Premature infants with very low birth weight often develop anemia that need to transfusion and blood transfusion have its side effects. The exogen human erythropoietin is used for preventing and treating anemia of prematurity. In this research we study the effect of recombinant human erythropoietin in reducing need to transfusion in very-low-birth-weight infants. Material and Methods: This study is performed in NICU of Fatemieh hospital, Hamadan, Iran. Thirty neonate with birth weight less than 1500 grams and gestational age equal or less than 31 weeks, who have hematocrit less than 40% and receive at least 50% of their calories by enteral route, are included and randomly divided to two groups: intervention and control (15 patients in each group). In control group, ferrous sulfate drop (4mg/kg/day) is administered and in intervention group, in addition to ferrous sulfate drop, Eprex 2000 IU- 250 IU/kg three times in a week is administered subcutaneously. Hemoglobin and hematocrit and reticulocyte count and patient's weight are recorded at the first of study and the end of first and second and third weeks of study. Need to transfusion and its times will be recorded in each group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112265110N2
Registration date:2012-03-22, 1391/01/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-03-22, 1391/01/03
Registrant information
Name
Behnaz Basiri
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1821 3770
Email address
b.basiri@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2008-12-08, 1387/09/18
Expected recruitment end date
2010-03-09, 1388/12/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Human Recombinant Erythropoietin on Reducing Need to Blood Transfusion in Very-Low-Birth-Weight Infants
Public title
The Effect of Erythropoeitin on Anemia of Prematurity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Neonates with birth weight less than 1500 gram; gestational age less than 31 weeks; post natal age at Least 6 days; received calories at least 50 Kcal/kg, at Least 50% in enteral route; Hct=< 40%. Exclusion criteria: Severe congenital anomalies, dysmorphic syndromes; hemolytic anemia; severe acute infections.
Age
From 6 years old to 28 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Fahmideh Street
City
Hamadan
Postal code
65178/518
Approval date
2011-05-29, 1390/03/08
Ethics committee reference number
783/9/35/16/پ/د
Health conditions studied
1
Description of health condition studied
Anemia of Prematurity
ICD-10 code
P61.2
ICD-10 code description
Anaemia of prematurity
Primary outcomes
1
Description
Need to transfusion
Timepoint
At the end of treatment
Method of measurement
The number of transfusions
Secondary outcomes
1
Description
Hemoglobin, Hematocrit, Reticulocyte count
Timepoint
Weekly
Method of measurement
CBC
2
Description
Weight of neonate
Timepoint
weekly
Method of measurement
Seca scale
Intervention groups
1
Description
Intervention group: Eprex 2000 IU Ampule 250 IU/kg 3 Times in a Week s/c and ferrous sulfate drop 4 mg/kg/ day
Category
Treatment - Drugs
2
Description
Control group: Administration of Ferrous Sulfate Drop 4mg/kg
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Dr. Behnaz Basiri
Street address
Pasdaran Street
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Tchnology, Hamadan University of Medical Sciences
Full name of responsible person
Mis. Asgarnia
Street address
Hamadan University Of Medical Science, Fahmideh Street
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Tchnology, Hamadan University of Medical Sciences
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
Hamadan University of Medical Sciences
Full name of responsible person
Dr.Behnaz Basiri
Position
Neonatologist
Other areas of specialty/work
Street address
NICU, Fatemieh Hospital, Pasdaran Street
City
Hamadan
Postal code
6517789975
Phone
+98 81 1827 7082
Fax
Email
b.basiri@umsha.ac.irbehnazbasiri@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr.Behnaz Basiri
Position
Neonatologist
Other areas of specialty/work
Street address
NICU, Fatemieh Hospital, Pasdaran Street
City
Hamadan
Postal code
6517789975
Phone
+98 81 1827 7082
Fax
Email
b.basiri@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)