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The study of the effect of breast milk,sugar solution,local anesthesia and Kangaroo mother care (KMC) to heel puncture in pain relief in full term neonates in Marvdasht Motahari hospital(1394)

Protocol summary

Summary
Goal: Study of breast milk, local anesthasia, Dextrose Water 25 % and Kangaroo Mother Care (KMC) in pain management to heel puncture of full term neonates in Marvdasht Shahid Motahari Hospital. Inclusion Criteria: 3-5 days normal fullterm neonate except jaundice. Exclusion Criteria: Formula Milk, NPO, Gestational Diabetic of Mother (GDM) Sampling Size:160 Interventions: Breast milk 15 min before procedure; Kangaroo Mother Care (KMC) 15 min before procedure; Using 2 ml Dextrose Water 25 %, 15min before procedure and local anesthesia (EMLA cream) 15 min bofore procedure. Primary Outcome Measure: Baseline Pain Management.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015120125326N1
Registration date: 2016-01-24, 1394/11/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-01-24, 1394/11/04
Registrant information
Name
Soroush Soltani
Name of organization / entity
Shiraz university of medical sience-International branch
Country
Iran (Islamic Republic of)
Phone
+98 72 8334 5705
Email address
soltaniso@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Science/International Branch
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-01-21, 1394/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of the effect of breast milk,sugar solution,local anesthesia and Kangaroo mother care (KMC) to heel puncture in pain relief in full term neonates in Marvdasht Motahari hospital(1394)
Public title
pain management in neonates
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion:Full term neonates. Exclusion:GDM;Infant formula;NPO
Age
From 3 days old to 5 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sience, International Branch
Street address
Number 71, Alley 1, Jahad Sazandegi Street, Azadi Square, Shiraz
City
Shiraz
Postal code
7144716699
Approval date
2015-12-13, 1394/09/22
Ethics committee reference number
IR.SUMS.REC.1394.156

Health conditions studied

1

Description of health condition studied
pain management in neonates
ICD-10 code
P59.9
ICD-10 code description
Neonatal jaundice, unspecified

Primary outcomes

1

Description
pain
Timepoint
Baseline
Method of measurement
NIPS

Secondary outcomes

1

Description
Age,Gender
Timepoint
Baseline
Method of measurement
NIPS

Intervention groups

1

Description
Using local anesthesia (EMLA cream) 15 min before procedure
Category
Treatment - Drugs

2

Description
Breast milk 15 min before procedure
Category
Prevention

3

Description
Kangaroo Mother Care 15 min before procedure
Category
Treatment - Drugs

4

Description
Using 2 cc Dextrose Water 25%,15 min before procedure
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Motahari Hospital
Full name of responsible person
Medical doctor, Soroush Soltani, Intern
Street address
Marvdasht Shahid Motahari Hospital, Shiraz, Fars, Iran
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Doctor Dariyoosh Zohoori
Street address
Marvdasht Shahid Motahari Hospital
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Soroush Soltani
Street address
Marvdasht Shahid Motahari Hospital
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
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 Sience,International Branch
Full name of responsible person
Soroush Soltani
Position
Medical doctor, Intern
Other areas of specialty/work
Street address
Number 71, Alley 1, Jahad Sazandegi Street, Azadi Square, Shiraz
City
Shiraz
Postal code
7144716699
Phone
+98 71 3227 4250
Fax
+98 71 3227 4250
Email
dzohoori@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sience, International Branch
Full name of responsible person
Soroush Soltani
Position
Medical doctor, Intern
Other areas of specialty/work
Street address
Number 71, Alley 1, Jahad Sazandegi Street, Azadi Square, Shiraz
City
Shiraz
Postal code
7144716699
Phone
+98 71 3227 4250
Fax
+98 71 3227 4250
Email
dzohoori@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sience, International Branch
Full name of responsible person
Soroush Soltani
Position
Medical doctor،intern
Other areas of specialty/work
Street address
Number 71, Alley 1, Jahad Sazandegi Street, Azadi Square, Shiraz
City
Shiraz
Postal code
7144716699
Phone
+98 71 3227 4250
Fax
+98 71 3227 4250
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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