Evaluation of the effectiveness of glycerin suppository on the prevention of neonatal jaundice
Design
Two parallel group of intervention and control that selected by random sampling and they were single-blinded in investigation of results.
Settings and conduct
Investigation was done in sanandaj besat hospital. In this hospital all neonates divided into two groups. Intervention group pushed by glycerin suppository 30 minutes after birth and repeated it after 12 hours again and 12,24,48 hours after birth billirubin range checked by bilicheck (ictrometer) and 5 days after birth called neonate's parents for their neonates follow up by checking billirubin range by bilicheck.
Control group was not intervened with any suppository just checked their bilirubin range 12, 24, 48 hours after birth and also repeated their follow up 5 days after birth. Then all of the data for example first meconium defecation time, total bilirubin range collected by researcher.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
All of the neonates with gestational age between 37-42 weeks that born with NVD delivery
Exclusion criteria:
All of pathologic causes that make jaundice excluded from this study
Weight under 2500g
Born before 37week of gestational age
Coombs positive
Mismatch blood group
Puerperal fever
GDM
Cephalohematoma
Addicted mother
Cesarian section type delivery
Intervention groups
Intervention group: all of the newborn neonates of besat hospital intervened by pushing the glycerin suppository in the neonates anal canal
Control group: all of the new born neonates without any intervention just evaluated by billirubin range
Main outcome variables
bilirubin range
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180306038980N1
Registration date:2019-01-16, 1397/10/26
Registration timing:retrospective
Last update:2019-01-16, 1397/10/26
Update count:0
Registration date
2019-01-16, 1397/10/26
Registrant information
Name
Rahmetulla Iri
Name of organization / entity
Kurdistan university of medicl sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 3217 8113
Email address
dr.iri76@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
2017-07-02, 1396/04/11
Actual recruitment end date
2017-12-22, 1396/10/01
Trial completion date
2017-12-22, 1396/10/01
Scientific title
Study of the effectiveness of glycerin suppository on prevention of neonatal jundice in neonatal
Public title
Evaluation of Effect of glycerin suppository in prevention of neonatal jaundice in besat hospital in sanandaj in 2016-17
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
all of the newborn of besat hospital of sanandaj and referred newborn to that hospital
Exclusion criteria:
under 2500 gr weight
birth before 37th week of pregnancy
positive combs
ABO
FEVER
Fever
GDM
Cephalohematoma
addicted mother
c/s
Age
From 1 day old to 1 day old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
220
Actual sample size reached:
210
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 kurdistan university of medical sciences
Street address
pasdaran bvl.
City
sanandaj
Province
Golestan
Postal code
66177.13446
Approval date
2017-03-06, 1395/12/16
Ethics committee reference number
IR.MUK.REC.1395/387
Health conditions studied
1
Description of health condition studied
neonatal jundice
ICD-10 code
P59
ICD-10 code description
Neonatal jaundice from other and unspecified causes
Primary outcomes
1
Description
Billirubin range
Timepoint
12,24 and 48 hours and 5 day after birth
Method of measurement
bilicheck instrument
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: all of the newbirth neonates intervened by pushing turur anal canal by 1mg pediatrics glycerin suppository made by iran-najo factory at the birth time,12be and 24nd after birth and checked their bilirubin by Bolshevik 12,24,48be and 5 day after birth.
Category
Prevention
2
Description
Control group: All of the newbirth neonates that they didn't push by glycerin suppository and but checked their bilirubin range by billicheck 12,24,48 hours and 5 day after birth.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
besat hospital of sanandaj
Full name of responsible person
rahmetulla iri
Street address
Besat hospital, Keshavarz ave. , Azadi square
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3328 5910
Email
besathospital@muk.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
dr.farzin rezaei
Street address
pasdaran bvl. sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 1666 4653
Email
info@muk.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?