Evaluation of the efficacy of oral agar gel administration on prevention of non hemolytic jaundice in normal term neonates; a double blind controlled trial
In this study that will be done in Kerman medical university, neonatal ICU, we will assess the effect of oral agar gel in the prevention of non hemolytic jaundice in healthy and term neonates. In the first 24 hours of birth, bilirubin of 50 term neonates who their birth weight are more than 2500 grams and have no signs of infections or hemolytic disease is controlled with JM103 device in the form of transcutaneous measuring. Then, with regard to hyperbilirubinemia curve, those neonates who are in the risk of average or high hyperbilirubinemia are randomly divided into 2 groups of agar and placebo to receive either 500 mg of soluble agar in 2/5 cc aquapura or only aquapura every 6 hours. In the third and fifth day of birth, bilirubin is controlled in this way. In some cases that bilirubin is above physiologic range (13 mg/dl) bilirubin levels are checked by heel blood sampling too.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811133250N1
Registration date:2010-04-24, 1389/02/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-04-24, 1389/02/04
Registrant information
Name
Bahareh Bahman Bijari
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1322 2250
Email address
bbbijari@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Science
Expected recruitment start date
2009-12-22, 1388/10/01
Expected recruitment end date
2010-04-21, 1389/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of oral agar gel administration on prevention of non hemolytic jaundice in normal term neonates; a double blind controlled trial
Public title
Evaluation of the efficacy of oral agar gel administration on prevention of non hemolytic jaundice in normal term neonates; a double blind controlled trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: healthy, term infant with birth weight more than 2500 grams
Exclusion criteria: Infants with infection, ABO or Rh incompatibility, G6PD deficiency and signs of lethargy or poor feeding
Age
To 1 year old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kerman University of Medical Sciences and Health Services
Street address
Jomhoori Blvd.
City
Kerman
Postal code
Approval date
2010-02-08, 1388/11/19
Ethics committee reference number
K/88/232
Health conditions studied
1
Description of health condition studied
Neonatal jaundice
ICD-10 code
P59.9
ICD-10 code description
Neonatal jaundice, unspecified
Primary outcomes
1
Description
Serum bilirubin level
Timepoint
First day of life, third and 5th days of life after intervention
Method of measurement
JM103- skin jaundicometer
Secondary outcomes
empty
Intervention groups
1
Description
Oral prescription of solution of 500 miligram of oral agar gel in 2.5 mililiter aquapura every 6 hours for 3 days
Category
Prevention
2
Description
Oral prescription of 2.5 mililiter of aquapura every 6 hours for 3 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour hospital
Full name of responsible person
Leyla Razi
Street address
Afzalipour hospital, Imam Khomeini BLV
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Science
Full name of responsible person
Bahare Bahman Bijari
Street address
Kerman University of Medical Science
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Science
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences and Health Services
Full name of responsible person
Bahareh Bahman Bijari
Position
Neonatologist
Other areas of specialty/work
Street address
Afzalipour hospital
City
Kerman
Postal code
Phone
+98 34 1245 7036
Fax
Email
bbbijari@kmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences and Health Services
Full name of responsible person
Bahareh Bahman Bijari
Position
Neonatologist-Assistant professor of Pediatrics
Other areas of specialty/work
Street address
Aafzalipour hospital
City
Kerman
Postal code
Phone
+98 34 1245 7036
Fax
Email
bbbijari@kmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)