Objective: The effect of early erythropoietin administration on erythropoiesis in preterm infants. Sample size: This study is doing on the 44 infants that they will born in the Afzalipour hospital, Kerman, Iran. Inclusion Criteria: premature infants with birth weight<1800g and gestational age<34week that their cardiorespiratory condition are stable. Exclusion Criteria: a major congenital malformation, severe asphyxia, a positive direct antiglobulin test with clinical symptom of hemolytic anemia, surgical problems, exchange transfusion, dependent on mechanical ventilation. Intervention: Treated infants receive 500 u/kg/wk rhu EPO, 2 times weekly, administered subcutaneously in lateral side of thigh. Infants in control group don’t receive placebo. Treatment continues until 4 weeks after beginning. Treated and control infants receive 3 mg/kg/day iron (ferrous sulfate) single dose enterally. All patients receive enteral supplements of folic acid (50μg/day), 1ml vit A+D /day and 1ml vit E/day. Transfusion information will be recorded in both groups of infants from birth to study completion. Complete blood cells counts with differentials and reticulocyte counts will be performed by Coulter counter in both groups in the beginning and end of study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201008091380N2
Registration date:2010-10-30, 1389/08/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-10-30, 1389/08/08
Registrant information
Name
Mahmood Noori-Shadkam
Name of organization / entity
Shahid Sadoghi university
Country
Iran (Islamic Republic of)
Phone
+98 35 1724 7074
Email address
noori@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2010-08-23, 1389/06/01
Expected recruitment end date
2010-11-21, 1389/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of early erythropoietin administration on erythropoiesis in preterm infants
Public title
The effect of erythropoietin on the erythropoiesis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: premature infants with birth weight<1800g and gestational age<34week that their cardiorespiratory condition were stable. Exclusion criteria: a major congenital malformation, evidence of coagulopathy, severe asphyxia, intraventricular hemorrhage grade 3-4, a positive direct antiglobulin test with clinical symptom of hemolytic anemia, surgical problems, exchange transfusion, severe cardiopulmonary disease required > 40% head box oxygen or dependent on mechanical ventilation, systolic blood pressure > 100mm Hg , an absolute neutrophil counts (ANC) of ≤ 500/μl.
Age
To 1 year old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
44
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
Kerman University of Medical Sciences
Street address
Islamic Republic Blv.
City
Kerman
Postal code
Approval date
2010-05-20, 1389/02/30
Ethics committee reference number
k/89/43
Health conditions studied
1
Description of health condition studied
Anaemia of prematurity
ICD-10 code
P61.2
ICD-10 code description
Anaemia of prematurity
Primary outcomes
1
Description
hematocrit
Timepoint
at the beginning and end of study
Method of measurement
with colter counter
Secondary outcomes
1
Description
pack cell transfusion
Timepoint
at the end of study
Method of measurement
ml
2
Description
Ferritin
Timepoint
begining and end of study
Method of measurement
Radioimunoassay
3
Description
Reticulocyte
Timepoint
begining and end of study
Method of measurement
Microscope
4
Description
Mean daily weight gain
Timepoint
begining and end of study
Method of measurement
Weigher
Intervention groups
1
Description
Infants in control group don’t receive placebo. Control infants receive 3 mg/kg/day elemental iron once a day enterally. In all infants minimal the enteral intake at the end of first week of age is 50ml/ kg, and all patients receive enteral supplements of folic acid (50μg/day), 1ml vit A+D /day (1mililiter containing vitamin: A, 1500IU, vitamin D 400U) and 1ml/day vit E.
Category
Prevention
2
Description
Treated infants receive 500 u/kg/wk rhu EPO, 2 times weekly, administer subcutaneously in lateral side of thight. Treatment continue untile 4 weeks after beginning. Criteria for withholding / stopping the study drug included: neutropenia (ANC<500/μl) or hypertension (defined as a systolic blood pressure > 100mmHg during the first 2 post natal weeks and > 120 mmHg thereafter). Drug is restarted when these conditions resolve. Treatment stops when clinical seizures occur or when hypertension or neutropenia persist. Treated infants receive 3 mg/kg/day iron (ferrous sulfate) single dose enterally. In all infants minimal the enteral intake at the end of first week of age is 50ml/ kg and all patients receive enteral supplements of folic acid (50μg/day), 1ml vit A+D /day (1mililiter containing vitamin: A, 1500IU, vitamin D 400U) and 1ml/day vit E.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour Hospital
Full name of responsible person
Noori-Shadkam M.
Street address
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Malekpour-Afshar R.
Street address
Kerman University of Medical Sciences
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Noori-Shakam M.
Position
Neonatologist
Other areas of specialty/work
Street address
Afzalipour hospital
City
Kerman
Postal code
Phone
+98 34 1322 2269
Fax
Email
noori@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Niknafs P.
Position
Neonatologist
Other areas of specialty/work
Street address
Afzalipour Hospital
City
Kerman
Postal code
Phone
+98 34 1322 2269
Fax
Email
pniknafs@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Noori-Shadkam M.
Position
Neonatologist
Other areas of specialty/work
Street address
City
Kerman
Postal code
Phone
+98 34 1322 2269
Fax
Email
noori@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)