]>
IRCT201310164113N4 IRCT 2014-02-07 Pediatric Health Research Center of Tabriz University of Medical Sceinces Evaluation of Enteral Erythropoietin in prevention of Necrotizing Entrocolits in Very Low Birth Weight infants Evaluation of Enteral Recombinant Erythropoietin(R-EPO) in prevention of Necrotizing Entrocolits in Very Low Birth Weight infants 2014-01-21 anticipated 105 Complete https://irct.ir/trial/4337 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention. N/A Necrotizing Enterocolitis of fetus and neonate. Intervention 1: In Control group of the patients breast milk will be started and increase according the routine guideline of the unit without any solutions. Intervention 2: The first group of the (case) patients will receive the synthetic Amniotic fluid solution with Recombinant Erythropoietin(r-EPO) . The hospital pharmacist will make the solution using sterile technique and The solution contained contains ; 115 meq/l sodium chloride, 17 meq/L sodium acetate, and 4 meq/l potassium chloride,4400 mU/ml Epoetin alfa (Epogen, Amgen). Human serum albumin (5%) will be added to the infusion bag prior to the addition of the rEPO (final concentration of albumin=0.05%). The fluid contain a 10-fold higher concentration of Epo than natural amniotic fluid . Aliquots (10 ml) will be frozen until use. Solution in the syringe will be pushed through the orogastric tube prior to insertion into the patient in order to reduce binding of rEpo to the plastic tubing. Upon enrollment of a subject a full day's dose will thawed. The full day's dose (5 Ml/Kg/D will then be divided into 3 equal amounts, to be administered by the bedside nurse every 8 hours. Each aliquot will allow warming to room temperature before it will administer. They will also receive feeding with breast milk after giving the fluid. The nurse of the patient and the person who are responsible for data collection will be blind to the group of the patients and the solutions. Intervention 3: The second group of the(case) patients will receive the synthetic Amniotic fluid solution without Recombinant Erythropoietin(r-EPO) . The hospital pharmacist will make the solution using sterile technique and The solution contained contains ; 115 meq/l sodium chloride, 17 meq/L sodium acetate, and 4 meq/l potassium chloride. Human serum albumin (5%) will be added to the infusion bag (final concentration of albumin=0.05%). Aliquots (10 ml) will be frozen until use. Solution in the syringe will be pushed through the orogastric tube prior to insertion into the patient in order to reduce binding of rEpo to the plastic tubing. Upon enrollment of a subject a full day's dose will be thawed. The full day's dose ( 5 Ml/Kg/D) will then be divided into 3 equal amounts, to be administered by the bedside nurse every 8 hours. Each aliquot will allow warming to room temperature before it will administer. They will also receive feeding with breast milk after giving the fluid. The nurse of the patient and the person who are responsible for data collection will be blind to the group of the patients and the solutions.
public Dr.Mohammad Bagher Hosseini
Alzahra Teaching Hospital,Neonatal Unit
Tabriz Iran (Islamic Republic of) +98 41 1335 0357 hosseini_mb@yahoo.com Tabriz University of Medical Sceinces scientific Dr.Mohammad Bagher Hosseini
Alzahra teaching Hospital,Neonatal Unit
Tabriz Iran (Islamic Republic of) +98 41 1335 0357 hosseini_mb@yahoo.com Tabriz University Of Medical Sceinces Iran (Islamic Republic of) Patients will eligible if they are inborn preterm infants with gestational age of 28 weeks or less or Birth weight 1250 gram or less and they are Appropriate for Gestational Age. Patients will consider ineligible if they have any congenital anomaly of the gastrointestinal tract (i.e., omphalocele, gastroschisis, tracheoesophageal fistula, intestinal perforation), or have other major congenital anomalies (congenital heart disease, neural tube defect, congenital diaphragmatic hernia, Trisomy, etc.).They Also will exclude if the neonates judge as being too ill to be acceptable study candidates; this criterion will set as receiving mechanical ventilation with an FIO2>0.60 no limit 1 year Both p77 Necrotizing Enterocolitis of fetus and neonate Treatment - Drugs Treatment - Drugs Treatment - Drugs In Control group of the patients breast milk will be started and increase according the routine guideline of the unit without any solutions The first group of the (case) patients will receive the synthetic Amniotic fluid solution with Recombinant Erythropoietin(r-EPO) . The hospital pharmacist will make the solution using sterile technique and The solution contained contains ; 115 meq/l sodium chloride, 17 meq/L sodium acetate, and 4 meq/l potassium chloride,4400 mU/ml Epoetin alfa (Epogen, Amgen). Human serum albumin (5%) will be added to the infusion bag prior to the addition of the rEPO (final concentration of albumin=0.05%). The fluid contain a 10-fold higher concentration of Epo than natural amniotic fluid . Aliquots (10 ml) will be frozen until use. Solution in the syringe will be pushed through the orogastric tube prior to insertion into the patient in order to reduce binding of rEpo to the plastic tubing. Upon enrollment of a subject a full day's dose will thawed. The full day's dose (5 Ml/Kg/D will then be divided into 3 equal amounts, to be administered by the bedside nurse every 8 hours. Each aliquot will allow warming to room temperature before it will administer. They will also receive feeding with breast milk after giving the fluid. The nurse of the patient and the person who are responsible for data collection will be blind to the group of the patients and the solutions. The second group of the(case) patients will receive the synthetic Amniotic fluid solution without Recombinant Erythropoietin(r-EPO) . The hospital pharmacist will make the solution using sterile technique and The solution contained contains ; 115 meq/l sodium chloride, 17 meq/L sodium acetate, and 4 meq/l potassium chloride. Human serum albumin (5%) will be added to the infusion bag (final concentration of albumin=0.05%). Aliquots (10 ml) will be frozen until use. Solution in the syringe will be pushed through the orogastric tube prior to insertion into the patient in order to reduce binding of rEpo to the plastic tubing. Upon enrollment of a subject a full day's dose will be thawed. The full day's dose ( 5 Ml/Kg/D) will then be divided into 3 equal amounts, to be administered by the bedside nurse every 8 hours. Each aliquot will allow warming to room temperature before it will administer. They will also receive feeding with breast milk after giving the fluid. The nurse of the patient and the person who are responsible for data collection will be blind to the group of the patients and the solutions. Frequency of Necrotizing Enterocolitis. Timepoint: After third days of birth until discharge from hospital or death. Method of measurement: Clinical evaluation and radiologic finding. Mortality rate. Timepoint: After third days of birth until discharge from hospital or death. Method of measurement: Clinical evaluation. Tolerance data included the occurrence of emesis, gastric residuals, diarrhea, bloody stools, abdominal distention. Timepoint: After third days of birth until discharge from hospital or death. Method of measurement: Clinical evaluaion and measurement of abdominal circumference). Frequency of Retinopathy Of Prematurity. Timepoint: After 4 weeks of birth. Method of measurement: Ophtalmologic exam by Retinologist. Frequency of Chronic Lung Disease. Timepoint: After 28 days of birth. Method of measurement: Clinical evaluation of needs of oxygen or respratory support. Frequency of Intraventricular Hemorrage ( IVH). Timepoint: After one mounths of age. Method of measurement: Ultrasonography by radiologist. Pediatric Health Research Center of Tabriz University of Medical Sceinces Approved 2013-11-18 Tabriz University of Medical Sceinces Central building 2, Golgasht Street, Research and Technology Department of Tabriz University of Medical Sciences Tabriz Iran (Islamic Republic of)