Sore nipples are one of the most common causes of unsuccessfully breast feeding during the first few days. There are many treatments with different therapeutic effects for sore nipples. The local wage of breast milk for sore nipple treatment is used in many cultures. This is a randomized clinical trial to compare the effect of rubbing breast milk versus lanolin in the treatment of sore nipples in NICU of Emamreza hospital. We randomly divide the patients into 3 groups (breast milk, lanolin, and control). They are visited at third, fifth, seventh and 10th days to monitor the improvement and wound healing and drug side effects. In the first group at end of the each breast feeding, the hind milk is rubbed into the nipple and during the breast will dressed. Lanolin users rubb lanolin into their nipples 3 times a day. The control group is just observed. Then data will analyzed by using spss.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138711061162N11
Registration date:2009-06-07, 1388/03/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-06-07, 1388/03/17
Registrant information
Name
Ashraf Mohammadzadeh
Name of organization / entity
Neonatal Research Center of Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1852 1121
Email address
mohamadzadeha@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of medical sciences
Expected recruitment start date
2004-07-15, 1383/04/25
Expected recruitment end date
2006-07-15, 1385/04/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of breast milk and lanolin on sore nipple
Public title
The effect of breast milk and lanolin on sore nipple
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All mothers who their neonates are admitted in NICU of Emamreza hospital and have nipple sore and give milk to baby by breast milk. Exclusion criteria: Abscess and infection in breast that is contraindicated for breast feeding.
Age
From 17 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
225
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice chancellor for research of Mashhad University of medical sciences
Street address
Ghoreshi building, Daneshgah street
City
Mashhad
Postal code
13131-91379
Approval date
2004-07-07, 1383/04/17
Ethics committee reference number
5/1813
Health conditions studied
1
Description of health condition studied
sore nipple
ICD-10 code
N64.0
ICD-10 code description
Fissure and fistula of nipple
Primary outcomes
1
Description
Improving of wound healing.
Timepoint
third, fifth, seventh and tenth days
Method of measurement
Clinical and physical examination
Secondary outcomes
1
Description
side effect
Timepoint
daily
Method of measurement
Clinical examination and interview with mothers
Intervention groups
1
Description
Breast milk group:Rubbing of mother milk on sore nipple
Category
Treatment - Other
2
Description
control group: no intervention
Category
N/A
3
Description
lanolin group: Rubbing of lanolin on sore nipple
Category
empty
Recruitment centers
1
Recruitment center
Name of recruitment center
NICU of Emamreza hospital
Full name of responsible person
Dr.Ashraf mohammadzadeh
Street address
Neonatal research center- NICU- Emamreza hospital-mashhad-Iran
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of medical sciences
Full name of responsible person
Dr jalil tavakol afshari
Street address
Ghoreshi bulding-daneshgah street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of medical sciences
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
Neonatal Research Center
Full name of responsible person
Dr. Ashraf mohammadzadeh
Position
Neonatologist, professor
Other areas of specialty/work
Street address
NRC-NICU-Emamreza hospital
City
Mashhad
Postal code
9137913316
Phone
+98 51 1852 1121
Fax
+98 51 1852 5316
Email
mohamadzadeha@mums.ac.ir
Web page address
www.mums.ac.ir/nrc
Person responsible for scientific inquiries
Contact
Name of organization / entity
Neonatal Research Center
Full name of responsible person
Dr.Ashraf mohammadzadeh
Position
Neonatologist, professor
Other areas of specialty/work
Street address
NRC-NICU-Emaereza hospital
City
Mashhad
Postal code
9137913316
Phone
+98 51 1852 1121
Fax
+98 51 1852 5316
Email
mohamadzadeha@mums.ac.ir
Web page address
www.mums.ac.ir/nrc
Person responsible for updating data
Contact
Name of organization / entity
Neonatal Research Center
Full name of responsible person
Dr.Ashraf mohammadzadeh
Position
Neonatologist, professor
Other areas of specialty/work
Street address
NRC-NICU-Emaereza hospital
City
Mashhad
Postal code
9137913316
Phone
+98 51 1852 1121
Fax
+98 51 1852 5316
Email
mohamadzadeha@mums.ac.ir
Web page address
www.mums.ac.ir/nrc
Sharing plan
Deidentified Individual Participant Data Set (IPD)