Background& Objectives: Binding indirect bilirubin to the neuronal membranes receptors such as N-methyl-Daspartate causes permanent injuries. Magnesium (Mg) ion is proposed to be one of the most important antagonistic regulators of this receptor. We aim to investigate the relationship between serum levels of total magnesium and bilirubin before and after phototherapy in term neonates. It can help to find new therapeutic and management techniques and the best time for discharge.
Design&Setting: In this semi-experimental, we study icteric neonates admitted to Zahedan Imam Ali hospital from March 2009 to March 2010.
Inclusion criteria: 90 otherwise-healthy term newborns with nonhemolytic hyperbilirubinemia during the first 4 weeks of life according to their age and standard graphs
Exclusion criteria: Those neonates with anemia(Hb<8 ); symptoms in favor of hemolysis (ABO or Rh mismatch, G6PD deficiency, positive direct coombs test); history of Mg sulfate administration in mother and symptoms and signs in favor of infections; metabolic or endocrine disorders.
Intervention& outcome: After complete physical examination, venous blood samples when indicated will be taken for the laboratory characteristics. Hyperbilirubinemia severity groups will be mild (14-16 mg per dL), moderate (16-18 mg per dL), and severe (≥18 mg per dL) respectively. After necessary recommendations phototherapy will be applied for the breast-fed newborns with exaggerated bilirubin concentrations and those for whom initial interventions could not decline their elevating bilirubin levels. Forty-eight hours after phototherapy, the same measurement for tMg and total serum bilirubin will be performed.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2015090823942N1
Registration date:2016-03-22, 1395/01/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-03-22, 1395/01/03
Registrant information
Name
Mehdi Shiri
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5560 9951
Email address
m_shiri@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research of Zahedan University of Medical Sciences
Expected recruitment start date
2010-04-04, 1389/01/15
Expected recruitment end date
2011-03-06, 1389/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of total serum magnesium concentrations in neonatal hyperbilirubinemia before and after phototherapy
Public title
Total serum magnesium in the icteric neonates before and after phototherapy
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria: 90 otherwise-healthy term newborns with nonhemolytic hyperbilirubinemia during the first 4 weeks of life according to their age and standard graphs
Exclusion criteria:Those neonates with anemia(Hb<8 ); symptoms in favor of hemolysis (ABO or Rh mismatch, G6PD deficiency, positive direct coombs test); history of Mg sulfate administration in mother and symptoms/signs in favor of infections; metabolic and endocrine disorders
Age
From 1 day old to 15 days old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
To investigate total plasma levels of magnesium (tMg) in neonatal hyperbilirubinemia; before and after phototherapy serum bilirubin and plasma tMg will be measured in 90 otherwise-healthy term newborns with nonhemolytic hyperbilirubinemia
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee with supervision of Vice-chancellor for Research of Zahedan University of Medical S
Street address
Hesabi sq.
City
Zahedan
Postal code
98167-43463
Approval date
2010-10-20, 1389/07/28
Ethics committee reference number
IR.ZAUMS.REC.1389.2134
Health conditions studied
1
Description of health condition studied
Neonatal jaundice
ICD-10 code
P59.9
ICD-10 code description
Physiological jaundice (intense)(prolonged) NOS
Primary outcomes
1
Description
Total serum bilirubin
Timepoint
Before and after phototherapy
Method of measurement
Spectrophotometry
Secondary outcomes
1
Description
Total serum magnesium
Timepoint
Before and after phototherapy
Method of measurement
Atomic absorption
Intervention groups
1
Description
Intervention group: The breast-fed newborns with exaggerated Bilirubin levels and those for whom initial managements could not decline increasing Bilirubin loads, phototherapy was employed based on the neonates’ age and Bilirubin levels.Forty-eight hours after phototherapy, the same measurement for tMg and total Serum Bilirubin was performed.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan Imam Ali hospital
Full name of responsible person
Mahmood Rezaee-pour
Street address
City
Zahedan
2
Recruitment center
Name of recruitment center
Aliasghar Pediatrics hospital
Full name of responsible person
Mehdi Shiri
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research of Zahedan University of Medical Sciences
Full name of responsible person
Mahmood Imani
Street address
Hesabi Sq.
City
Zahedan
Grant name
Grant code / Reference number
ت/447
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research of Zahedan 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
Razi hospital, Department of Dermatology, Tehran University of Medical Sciences
Full name of responsible person
Mehdi Shiri
Position
M.D.
Other areas of specialty/work
Street address
Razi Hospital,Vahdat_e_eslami st.
City
Tehran
Postal code
1199663911
Phone
+98 21 5560 9951
Fax
Email
msh.iums@gmail.com
Web page address
www.tums.ac.ir/razi
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Pediatrics, Zahedan University of Medical Sciences
Full name of responsible person
Mahmood Rezaee-pour
Position
M.D.
Other areas of specialty/work
Street address
HESABI SQ.
City
Zahedan
Postal code
Phone
+98 54 3341 6703
Fax
Email
m.rezaypoor48@yahoo.com
Web page address
http://www.zaums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Razi hospital, Department of Dermatology, Tehran University of Medical Sciences
Full name of responsible person
Mehdi Shiri
Position
M.D.
Other areas of specialty/work
Street address
Vahdat_e_eslami st.
City
Tehran
Postal code
1199663911
Phone
+98 21 5560 9951
Fax
Email
msh.iums@gmail.com
Web page address
www.tums.ac.ir/razi
Sharing plan
Deidentified Individual Participant Data Set (IPD)