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IRCT20160120026115N6 IRCT 2018-02-17 Vice chancellor for research of Iran University of Medical Sciences Evaluation of the effect of high dose interalipid administration versus its gradual increase in neonates weighing less than 1500 Evaluation of the effect of high dose interalipid administration versus its gradual increase in neonates weighing less than 1500 2016-03-20 anticipated 104 Complete https://irct.ir/trial/21734 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization type is simple randomization and randomization unit were individual. Individuals were randomly divided into two groups of control and study. N/A advising of high doses interalipid. Intervention 1: Control group: this group started with an injectable lipid emulsion from 1 gr / kg per 24 hours and increase 1 gram daily to 3 grams per kilogram per 24 hours . We monitor neonate with milk feeding until 100 cc / kg Or up to one month old (each one will arrive sooner). Intervention 2: Intervention group: In the other group, initially, an interlipid dose of 3 grams per kilogram for 24 hours recommended. Yes - There is a plan to make this available What will be shared: The total potential data can be shared after unidentifiable people. When: The start of the access period is 6 months after the results are printed. To whom: Data will only be available to researchers in academia. Conditions: Other conditions for the use of data or documentation are those who have been approved by scholars working in academic and scientific institutions. Where to obtain: Doctor Mandana Kashaki tel:09123580373 kashakimd@gmail.com Doctor Babak Jafarvand tel:09122833963 babakjafarvand@gmail.com How to obtain: The start of the access period is 6 months after the results are printed. Data will only be available to researchers in academia. Other conditions for the use of data or documentation are those who have been approved by scholars working in academic and scientific institutions. Comments:
public Mandana Kashaki
hemmat high way, Tehran
Tehran Iran (Islamic Republic of) 1494868871 +98 21 5563 2277 kashakimd@gmail.com Iran University of Medical Sciences scientific Mandana Kashaki
Shahid Akbar Abadi Hospital; molavi Ferdows Station; tehran
tehran Iran (Islamic Republic of) 1494868871 +98 21 5563 2277 kashakimd@gmail.com Akbar Abadi Hospital Iran (Islamic Republic of) All children born in Akbar Abadi Hospital with a birth weight of less than 1500 grams. Had no perinatal asphyxia (Apgar 5 minutes below 6). Parents had a written consent for entry into the study. Had no major anomalies. 1 day 28 days Both If there is any evidence of sepsis before randomization If there is any evidence of metabolic acidosis before randomization hypoxia less than 90% before randomization Treatment - Drugs Treatment - Drugs Control group: this group started with an injectable lipid emulsion from 1 gr / kg per 24 hours and increase 1 gram daily to 3 grams per kilogram per 24 hours . We monitor neonate with milk feeding until 100 cc / kg Or up to one month old (each one will arrive sooner). Intervention group: In the other group, initially, an interlipid dose of 3 grams per kilogram for 24 hours recommended. Triglyceride. Timepoint: Before the intervention, then twice a week. Method of measurement: laboratory kit. Arterial blood gas analysis and blood bicarbonate. Timepoint: Before the intervention, then twice a week. Method of measurement: laboratory kit. Blood glucose. Timepoint: Before the intervention and then daily. Method of measurement: laboratory kit. Neonate weight. Timepoint: Before the intervention and then daily. Method of measurement: Scales. CRP. Timepoint: Before the intervention, then twice a week. Method of measurement: laboratory kit. Blood culture. Timepoint: Before intervention and then if symptoms of sepsis occur. Method of measurement: Observation of microbial growth in culture media. Vice chancellor for research of Iran University of Medical Sciences Approved 2017-01-28 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Road, Tehran Tehran Tehran Iran (Islamic Republic of)