Comparing the effect of breast milk topical application, 96% ethyl alcohol and natural dry care on the timing of umbilical cord separation in healthy and term newborns.
Comparing the effect of breast milk topical application, 96% ethyl alcohol and natural dry care on the timing of umbilical cord separation in healthy and term newborns.
The aim of this study is to compare the effect of breast milk topical application, 96% ethyl alcohol, and natural dry care on the timing of umbilical cord separation in healthy and term newborns. In this randomized study 207 neonates (69 neonates in each group) will be studied. Right after birth newborns will be allocated randomly to one of the three groups: breast milk topical application (case group) , 96% ethyl alcohol topical application (case group) and natural drying keep the umbilical cord (control group). In brest milk topical application group, mother's own milk, and in ethyl alcohol group, 96% ethyl alcohol from three hours after birth every 12 hours to 2 days after the umbilical cord separation will be rubbed to umbilical cord remaining part and it's cutted edge.
In the group of natural dry care of the umbilical cord, we will recommend to mother not to use anything on the umbilical cord. The researcher will ask exact date and time of umbilical cord separation from mother through telephone .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013042813157N1
Registration date:2013-11-11, 1392/08/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-11-11, 1392/08/20
Registrant information
Name
Khadijeh Ghoreishi
Name of organization / entity
Hamedan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
00988118380436, 00988118380573
Email address
besat@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2013-02-14, 1391/11/26
Expected recruitment end date
2013-06-16, 1392/03/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of breast milk topical application, 96% ethyl alcohol and natural dry care on the timing of umbilical cord separation in healthy and term newborns.
Public title
The effect of breast milk, alcohol and natural dry care on the timing of umbilical cord separation.
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: healthy and term newborns with gestational age with 37-42 weeks.
Exclusion criteria: newborns with any congenital disorder or disease, newborns with respiratory distress, perinatal asphyxia, newborns with urgent need to evaluation and treatment, metabolic disease, and any other problem which has immediate need to transfer to neonatal intensive care unit.
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
207
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
Ethics committee of Hamedan University of Medical Science
Street address
Shahid Fahmideh Blvd, Front Mardom Park, Hamedan University of Medical Science, Hamedan
City
Hamedan
Postal code
65178
Approval date
2013-02-14, 1391/11/26
Ethics committee reference number
4023/9/35/16/پ
Health conditions studied
1
Description of health condition studied
Umbilical cord care
ICD-10 code
P96.9
ICD-10 code description
Condition originating in the perinatal period, unspecified
Primary outcomes
1
Description
Umbilical cord separation time
Timepoint
From birth to umbilical cord separation time
Method of measurement
Observation in hours
Secondary outcomes
1
Description
Bleeding continuation after umbilical cord separation.
Timepoint
After umbilical cord separation
Method of measurement
Observation
Intervention groups
1
Description
Intervention group1: In breast milk topical application group we will ask all mothers to rub their milk to umbilical cord stump every 12 hours (2 times a day) from three hours after birth until 2 days after the umbilical cord separation after washing their hands with water and soap.
Category
Other
2
Description
Intervention group2: In 96% ethyl alcohol topical application group we will ask all mothers to moisten a cotton swab by placing it on the mouth of the ethyl alcohol bottle, then gently rub it completely on the skin of abdomen around and stump of umbilical cord every 12 hours (2 times a day) from three hours after birth until 2 days after the umbilical cord separation .
Category
Other
3
Description
Control group: In natural dry care group we will ask mothers not to use anything on umbilical cord stump
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital of Hamedan
Full name of responsible person
Ghoreishi Khadijeh
Street address
Pasdaran street, Shariati Square, Hamedan
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Hamedan University of Medical Science
Full name of responsible person
Godarzi Mohammad Taghi
Street address
Shahid Fahmideh Blvd, Front Mardom Park, Hamedan University of Medical Science, Hamedan
City
Hamedan
Grant name
ندارد
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Hamedan University of Medical Science
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
Besat Hospital of Hamedan
Full name of responsible person
Ghoreishi Khadijeh
Position
General Physician
Other areas of specialty/work
Street address
Ayatollah Motahari Blvd, Resalat Square, Hamedan
City
Hamedan
Postal code
6514845471
Phone
+98 811264002051
Fax
+98 81 1265 1515
Email
Qoreishi372@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Besat Hospital of Hamedan
Full name of responsible person
Eghbalian Fatemeh
Position
Faculty Member
Other areas of specialty/work
Street address
Ayatollah Motahari Blvd, Resalat Square, Hamedan
City
Hamedan
Postal code
6514845471
Phone
+98 811264002051
Fax
+98 81 1265 1515
Email
Besat@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Besat Hospital of Hamedan
Full name of responsible person
Ghoreishi Khadijeh
Position
General physician
Other areas of specialty/work
Street address
Ayatollah Motahari Blvd, Resalat Square, Hamedan
City
Hamedan
Postal code
6514845471
Phone
+98 811264002051
Fax
+98 81 1265 1515
Email
Qoreishi372@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)