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IRCT20171030037093N3 IRCT 2019-02-23 Shahre-kord University of Medical Sciences Effect of breast milk enrichment on early infants Investigation and comparison of the effect of early and late breast milk enrichment on preterm infants 2018-10-07 anticipated 90 Complete https://irct.ir/trial/37163 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention. 2-3 breast Milk enrichment in preterm infants. Intervention 1: First intervention group: On the first day of lactation Infants weighing less than 1000 grams recive 0.5-1 cc / kg breast milk every hour, Infants 1000 to 1500 grams recive 2-3 cc / kg breast milk every two hours and Infants weighing over 1600 grams recive More volume based on their tolerance every 2-3 hours through gavage. After the first day,lactation increases by 10-20 cc/ kg /day and up to 200-100 cc /kg / day.In this group, when the amount of milk received reached 30 cc kg / day, the interventions begin. in this way 4.4 g of the supplement of aptamil FMS ( NUTRICIA) is dissolved in each 100 cc of breast milk and it is given to the infant based on the amount of milk received by the infant per day through gavage .it contains 1 g of protein, 0g of fat, 2.7g of carbohydrate and a certain amount of some salts and vitamins.Breast milk enrichment continues for up to 4 weeks after birth. Intervention 2: Second intervention group: On the first day of lactation Infants weighing less than 1000 grams recive 0.5-1 cc / kg breast milk every hour, Infants 1000 to 1500 grams recive 2-3 cc / kg breast milk every two hours and Infants weighing over 1600 grams recive More volume based on their tolerance every 2-3 hours through gavage. After the first day,lactation increases by 10-20 cc/ kg /day and up to 200-100 cc /kg / day.In this group, when the amount of milk received reached 70 cc kg / day, the interventions begin. in this way 4.4 g of the supplement of aptamil FMS ( NUTRICIA) is dissolved in each 100 cc of breast milk and it is given to the infant based on the amount of milk received by the infant per day through gavage .it contains 1 g of protein, 0g of fat, 2.7g of carbohydrate and a certain amount of some salts and vitamins.Breast milk enrichment continues for up to 4 weeks after birth. Intervention 3: Third intervention group:On the first day of lactation Infants weighing less than 1000 grams recive 0.5-1 cc / kg breast milk every hour, Infants 1000 to 1500 grams recive 2-3 cc / kg breast milk every two hours and Infants weighing over 1600 grams recive More volume based on their tolerance every 2-3 hours through gavage. After the first day,lactation increases by 10-20 cc/ kg /day and up to 200-100 cc /kg / day.In this group, when the amount of milk received reached 100 cc kg / day, the interventions begin. in this way 4.4 g of the supplement of aptamil FMS ( NUTRICIA) is dissolved in each 100 cc of breast milk and it is given to the infant based on the amount of milk received by the infant per day through gavage .it contains 1 g of protein, 0g of fat, 2.7g of carbohydrate and a certain amount of some salts and vitamins.Breast milk enrichment continues for up to 4 weeks after birthount of some salts and vitamins. No - There is not a plan to make this available Justification or reason for not sharing IPD is data will be kept private.
public Majid Hamidi
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
Shahrekord Iran (Islamic Republic of) 8815713471 +98 38 3227 4004 majid.hamidi@yahoo.com Shahre-kord University of Medical Sciences scientific Majid Hamidi
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
Shahrekord Iran (Islamic Republic of) 8815713471 +98 38 3227 4004 majid.hamidi@yahoo.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Premature infants (28-32 weeks) weighing less than 2000 grams entery the study With the consent of the infant's parents 1 day 28 days Both any Congenital anomalies Formula feeding P07.3 Preterm [premature] newborn [other] Prevention Prevention Prevention First intervention group: On the first day of lactation Infants weighing less than 1000 grams recive 0.5-1 cc / kg breast milk every hour, Infants 1000 to 1500 grams recive 2-3 cc / kg breast milk every two hours and Infants weighing over 1600 grams recive More volume based on their tolerance every 2-3 hours through gavage. After the first day,lactation increases by 10-20 cc/ kg /day and up to 200-100 cc /kg / day.In this group, when the amount of milk received reached 30 cc kg / day, the interventions begin. in this way 4.4 g of the supplement of aptamil FMS ( NUTRICIA) is dissolved in each 100 cc of breast milk and it is given to the infant based on the amount of milk received by the infant per day through gavage .it contains 1 g of protein, 0g of fat, 2.7g of carbohydrate and a certain amount of some salts and vitamins.Breast milk enrichment continues for up to 4 weeks after birth Second intervention group: On the first day of lactation Infants weighing less than 1000 grams recive 0.5-1 cc / kg breast milk every hour, Infants 1000 to 1500 grams recive 2-3 cc / kg breast milk every two hours and Infants weighing over 1600 grams recive More volume based on their tolerance every 2-3 hours through gavage. After the first day,lactation increases by 10-20 cc/ kg /day and up to 200-100 cc /kg / day.In this group, when the amount of milk received reached 70 cc kg / day, the interventions begin. in this way 4.4 g of the supplement of aptamil FMS ( NUTRICIA) is dissolved in each 100 cc of breast milk and it is given to the infant based on the amount of milk received by the infant per day through gavage .it contains 1 g of protein, 0g of fat, 2.7g of carbohydrate and a certain amount of some salts and vitamins.Breast milk enrichment continues for up to 4 weeks after birth. Third intervention group:On the first day of lactation Infants weighing less than 1000 grams recive 0.5-1 cc / kg breast milk every hour, Infants 1000 to 1500 grams recive 2-3 cc / kg breast milk every two hours and Infants weighing over 1600 grams recive More volume based on their tolerance every 2-3 hours through gavage. After the first day,lactation increases by 10-20 cc/ kg /day and up to 200-100 cc /kg / day.In this group, when the amount of milk received reached 100 cc kg / day, the interventions begin. in this way 4.4 g of the supplement of aptamil FMS ( NUTRICIA) is dissolved in each 100 cc of breast milk and it is given to the infant based on the amount of milk received by the infant per day through gavage .it contains 1 g of protein, 0g of fat, 2.7g of carbohydrate and a certain amount of some salts and vitamins.Breast milk enrichment continues for up to 4 weeks after birthount of some salts and vitamins. Infant's weight. Timepoint: At the beginning of birth and 4 weeks after birth. Method of measurement: Scale. Infant's head circumference. Timepoint: At the beginning of birth and 4 weeks after birth. Method of measurement: Meter. Infant's height. Timepoint: At the beginning of birth and 4 weeks after birth. Method of measurement: Meter. Shahre-kord University of Medical Sciences Approved 2018-09-23 Ethics Committee of Shahrekord University of Medical Sciences Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)