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Comparison of the effect of topical application of human milk ,chlorhexidin and dry cord care on the cord-separation time and bacterial colonization of cord of newborn

Protocol summary

Summary
The aim of this study is to compare the impact of three regimens of cord care, topical use of human milk, chlorhexidin solution and dried cord care on the cord-separation time and occurrence of bacterial colonization among neonates. A total of 261 neonates (87 neonates in each group) will be enrolled in this randomized clinical trial. Neonates with gestational age of 42-37 weeks, which no immediate need of evaluation and treatment of the newborn, will be examined. The infants will be randomly assigned into three groups of cord care regimens: topical application of human milk (case group), topical chlorhexidine solution (case group) and dried cord care (control group). In group topical application of human milk, all mothers will be rubbed its own milk, and In group chlorhexidine, chlorhexidine solution 4% with a cotton swab on the abdominal skin around the base and cord stump thoroughly from three hours after birth every 12 hours to 2 days after the umbilical cord separation .In group dried cord, mother are recommended that don't used any material on cord. In order to make sure of the presence of the microorganisms, samples of the cord stump will be collected using sterile swabs within the first three hours after birth and other visits (days 3, 7 and 2 days after umbilical cord separation).. Researchers asked the exact date and time of the cord separation via telephone and in cases of delay in cord separation or any cord related adverse events, the newborn will be immediately visited by neonatologist.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201010285038N1
Registration date: 2012-10-25, 1391/08/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-10-25, 1391/08/04
Registrant information
Name
Fatemeh Abbaszadeh
Name of organization / entity
kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3630
Email address
abbaszadeh_f@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
the Research Deputy of Kashan University of Medical Sciences
Expected recruitment start date
2010-12-14, 1389/09/23
Expected recruitment end date
2011-12-29, 1390/10/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of topical application of human milk ,chlorhexidin and dry cord care on the cord-separation time and bacterial colonization of cord of newborn
Public title
The effect of topical application of human milk ,chlorhexidinon on umbilical cord of newborn
Purpose
Prevention
Inclusion/Exclusion criteria
Criteria for Inclusion: Newborns with gestational age 42-37 weeks; Apgar score higher than 7 at minute 1; rupture of membranes for no longer than 12 hours; The cord cut in sterile condition in the delivery room and don't use antiseptic agent on the stump. criteria for excluded: Infants with perinatal asphyxia, respiratory distress, metabolic disease, and any other problems that requiring immediate refer to neonatal Intensive Care Unit ; Infants with immediate need of evaluation and treatment; Newborns with any congenital disorder or disease; Infants of mothers with postpartum fever, mastitis, Urogenital infection; If the mother does not live in the city of Kashan(live in Rural); If the mother is the Afghani.
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 261
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Deputy of kashan University of Medical Sciences
Street address
5th of Qotb –e Ravandi Blvd. P.O.Box: 87155.154, Kashan, IRAN
City
kashan
Postal code
88141/87159
Approval date
2010-09-14, 1389/06/23
Ethics committee reference number
1781/1/5/29/پ

Health conditions studied

1

Description of health condition studied
Certain conditions originating in the perinatal period
ICD-10 code
P38
ICD-10 code description
Omphalitis of newborn with or without mild haemorrhage

Primary outcomes

1

Description
umbilical cord separation time
Timepoint
from birth to Cord separation time
Method of measurement
Researcher observed

2

Description
infection Umbilical cord
Timepoint
the first three hours after birth , days 3 and 7 after intervention ,2 days after umbilical cord separation
Method of measurement
Culture of samples

Secondary outcomes

1

Description
Complications and problems such as leakage of blood, discharge and granuloma tissue
Timepoint
the first three hours after birth , days 3 and 7 after intervention ,2 days after umbilical cord separation
Method of measurement
Observed by the researcher and visited by neonatologist if there is any cord related adverse events

Intervention groups

1

Description
Intervention GROUP:In group topical application of human milk of all mothers will be advised after washing hands with soap and water, she will rub its own milk to cord stump from three hours after birth every 12 hours (2 times a day) to 2 days after the umbilical cord separation and allow the milk of the cord is completely dry
Category
Other

2

Description
Intervention GROUP:In group chlorhexidine mother will wet a cotton swab by placing it on the mouth of the chlorhexidine bottle 4% (30 ml bottle) and inverting the bottle. Then gently will rub the abdominal skin around the base and cord stump thoroughly, ensuring that the entire area was covered with solution. A second cotton swab will similarly moistened and used to cleanse the tip of the cord (if not yet separated) or the middle of the cord stump (if separation had occurred). she will rub its from three hours after birth every 12 hours (2 times a day) to 2 days after the umbilical cord separation
Category
Other

3

Description
In group dry cord(control group ), mother will recommend that is not used any material on cord
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shabikhani Hospital of Kashan-Behesht Hospitals of Kashan
Full name of responsible person
Abbaszadeh Fatemeh
Street address
City
kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholam Ali Hamidi
Street address
Department of Physiology & Pharmacology, Kashan University of Medical Sciences, Kashan, Iran
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
kashan University of Medical Sciences
Full name of responsible person
Fatemeh Abbaszadeh
Position
msc-Faculty member
Other areas of specialty/work
Street address
5th of Qotb –e Ravandi Blvd. P.O.Box: 87155.154, Kashan, IRAN
City
kashan
Postal code
Phone
+98 36 1555 0021
Fax
Email
abbaszadehs@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
kashan University of Medical Sciences
Full name of responsible person
Fatemeh Abbaszadeh
Position
msc-Faculty member
Other areas of specialty/work
Street address
5th of Qotb –e Ravandi Blvd. P.O.Box: 87155.154, Kashan, IRAN
City
kashan
Postal code
Phone
+98 36 1555 0021
Fax
Email
abbaszadehs@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
kashan University of Medical Sciences
Full name of responsible person
Fatemeh Abbaszadeh
Position
msc-Faculty member
Other areas of specialty/work
Street address
5th of Qotb –e Ravandi Blvd. P.O.Box: 87155.154, Kashan, IRAN
City
kashan
Postal code
Phone
00
Fax
Email
abbaszadehs@yahoo.com
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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