This is a prospective study that determined the effect of erythropoietin in treatment of anemia of prematurity in newborns that were discharged from NICU of Emamreza hospital. We included premature infants who had Hct<30% in second week or Hct <25% in third week. Intervention group received erythropoietin 500 unite/kg twice in week along with supplementary iron. Control group received only supplementary iron for 4 weeks. Hematocrite and reticulocyte count checked at the beginning, third day after the start and one week after the end of treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138711031162N10
Registration date:2009-04-01, 1388/01/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-04-01, 1388/01/12
Registrant information
Name
Ashraf Mohammadzadeh
Name of organization / entity
Neonatal Research Center of Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1852 1121
Email address
mohamadzadeha@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of medical sciences
Expected recruitment start date
2001-05-04, 1380/02/14
Expected recruitment end date
2002-05-04, 1381/02/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Erythropoietin on the treatment of Anemia of prematurity
Public title
Effect of Erythropoietin on the treatment of Anemia of prematurity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Gestational age less than 34 weeks, breast milk feeding, hematocrite <30% when infants age was between 2 to 3 weeks or HCT<25% when infants age was more than 3 weeks. Exclusion criteria: Infants with hemolytic anemia, active bleeding or congenital malformation.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice chancellor for research of Mashhad University of medical sciences
Street address
Ghoreshi building, Daneshgah street
City
Mashhad
Postal code
13131-91379
Approval date
2002-08-05, 1381/05/14
Ethics committee reference number
1427 ت
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
Hemotocrite and reticulocyte count
Timepoint
at the beginning, third day from the start day and one week after the end of treatment
Method of measurement
venous sampling
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: erythropoietin 500 unite/kg twice in week along with supplementary iron
Category
Treatment - Drugs
2
Description
Control group: only supplementary iron for 4 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
NICU of Emamreza hospital
Full name of responsible person
Dr.Ashraf mohammadzadeh
Street address
Neonatal research center- NICU- Emamreza hospital-mashhad-Iran
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of medical sciences
Full name of responsible person
Dr jalil tavakol afshari
Street address
Ghoreshi bulding-Daneshgah street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Neonatal Research Center
Full name of responsible person
Dr. Ashraf mohammadzadeh
Position
Neonatologist, professor
Other areas of specialty/work
Street address
NRC-NICU-Emamreza hospital
City
Mashhad
Postal code
9137913316
Phone
+98 51 1852 1121
Fax
+98 51 1852 5316
Email
mohamadzadeha@mums.ac.ir
Web page address
www.mums.ac.ir/nrc
Person responsible for scientific inquiries
Contact
Name of organization / entity
Neonatal Research Center
Full name of responsible person
Dr. Ashraf mohammadzadeh
Position
Neonatologist, professor
Other areas of specialty/work
Street address
NRC-NICU-Emamreza hospital
City
Mashhad
Postal code
9137913316
Phone
+98 51 1852 1121
Fax
+98 51 1852 5316
Email
mohamadzadeha@mums.ac.ir
Web page address
www.mums.ac.ir/nrc
Person responsible for updating data
Contact
Name of organization / entity
Neonatal Research Center
Full name of responsible person
Dr.Ashraf mohammadzadeh
Position
Neonatologist, professor
Other areas of specialty/work
Street address
NRC-NICU-Emamreza hospital
City
Mashhad
Postal code
9137913316
Phone
+98 51 1852 1121
Fax
+98 51 1852 5316
Email
mohamadzadeha@mums.ac.ir
Web page address
www.mums.ac.ir/nrc
Sharing plan
Deidentified Individual Participant Data Set (IPD)