A clinical trial on 140 infants (70 patients in each group) suffering from diaper dermatitis that referred to Amir Kabir hospital. This study compared the effect of breast feeding and use of topical hydrocortisone ointment 1% for healing diaper dermatitis in infants. Initially selected based on Form Action Research Unit eligible to be selected. Research Selection criteria included Infants under 24 months, there is no known diseases that require to special treatment, no using other drugs for healing diaper dermatitis, no using antibiotics during research, there is no fungal dermatitis by exploration of physician . Then infants randomly to 2 groups, taking topical applicaton of breast milk and hydrocortizone1% . Group control ointment hydro cortisone 1% rate of two times a day after washing and changing diaper at the site of dermatitis . diaper drmatitis will evaluate by six-point scale in days 0,3 and 7 in two groups . full healing time will calculate and compare in two groups .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102163869N2
Registration date:2011-06-03, 1390/03/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-06-03, 1390/03/13
Registrant information
Name
Leila Amirifarahani
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1417 3524
Email address
l.amirifarahani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University Of Medical Sciences
Expected recruitment start date
2010-09-06, 1389/06/15
Expected recruitment end date
2011-02-04, 1389/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of topical application of breast human milk and Hydrocortisone 1% ointment on diaper dermatitis healing among infants
Public title
Comparison of topical application of breast human milk and Hydrocortisone 1% ointment on diaper dermatitis healing among infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Infants under 24 months, Exclusion criteria: there is known diseases that require to special treatment, using other drugs for healing diaper dermatitis, using antibiotics during research, there is fungal dermatitis by exploration of physician
Age
To 2 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
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
1
Registry name
Arak University Of Medical Sciences
Secondary trial Id
89-86-8
Registration date
2010-06-30, 1389/04/09
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University Of Medical Sciences
Street address
Arak University Of Medical Sciences, Sardasht, Arak
City
Arak
Postal code
Approval date
2010-06-30, 1389/04/09
Ethics committee reference number
89-86-8
Health conditions studied
1
Description of health condition studied
Diaper dermatitis
ICD-10 code
L22
ICD-10 code description
Diaper [napkin] dermatitis
Primary outcomes
1
Description
severity of diaper dermatitis
Timepoint
before teratment,days of 3 and 7 after treatment
Method of measurement
6-point scale for severity of diaper dermatitis
Secondary outcomes
1
Description
healing time for diaper dermatitis
Timepoint
healing time for diaper dermatitis
Method of measurement
6-point scale for severity of diaper dermatitis
Intervention groups
1
Description
group1: using topical application of hind milk after diaper change
Category
Treatment - Drugs
2
Description
group2: using topical application of Hydrocortizone 1%
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Kabir Hospital in Arak
Full name of responsible person
Street address
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University Of Medical Sciences
Full name of responsible person
Leila Amiri Farahani
Street address
Arak University Of Medical Sciences, Sardasht, Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University Of Medical Sciences
Full name of responsible person
leila Amiri Farahani
Position
member of faculty in midwifery group
Other areas of specialty/work
Street address
Arak University Of Medical Sciences, Sardasht, Arak
City
Arak
Postal code
Phone
+98 86141735025
Fax
Email
l.amirifarahani@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University Of Medical Sciences
Full name of responsible person
Leila Amiri Farahani
Position
MSc of Midwifery
Other areas of specialty/work
Street address
Arak University Of Medical Sciences, Sardasht, Arak
City
Arak
Postal code
Phone
+98 86141735025
Fax
Email
l.amirifarahani@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University Of Medical Sciences
Full name of responsible person
Leila Amiri Farahani
Position
MSc of midwifery
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)