Objective
Such complications of phototherapy include seizure, apnea and lethargy is noxious.This study designed to evaluate of head and head covering during phototherapy in prevention of this complications
Design
This study is a prospective randomized clinical trial which was conducted on premature infants with gestational age less than 35 weeks since March 2014 to March 2015.In this study 86 preterm infants divided into two groups (n = 43)
Setting and conduct
In both intervention and control group underwent phototherapy using 4 fluorescent lamps in the blue color in distance of 35 cm. Eyes and genitalia were protected. Over the head and head was covered using cloth helmet with a suitable size only in intervention group. Total serum calcium was measured before and 36 hours after Phototherapy in both group.Total calcium below 8 mg/dL was considered as hypocalcemia in both groups
Inclusion and Exclusion criteria
Inclusion criteria: preterm infants with gestational age less than 35 weeks with Jaundice who needed phototherapy; lack of congenital malformations at birth; the infant's mother did not suffer from gestational diabetes or hyperparathyroidism; the infant's mother did not take anticonvulsive drugs during pregnancy; lack of prenatal asphyxia (Apgar score 5 minutes, 0 to 3 and bicarbonate ph birth less than 7 and umbilical cord less than 12); the infant was not treated with sodium bicarbonate; the baby with no exchange transfusion , IUGR and sepsis.
Exclusion criteria: Affection of neonatal sepsis; administration of sodium bicarbonate; exchange transfusion
Intervention
Head covering during phototherapy
Main outcome measures
Calcium measurment
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015042321910N1
Registration date:2015-12-30, 1394/10/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-30, 1394/10/09
Registrant information
Name
Behzad Barekatain
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3261 6670
Email address
b_barekatain@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Isfahan University of Medical Sciense
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2015-03-21, 1394/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of head covering in prevention of phototherapy induced hypocalcaemia in icterus newborns with gestational age Less than 35 weeks
Public title
The effect of head covering in prevention of Phototherapy induced hypocalcaemia in icterus newborns with gestational age Less than 35 weeks
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: preterm infants with gestational age less than 35 weeks with Jaundice who needed phototherapy; lack of congenital malformations at birth; the infant's mother did not suffer from gestational diabetes or hyperparathyroidism; the infant's mother did not take anticonvulsive drugs during pregnancy; lack of prenatal asphyxia (Apgar score 5 minutes, 0 to 3 and bicarbonate ph birth less than 7 and umbilical cord less than 12); the infant was not treated with sodium bicarbonate; the baby with no exchange transfusion , IUGR and sepsis.
Exclusion criteria:Affection of neonatal sepsis,administration of sodium bicarbonate,exchange transfusion
Age
To 1 month old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
----------
Secondary trial Id
----------
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciense
Street address
Hezarjerib bolvar, Isfahan University of Medical Sciense
City
Isfahan
Postal code
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
393915
Health conditions studied
1
Description of health condition studied
Neonatal Jaundice
ICD-10 code
P59.9
ICD-10 code description
Neonatal jaundice, unspecified
2
Description of health condition studied
Neonatal hypocalcemia
ICD-10 code
P71.1
ICD-10 code description
Other neonatal hypocalcaemia
Primary outcomes
1
Description
serum calcium
Timepoint
before and 36 hourse after phototherapy
Method of measurement
Mesurement of serum calcium
Secondary outcomes
1
Description
Jitteriness
Timepoint
During study
Method of measurement
Observation and Physical examination
2
Description
Siezure
Timepoint
During study
Method of measurement
Observation and Physical examination
3
Description
Apnea
Timepoint
During study
Method of measurement
Observation and Physical examination
Intervention groups
1
Description
Intervention group: Head covering during phototherapy for prevention of hypocalcemia
Category
Prevention
2
Description
Control group: Phototherapy without head covering
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
shahid beheshti hospitals
Full name of responsible person
Behzad Barekatain
Street address
Isfahan, Felezi Bridge
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Isfahan University of Medical Sciense
Full name of responsible person
Mehdi Nematbakhsh
Street address
Hezarjerib bolvar, Isfahan University of Medical Sciense
City
Isfahan
Grant name
-------
Grant code / Reference number
--------
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Isfahan University of Medical Sciense
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
Isfahan University of Medical Sciense
Full name of responsible person
Neda Hosseini
Position
Resident of Pediatrics
Other areas of specialty/work
Street address
Department of pediatrics, Isfahan University of Medical Sciense
City
Isfahan
Postal code
Phone
+98 31 3386 8247
Fax
Email
neda.8892@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Scienses
Full name of responsible person
Behzad Barekatain
Position
Academic member of Isfahan University of Medical Scienses, Neonatologist
Other areas of specialty/work
Street address
Nom 302, Arian apartment building, Mehran ave, Moshtagh st, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3261 6670
Fax
Email
b_barekatain@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Scienses
Full name of responsible person
Behzad Barekatain
Position
Academic member of Isfahan University of Medical Scienses, Neonatologist
Other areas of specialty/work
Street address
Nom 302, Arian apartment building, Mehran ave, Moshtagh st, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3261 6670
Fax
Email
b_barekatain@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)