Background: Newborns have a limited amount of antioxidant protection. Exchange transfusion may affect Prooxidant-Antioxidant Balance (PAB). The present study is conducted to investigate the effect of the exchange transfusion on PAB in newborns jaundice.
Methods: the present study is based on a clinical trial which is conducted in Qaem hospital in Mashhad in 2015-2016 with sampling available on 22 newborns jaundice over 35 weeks with high bilirubin 17 mg / dl who were jaundiced. The instrument of collecting data of the questionnaire of the researcher included maternal blood group and neonatal characteristics (age, sex, weight, gestational age, Apgar score) and laboratory assessment (bilirubin, hematocrit, direct and indirect Coombs, reticulocytes, G6PD, T4, TSH and PAB). The amount of PAB and total serum bilirubin level (STB) of newborns before, after and 6 hours after the exchange transfusion were investigated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016112812197N6
Registration date:2016-12-24, 1395/10/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-24, 1395/10/04
Registrant information
Name
Maryam Zakerihamidi
Name of organization / entity
Tonekabon Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 19 1224 5014
Email address
maryamzakerihamidi@yahoo.co.nz
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2014-07-12, 1393/04/21
Expected recruitment end date
2015-05-08, 1394/02/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To Investigate the Effect of Exchange Transfusion on Prooxidant-Antioxidant Balance (PAB) in Newborns Jaundice
Public title
The Effect of Exchange Transfusion on Prooxidant-Antioxidant Balance
Purpose
Treatment
Inclusion/Exclusion criteria
In this study, the newborns to term and near-term (over 35 weeks) were selected with available sampling. The newborns were enrolled studied after the consent of the parents.
Exclusion criteria for studying included severe birth defects; birth asphyxia; respiratory distress; even mild or transient; sepsis; Rh incompatibility and ABO; direct Coombs test positive; maternal diabetes and preeclampsia / eclampsia.
Age
From 2 days old to 10 days old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
22
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad university of Medical Sciences
Street address
Mashhad- Chahar Rahe Doktora- Mashhad university of Medical Sciences
City
Mashhad
Postal code
Approval date
2014-07-12, 1393/04/21
Ethics committee reference number
930179
Health conditions studied
1
Description of health condition studied
Hyperbilirubinemia
ICD-10 code
P59.0
ICD-10 code description
Neonatal jaundice associated with preterm delivery
Primary outcomes
1
Description
Prooxidant-Antioxidant Balance (PAB)
Timepoint
before, after and 6 hours after the exchange transfusion
Method of measurement
Prooxidant-Antioxidant Balance is considered by TMB in two different reactions
Secondary outcomes
empty
Intervention groups
1
Description
Blood Exchange
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashahd University of Medical Sciences
Full name of responsible person
Research deputy of Mashahd University of Medical Sciences
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Research deputy of Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Mashhad, IRAN.
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
Tonekabon Islamic Azad University
Full name of responsible person
Maryam Zakerihamidi
Position
PhD
Other areas of specialty/work
Street address
no 251, Laleh Blind Alley, Golesorkhi St., Chaloos, Iran
City
Chaloos
Postal code
Phone
+98 11 5224 5014
Fax
Email
maryamzakerihamidi@yahoo.co.nz
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Zakerihamidi
Position
PhD
Other areas of specialty/work
Street address
Tonekabon Islamic Azad University, Tonekabon, Iran
City
Tonekabon
Postal code
Phone
+98 11 5427 1105
Fax
Email
maryamzakerihamidi@yahoo.co.nz
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tonekabon Islamic Azad Uniersity
Full name of responsible person
Maryam Zakerihamidi
Position
PhD/Faculty member
Other areas of specialty/work
Street address
no 251, Laleh Blind Alley, Golesorkhi St., Chaloos
City
Chaloos
Postal code
4661734666
Phone
+98 11 5224 5014
Fax
Email
maryamzakerihamidi@yahoo.co.nz
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)