The effect of phototherapy on serum 25 hydroxyvitamin D levels in neonatal hyperbilirubinemia
Design
All the newborns with an age of more than 72 hours that had been referred to Amirkola Children's Hospital (ACH) with serum bilirubin level more than 15mg/dl have been considered as the case group and received phototherapy according to the ACH phototherapy protocol. Bilirubin was cheeked by spectrophotometry method by chemical kits and serum 25(OH) vitamin D level was checked by ELISA; in two times before phototherapy and 72 hours after the start of phototherapy
The primary consequences: Determination of serum 25(OH) vitamin D levels. The secondary consequence: Determination of serum bilirubin level that would be compared before and after the intervention.
Settings and conduct
All the newborns with an age of more than 72 hours that had been referred to Amirkola Children's Hospital (ACH)
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Term infants (weight: 2500–4000 g) who required phototherapy, Infant From 3 day old to 28 days old
Exclusion Criteria: Infants with congenital anomalies Asphyxia prenatal (birth, APGAR score less than 4 at 1 minute or less than 7 at 5 minutes of birth, Incidence of clinical signs of sepsis or blood cultures during phototherapy, the need for blood transfusions during the study, Incidence clinical benefit of Kernicterus
Intervention groups
Get a phototherapy at a distance of 20 centimeters from the body surface
Main outcome variables
serum 25 hydroxyvitamin D levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180925041133N1
Registration date:2018-10-08, 1397/07/16
Registration timing:registered_while_recruiting
Last update:2018-10-08, 1397/07/16
Update count:0
Registration date
2018-10-08, 1397/07/16
Registrant information
Name
Yadollah Zahedpasha
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3234 2151
Email address
y.zahedpasha@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of phototherapy on serum 25(OH) vitamin D level in neonatal hyperbilirubinemia
Public title
The effect of phototherapy on serum vitamin D level in neonatal hyperbilirubinemia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Term infants (weight: 2500–4000 g) who required phototherapy
From 3 day old to 28 days old
Exclusion criteria:
Infants with congenital anomalies
Asphyxia prenatal (birth, APGAR score less than 4 at 1 minute or less than 7 at 5 minutes of birth
Incidence of clinical signs of sepsis or blood cultures during phototherapy
The need for blood transfusions during the study
Incidence clinical benefit of Kern icterus
Age
From 3 days old to 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ethics committee of Babol University of Medical Sciences
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
45745-47176
Approval date
2018-09-18, 1397/06/27
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.134
Health conditions studied
1
Description of health condition studied
Neonatal Hyperbilirubinemia
ICD-10 code
P59.9
ICD-10 code description
Neonatal jaundice, unspecified
Primary outcomes
1
Description
25(OH) vitamin D
Timepoint
Before phototherapy and 72 hours after the start of phototherapy
Method of measurement
ELISA - ng/ml
Secondary outcomes
1
Description
Bilirubine level
Timepoint
at admision, phototherapy, discharge time
Method of measurement
Measuring of the total serum bilirubin level by biochemistry kits manufactured in Iran and by the method of spectrophotometry.
Intervention groups
1
Description
Infants received phototherapy at a distance of 20 centimeters from the body surface.Bilirubin was cheeked by spectrophotometry method by chemical kits and serum 25(OH) vitamin D level was checked by ELISA; in two times before phototherapy and 72 hours after the start of phototherapy
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkola Children’s Hospital
Full name of responsible person
Yadollah Zahedpasha
Street address
No 19, Amirkola Children’s Hospital, Amirkola, Babol, Mazandaran Province, IR Iran.
City
Amirkola, Babol
Province
Mazandaran
Postal code
4731741151
Phone
+98 11 3234 6963
Email
y.zahedpasha@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Babol university Of medical seinces, University square , Babol
City
Babol
Province
Mazandaran
Postal code
45745-47176
Phone
+98 11 3219 9595
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Yadollah Zahedpasha
Position
Full professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No 19, Amirkola Children’s Hospital, Amirkola, Babol, Mazandaran Province, Iran
City
Babol
Province
Mazandaran
Postal code
4731741151
Phone
+98 11 3234 6963
Email
y.zahedpasha@mubabol.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Mousa Ahmadpour-Kacho
Position
Full professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No 19, Amirkola Children’s Hospital, Amirkola, Babol, Mazandaran Province, Iran
City
Babol
Province
Mazandaran
Postal code
4731741151
Phone
+98 11 3234 2151
Email
mousa_ahmadpour@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Yadollah Zahedpasha
Position
Full professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No 19, Amirkola Children’s Hospital, Amirkola, Babol, Mazandaran Province, IR Iran.
City
Babol
Province
Mazandaran
Postal code
4731741151
Phone
+98 11 3234 6963
Email
y.zahedpasha@mubabol.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD