Objectives: To determine weather expressed breast milk (EBM) is analgesic in healthy term newborns during venipuncture and comparison with formula and 50% dextrose solution.
Design: A randomized clinical trial.
Setting: Each infant received 3 treatments with EBM, formula and 50% dextrose solution during Venus blood sampling in consecutive 3 days and their responses were measured by behavioral acute pain rating scale for neonates (DAN Score)
Participation: A random Sample of 50 full term healthy neonates up t0 14 days who admitted with physiologic icter babies with any medical or congenital conditions such as non pathologic icter , sepsis, asphyxia , major congenital malformations excluded .
Main outcome measures: DAN behavioral Scale for neonatal pain were analyzed between EBM groups and central groups during venipuncture .
Intervention: Administration of 2 ml EBM, formula and DW50% before 3 consecutive blood sampling in three days
.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138808122658N1
Registration date:2011-04-06, 1390/01/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-06, 1390/01/17
Registrant information
Name
Fariba Tarhani
Name of organization / entity
Lorestan Medical University
Country
Iran (Islamic Republic of)
Phone
+98 66 1421 4909
Email address
tarhani.f@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Lorestan University of Medical Sciences
Expected recruitment start date
2009-06-22, 1388/04/01
Expected recruitment end date
2010-02-20, 1388/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of analgesic effect of Expressed breast milk (EBM) versus formula and dextrose 50%during venipuncture
Public title
comparison of analgesic effect of Expressed breast milk (EBM) versus formula and dextrose 50%during venipuncture
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: the study population included full term healthy neonate, up to 14 days of post natal age who admitted because of physiologic icter .
Exclusion criteria: where babies with any medical or congenital conditions such as non pathological icter , sepsis, asphyxia , major congenital malformations ,....
Age
From 1 year old to 14 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Lorestan University of Medical Sciences Ethics committee
Street address
5th km of Boroojerd Road
City
Khorram Abad
Postal code
Approval date
2010-11-02, 1389/08/11
Ethics committee reference number
18661/200
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
R52.9
ICD-10 code description
Pain, not elsewhere classified
Primary outcomes
1
Description
pain
Timepoint
daily during venipuncture
Method of measurement
DAN score
Secondary outcomes
1
Description
long term effects of painful exprience such as hypersensitivity to painful stimuli
Timepoint
daily during venipuncture
Method of measurement
DAN score
Intervention groups
1
Description
using of Expressed breast milk 2 cc, one dose , daily
Category
Prevention
2
Description
dextrose 50% , one dose , daily
Category
Prevention
3
Description
formula , one dose , daily
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Madani Hospital
Full name of responsible person
Fariba Tarhani MD
Street address
Shaghayegh Square khairabad Street
City
khorramabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Lorestan University of Medical Sciences Vice Chancellor for research
Full name of responsible person
Fariba Tarhani MD
Street address
5th km of Boroojerd Road, Khorram Abad, Lorestan
City
Khorram Abad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Lorestan University of Medical Sciences Vice Chancellor for research
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
Lorestan University of Medical Sciences
Full name of responsible person
Fariba Tarhani MD
Position
Assistant Professor
Other areas of specialty/work
Street address
Shaghayegh Square ,Kheirabad Street
City
Khorram Abad
Postal code
Phone
+98 66 1421 9124
Fax
+98 66 1420 0106
Email
f_tarhani44@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Friba Tarhani MD
Position
Assisstant Professor
Other areas of specialty/work
Street address
Shaghayegh square , Kheirabad street
City
Khorram Abad
Postal code
Phone
+98 66 1421 9124
Fax
+98 66 1420 0106
Email
f_tarhani44@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Shabnam Dalvand
Position
Nutritionist
Other areas of specialty/work
Street address
Shaghayegh square , Kheirabad street
City
Khorram Abad
Postal code
Phone
+98 66 1421 9124
Fax
+98 66 1420 0106
Email
shabnamdalvand@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)