The aim of the study is evaluation of the Enteral Recombinant Erythropoietin(rEpo) in prevention of Necrotizing Entrocolits(NEC) in premature infants. Preterm infants who are inborn with gestational age 28 weeks or less or Birth weight 1250 gram or less and they are Appropriate for Gestational Age, without any major congenital anomaly will be recruited. After receiving the consent of the parents the patients will be divided randomly in 3 groups. Two groups of preterm infants consisting of 35 in each group will receive 5mL enterally of the study solution (synthetic Amniotic Fluid)/kg/day divided into 3dosing. Case group (Group 1) will receive the fluid containing rEpo . Another group(Group2) will receive the solution without rEpo . The fluid will be started after3 days of birth and will continue until 3 weeks. They will also receive feeding with breast milk after giving the fluid .In 35 of the preterm infants as Control group breast milk will start and increase according the routine guideline of the unit without any solution .The patients in 3 groups will follow until discharge or death and compare to frequency of NEC or mortality.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201310164113N4
Registration date:2014-02-07, 1392/11/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-02-07, 1392/11/18
Registrant information
Name
Mohammad Bagher Hosseini
Name of organization / entity
Tabriz Universisty of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
hossainm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Pediatric Health Research center of Tabriz
Expected recruitment start date
2014-01-21, 1392/11/01
Expected recruitment end date
2014-09-21, 1393/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Enteral Recombinant Erythropoietin(R-EPO) in prevention of Necrotizing Entrocolits in Very Low Birth Weight infants
Public title
Evaluation of Enteral Erythropoietin in prevention of Necrotizing Entrocolits in Very Low Birth Weight infants
Purpose
Prevention
Inclusion/Exclusion 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
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sceinces
Street address
Central building 2, Golgasht Street, Research and Technology Department of Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2013-11-18, 1392/08/27
Ethics committee reference number
92120
Health conditions studied
1
Description of health condition studied
Necrotizing Enterocolitis of fetus and neonate
ICD-10 code
p77
ICD-10 code description
Necrotizing Enterocolitis of fetus and neonate
Primary outcomes
1
Description
Frequency of Necrotizing Enterocolitis
Timepoint
After third days of birth until discharge from hospital or death
Method of measurement
Clinical evaluation and radiologic finding
2
Description
Mortality rate
Timepoint
After third days of birth until discharge from hospital or death
Method of measurement
Clinical evaluation
3
Description
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 outcomes
1
Description
Frequency of Retinopathy Of Prematurity
Timepoint
After 4 weeks of birth
Method of measurement
Ophtalmologic exam by Retinologist
2
Description
Frequency of Chronic Lung Disease
Timepoint
After 28 days of birth
Method of measurement
Clinical evaluation of needs of oxygen or respratory support
3
Description
Frequency of Intraventricular Hemorrage ( IVH)
Timepoint
After one mounths of age
Method of measurement
Ultrasonography by radiologist
Intervention groups
1
Description
In Control group of the patients breast milk will be started and increase according the routine guideline of the unit without any solutions
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
3
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Teaching Hospital
Full name of responsible person
Dr. Mohammad Bagher Hosseini
Street address
Artesh street.Azadei Ave
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pediatric Health Research Center of Tabriz University of Medical Sceinces
Full name of responsible person
Dr.Mohammad Barzegar
Street address
Children Hospital
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pediatric Health Research Center of Tabriz University of Medical Sceinces
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sceinces
Full name of responsible person
Dr.Mohammad Bagher Hosseini
Position
Associate Professor
Other areas of specialty/work
Street address
Alzahra Teaching Hospital,Neonatal Unit
City
Tabriz
Postal code
Phone
+98 41 1335 0357
Fax
Email
hosseini_mb@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University Of Medical Sceinces
Full name of responsible person
Dr.Mohammad Bagher Hosseini
Position
Associate Professor
Other areas of specialty/work
Street address
Alzahra teaching Hospital,Neonatal Unit
City
Tabriz
Postal code
Phone
+98 41 1335 0357
Fax
Email
hosseini_mb@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sceinces
Full name of responsible person
Dr.Mohammad Bagher Hosseini
Position
Associate Professor
Other areas of specialty/work
Street address
Alzahra Teaching Hospital,Neonatal Unit
City
Tabriz
Postal code
Phone
+98 41 1335 0357
Fax
Email
hosseini_mb@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)