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Anthropometric Outcome and Edema in Low Birth Weight Infants Treated With Erythropoietin

Protocol summary

Study aim
Determining the effect of erythropoietin treatment in low birth weight infants height, weight, headache, and neonatal edema
Design
A randomized clinical trial with a control group, parallel groups, phase 3, on 80 infants. Lottery is used for randomization.
Settings and conduct
Birth weight, height, and head circumference are measured. In the test group one week after the birth, RETIC and CBCdiff are checks and two weeks after birth Erythropoietin injection, three times a week for a month (12 times) dose of 100 units per kilogram of 2000 units ampules with subcutaneous injection of the baby's arm, two One week after the last Erythropoietin injection, the labels will be checked again and in the control group without injection. The experiments will be performed in the first two weeks and 40 days. After injection, the side-effects of Erythropoietin injection include an allergic reaction and problems with the injection. In both groups, the drug is held daily at the time of hospitalization. After discharge, the drug checks on time for injection, and the last time by the time of the trial.
Participants/Inclusion and exclusion criteria
Admission: age less than 35 weeks, birth weight less than 2000 g, no disease Withdrawal: anomaly, sepsis, thrombocytopenia, diastolic more than 60 mg, shock, hydrops, trisomies, seizures, hemolytic diseases
Intervention groups
Injecting erythropoietin in the intervention group for 12 sessions and checking its outcome in forty days and not intervening in the control group.
Main outcome variables
Improvement in the infant's recovery, infant's sucking and swallowing power, infant's general condition, prevention of neonatal apnea, improved neonatal anthropometric criteria, and decreased edema.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160511027853N2
Registration date: 2020-05-31, 1399/03/11
Registration timing: registered_while_recruiting

Last update: 2020-05-31, 1399/03/11
Update count: 0
Registration date
2020-05-31, 1399/03/11
Registrant information
Name
Farahnaz Mohammadkhaniha
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3314 8318
Email address
fmohammadkhaniha.nurse92@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-07-05, 1399/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Anthropometric Outcome and Edema in Low Birth Weight Infants Treated With Erythropoietin
Public title
"Evaluation of the effect of Erythropoietin on Antropometric results";"Evaluation of the effect of Erythropoietin on Edema"
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Premature birth with gestational age at birth less than 35 weeks Birth weight less than 2000 grams No illness (healthy babies who experience no problems or sickness in the first week of birth).
Exclusion criteria:
Congenital anomalies depression thrombocytopenia diastolic pressure greater than 60 mmHg shock hydrops fetalis threesomes seizures hemolytic diseases.
Age
From 7 days old to 40 days old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, with a sample size of 80 neonates, 40 balls for the intervention group, and 40 balls for the control group are placed in a lottery container, and then the balls are randomly removed from the container without replacement and the created sequence is recorded.
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
Ethics committee of Qazvin University of Medical Sciences
Street address
Kosar Hospital, Taleqani Ave,Qazvin,Iran
City
Qazvin
Province
Qazvin
Postal code
3415613176
Approval date
2019-12-14, 1398/09/23
Ethics committee reference number
IR.QUMS.REC.1398.133

Health conditions studied

1

Description of health condition studied
prematurity
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Around the head
Timepoint
Birth, one week after birth, two weeks after birth, forty days after birth
Method of measurement
Tape Measure

2

Description
Weight
Timepoint
Birth, one week after birth, two weeks after birth, forty days after birth
Method of measurement
Baby digital scale with SCEA brand, Model 374, which weighs 5 grams

3

Description
Edema
Timepoint
daily
Method of measurement
Pitting Edema Grading Scale

4

Description
Height
Timepoint
Birth day and forty day of birth
Method of measurement
Tape Measure

Secondary outcomes

1

Description
The general condition of the neonate
Timepoint
every hour
Method of measurement
General examination of infants in terms of tachypnea, cyanosis, lactation, excretion, weight gain

Intervention groups

1

Description
Intervention group: Anthropometric characteristics of infants include birth weight, height, and head circumference. The RETIC and CBCdiff are tested one week after birth. Two weeks after birth, Erythropoietin is given three times a week for a month (12 times). The 2000 u Erythropoietin ampule produced by Sinagen Pharmaceutical Company is used, 100 units per kilogram for each baby. The tests are re-checked two weeks after the last Erythropoietin injection. In the control group, without drug injection, the tests are performed at 14 and 40 days of age. After the injection, the injection side-effects and edema are examined. Finally, the anthropometric tests and criteria are compared before and after the intervention. If Erythropoietin is effective, the primary consequences are increased in neonatal improvements, such as sucking and swallowing power, secondary outcomes, including; improved neonatal general condition, prevention of neonatal apnea, improved neonatal anthropometric criteria, and reduced edema.
Category
Treatment - Drugs

2

Description
Control group: These babies are prone to infection and malaise due to their pre-term. At the discretion of the Clinical Ethics Committee, no placebo is used for this group and they receive routine treatment.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Kosar Educational and Medical Center
Full name of responsible person
Dr. Seyed Hooshyar Mojabi
Street address
Qazvin ,Taleghani Ave. Kosar Educational and Medical Center
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3323 6380
Fax
Email
mojabi1355@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Mohammad Mehdi Imam Jomeh
Street address
Shahid Beheshti Blvd, Movadat Subdivision - Qazvin University of Medical Sciences Vice Chancellor for Research and Technology
City
Qazvin
Province
Qazvin
Postal code
13911/34156
Phone
+98 28 3335 7039
Email
memamjomeh@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Farahnaz Mohammadkhaniha
Position
Educational Supervisor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Kosar Educational and Medical Center،Taleghani Ave،Qazvin
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3323 6380
Fax
+98 28 3324 2661
Email
farahnaz.mohammadkhaniha@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Seyed Hoshyar Mojabi
Position
Non-faculty subspecialty
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Kosar Educational and Medical Center, Taleghani Ave,Qazvin
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3323 6380
Fax
+98 28 3324 2661
Email
mogabi1355@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Farahnaz Mohammadkhaniha
Position
Educational Supervisor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Kosar Educational and Medical Center, Taleghani Ave ,Qazvin
City
Qaazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3323 6380
Fax
+98 28 3324 2661
Email
farahnaz.mohammadkhaniha@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All potential data can be shared after people have not been identified
When the data will become available and for how long
Start accessing data immediately after the article is published
To whom data/document is available
It will only be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
There are no other conditions
From where data/document is obtainable
Refer to Dr. Seyed Hoshyar Mojabi
What processes are involved for a request to access data/document
Giving an email to Dr. Seyed Hoshyar Mojabi and answering within a week at most
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