Head covering during phototherapy appropriate and safe method for Prevention of phototherapy-induced hypocalcaemia in icterus newborn with unaltered serum magnesium level.
Objectives: The aim of the present investigation was to study the effect of hat on calcium and magnesium levels in full term newborns during phototherapy.
Design: In this randomized clinical trial, 72 icterus newborns with indirect hyperbillirubinemia who received phototherapy in phototherapy ward of Moslemin Hospital in Shiraz province of Iran from March to September 2010 were studied randomly in two groups.
Setting and Conduct: Phototherapy was conducted in the control group, while was performed with hat for the test group.
Participants including major eligibility criteria: They were full term and weighted more than 2500 gr. Apart from icterus; indirect bilirubin between 13 to 18 mg/dl in full term neonates - their physical status was completely normal. The newborns were in perfect health during the tests. Newborns with asphyxia; respiratory distress; sepsis; hemolytic anemia; infants of mothers with diabetic or thyroid disorders was excluded from study.
Intervention: The calcium and magnesium levels of each newborn were tested on arrival, 48 hours after phototherapy, and 24 hours following phototherapy.
Main outcome measure variables: Billirubin, calcium and Magnesium
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013102315134N1
Registration date:2014-01-08, 1392/10/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-01-08, 1392/10/18
Registrant information
Name
Zahra Jamshidi
Name of organization / entity
Shiraz Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1636 4001
Email address
jamshidiz@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy chancellor for research of Shiraz University of Medical Sciences
Expected recruitment start date
2010-03-20, 1388/12/29
Expected recruitment end date
2011-03-20, 1389/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Head covering during phototherapy appropriate and safe method for Prevention of phototherapy-induced hypocalcaemia in icterus newborn with unaltered serum magnesium level.
Public title
Head covering effects on serm calcium during phototherapy
Purpose
Prevention
Inclusion/Exclusion criteria
The major including criteria were : Full term;
Weighed more than 2500 grams; Had normal serum calcium; Apart from icterus; indirect bilirubin between13 to 18 mg/dl in full term neonates - their physical status was completely normal.
The major excluding criteria were: Asphyxia; respiratory distress; sepsis; hemolytic anemia; infants of mothers with diabetic or thyroid disorders.
Age
From 3 years old to 5 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
72
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
Ethics committee of Shiraz University of Medical Sciences
Street address
7 floor, Shiraz University of Medical Sciences building, Zand street
City
Shiraz
Postal code
73452-46372
Approval date
2010-11-21, 1389/08/30
Ethics committee reference number
89-5313
Health conditions studied
1
Description of health condition studied
Jaundice
ICD-10 code
p50 , p51
ICD-10 code description
Haemorrhagic and haematological disorders of fetus and newborn
Primary outcomes
1
Description
Bilirubin
Timepoint
The bilirubin level of each newborn were tested on arrival, 48 hours after phototherapy, and 24 hours following phototherapy.
Method of measurement
Blood sample
2
Description
Calcium
Timepoint
The calcium level of each newborn were tested on arrival, 48 hours after phototherapy, and 24 hours following phototherapy.
Method of measurement
Blood sample
3
Description
Magnesium
Timepoint
The calcium level of each newborn were tested on arrival, 48 hours after phototherapy, and 24 hours following phototherapy.
Method of measurement
Blood sample
Secondary outcomes
empty
Intervention groups
1
Description
Case group intervention: The occipital area of this group during phototherapy was covered by a hat. Calcium and magnesium levels were checked at the beginning, 48 hours after starting phototherapy, and 24 hours after the treatment. All the infants were placed under phototherapy with 8 Lamp, 40 watts, blue light with a wavelength of 470-410 nanometers, at a distance of 40 -30 cm from the body surface area. Calcium level equal to or less than 7.5 mg/dl was considered as hypocalcaemia and Mg level equal to or less than 1.2 mg/dl was considered as hypomagnesaemia. White cabling Hat was used for newborns.
Category
Prevention
2
Description
Control group intervention: Routine phototherapy was used for first group. Calcium and magnesium levels were checked at the beginning, 48 hours after starting phototherapy, and 24 hours after the treatment. All the infants were placed under phototherapy with 8 Lamp, 40 watts, blue light with a wavelength of 470-410 nanometers, at a distance of 40-30 cm from the body surface area.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Moslemin Hospital
Full name of responsible person
Shahla Yousefi
Street address
Khayam street, Zand BLVD, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for reasearch , Shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Hatam
Street address
Vice chancellor for reasearch office, Shiraz University of Medical Sciences building, Zand BLVD
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for reasearch , Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Marzieh Kargar
Position
Msc of Pediatric Nursing
Other areas of specialty/work
Street address
Zand Street, Fatemeh Nursing and Midwifery College
City
Shiraz
Postal code
71936-13119
Phone
+98 71 1647 4252
Fax
+98 71 1647 4252
Email
kargarm@sums.ac.ir
Web page address
nurs-midwif.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Marzieh Kargar
Position
Msc of Pediatric Nursing
Other areas of specialty/work
Street address
Zand Street, Fatemeh (PBUH) Nursing and Midwifery College
City
Shiraz
Postal code
71936-13119
Phone
+98 71 1647 4252
Fax
+98 71 1647 4252
Email
kargarm@sums.ac.ir
Web page address
nurs-midwif.sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Jamshidi
Position
Msc of Pediatric Nursing
Other areas of specialty/work
Street address
Ghadamgah Street
City
Shiraz
Postal code
71748-34459
Phone
+98 71 1821 6171
Fax
-
Email
jamshidiz@sums.ac.ir
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)