Necrotizing Enterocolitis of fetus and neonate. Necrotizing Enterocolitis of fetus and neonate
Conditions
Interventions
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 (ca
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 addi
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)
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 tech
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 te
Sponsors
Pediatric Health Research Center of Tabriz University of Medical Sceinces
Eligibility
Sex/Gender
All
Age
No minimum to 1 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr.Mohammad Bagher Hosseini
Tabriz University of Medical Sceinces
Outcome results
None listed