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IRCT20210207050284N1 IRCT 2021-02-26 Shahre-kord University of Medical Sciences The effect of intravenous nutrition on weight gain pattern in premature infants Comparison of the effect of two different approaches to intravenous nutrition(TPN) on the pattern of weight gain in preterm infants weighing less than 1500 g admitted to the neonatal intensive care unit(NICU) of Hajar Hospital in Shahrekord 2021-04-04 anticipated 60 Complete https://irct.ir/trial/54232 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using Random Number Generator software, a random list of numbers from one to sixty is created. The first thirty numbers belong to the control group and the next thirty numbers belong to the case group. According to the order of hospitalization, infants are numbered from one to sixty and are placed in the control or intervention group based on the number. 3 Premature newborn. Intervention 1: Control group: Dextrose starts with infusion rate of 6 mg / kg / min on the first day of life and its dose is adjusted to provide random blood sugar between 60 and 120 mg / dL. Lipid ( Smoflipid emulsion20%, manufactured by Fresenius Kabi Austria Gmbh, contains soybean oil, medium chain fatty acid, omega 6 rich fish oil, olive oil and fat-soluble vitamins) at a rate of 3 g / kg and amino acid ( aminoven infant solution 10% production of Fresenius Kabi Austria Gmbh containing amino acid) starts at the rate of 5.3 g / kg. Enteral feeding starts at the first opportunity from 10 to 20 ml / kg per day depending on the infant's tolerance and when intral feeding reaches 100 ml / kg per day, intravenous feeding is stopped. Intervention 2: Intervention group: Dextrose begins at an infusion rate of 6 mg / kg / min on the first day of life and is adjusted to randomly adjust blood sugar levels between 60 and 120 mg / dL. Amino acids (10% neonatal amino solution produced by Fresenius Kabi Austria Gmbh containing amino acids) from 1 g / kg per day and lipids (20% Smoflipid emulsion, produced by Fresenius Kabi Austria Gmbh, containing soybean oil, medium chain fatty acid, rich fish oil From omega-6, olive oil and fat-soluble vitamins) start at 0.5 g / kg / day and increase by 1 g / kg both daily to a maximum of 5.3 g / kg / day for amino acids. And reach 3 grams per kilogram per day for lipids. Enteral feeding starts at the first opportunity from 10 to 20 ml / kg per day depending on the infant's tolerance and when intral feeding reaches 100 ml / kg per day, intravenous feeding is stopped. 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 Roya Choopani
Kashani Blvd., Headquarters of Shahrekord University of Medical Sciences
Shahrekord Iran (Islamic Republic of) 8815713471 +98 38 3333 0061 dr.choopani@yahoo.com Shahre-kord University of Medical Sciences scientific Roya Choopani
Kashani Blvd., Headquarters of Shahrekord University of Medical Sciences
Shahrekord Iran (Islamic Republic of) 8815713471 +98 38 3333 0061 dr.choopani@yahoo.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Premature neonate less than 1500 g 1 day 3 days Both Congenital anomaly Syndromic features Age over three days Severe illness Gestational age more than 37 weeks Weight more than 1500 grams P07.30 Preterm newborn, unspecified weeks of gestation Treatment - Drugs Treatment - Drugs Control group: Dextrose starts with infusion rate of 6 mg / kg / min on the first day of life and its dose is adjusted to provide random blood sugar between 60 and 120 mg / dL. Lipid ( Smoflipid emulsion20%, manufactured by Fresenius Kabi Austria Gmbh, contains soybean oil, medium chain fatty acid, omega 6 rich fish oil, olive oil and fat-soluble vitamins) at a rate of 3 g / kg and amino acid ( aminoven infant solution 10% production of Fresenius Kabi Austria Gmbh containing amino acid) starts at the rate of 5.3 g / kg. Enteral feeding starts at the first opportunity from 10 to 20 ml / kg per day depending on the infant's tolerance and when intral feeding reaches 100 ml / kg per day, intravenous feeding is stopped. Intervention group: Dextrose begins at an infusion rate of 6 mg / kg / min on the first day of life and is adjusted to randomly adjust blood sugar levels between 60 and 120 mg / dL. Amino acids (10% neonatal amino solution produced by Fresenius Kabi Austria Gmbh containing amino acids) from 1 g / kg per day and lipids (20% Smoflipid emulsion, produced by Fresenius Kabi Austria Gmbh, containing soybean oil, medium chain fatty acid, rich fish oil From omega-6, olive oil and fat-soluble vitamins) start at 0.5 g / kg / day and increase by 1 g / kg both daily to a maximum of 5.3 g / kg / day for amino acids. And reach 3 grams per kilogram per day for lipids. Enteral feeding starts at the first opportunity from 10 to 20 ml / kg per day depending on the infant's tolerance and when intral feeding reaches 100 ml / kg per day, intravenous feeding is stopped. Weight. Timepoint: Daily and 40th weeks of gestational age. Method of measurement: Scales. Height. Timepoint: Weekly and 40th weeks of gestational age. Method of measurement: Meters. Head circumference. Timepoint: Weekly and 40th weeks of gestational age. Method of measurement: Meters. Shahre-kord University of Medical Sciences Approved 2020-06-28 Ethics Committee of Shahrekord University of Medical Sciences Kashani Street,Vice Chancellor for Research, Shahrekord University of Medical Sciences Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)