees to the back. After washing the hands and heating them to reduce the friction, the researcher smeared the hands with "Version" olive oil and after testing the oil on the infant's forearm (in terms of rejecting a possible allergy to olive oil), She will perform the massage in the abdominal area in the "I Love U" method. In this way, the first touch is in the form of the letter I from top to bottom on the left side of the navel, the second touch is in the form of the letter L in reverse from right to left in the lower stomach, and the third touch is in the form of the letter U in reverse from right to left in the area around the navel. The rate of weight gain. Timepoint: Every 24 hours. Method of measurement: Weight gain in this study means the difference in the infant's weight from the start of the study to the last day of the intervention which will be measured once a day, according to the ward routine , by the researcher using the SECA scale, model 334-1321008, made in China. . The residual volume of the stomach. Timepoint: 8 times a day before each meal. Method of measurement: The amount of liquid remaining in the stomach before eating a new portion of milk is lavaged by the researcher with a syringe with a volume of 5 cc in order to check the amount of digestion of the previous meal. Defecation. Timepoint: 8 times a day before each meal. Method of measurement: In this study, defecation is the number of stools, which can be solid, semi-solid or liquid, reported by the infant's mother before each meal. Vomiting. Timepoint: 8 times a day before each meal. Method of measurement: Vomiting in this study means the number of times vomiting after drinking milk, which will be recorded by the infant's mother in the gastrointestinal outcomes checklist. Abdominal Distention. Timepoint: Every 24 hours. Method of measurement: A change of more than 1.5 cm in the size of the abdomen with or without a feeling of bloating, which was measured by the researcher using a meter and will be recorded in the digestive outcomes checklist. Bilirubin Level. Timepoint: Every 24 hours. Method of measurement: The infant's bilirubin is taken by capillary inside the capillary tube and sent to the hospital laboratory and measured by photometric method according to the routine of the newborn department and is continuously collected and recorded in the form. Arak University of Medical Sciences Approved 2024-09-08 Ethics committee of Arak university of medical sciences Arak university of medical sciences, Basij Sq., Sardasht region Arak Markazi Iran (Islamic Republic of)