Protocol summary

Summary
The purpose of this study was comparing the effect of topical application of breast milk and dry cord care on bacterial colonization and cord separation time in neonates. In a longitudinal study, 118 newborn neonates were investigated at Omolbanin Hospital in Mashhad, Iran. We assigned them into two groups (case and control) randomly. In case group, breast milk was used on cord 3 hours after birth and then every 12 hours until 2 days after cord separation. In control group, no substance was used and cord was sustained dry. Researcher obtained an umbilical swab from base of the cord three hours after birth and in the third day of life and called mother to record cord separation time. Rate of bacterial colonization and cord separation time were measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138708071162N7
Registration date: 2009-01-15, 1387/10/26
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2009-01-15, 1387/10/26
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 science
Expected recruitment start date
2007-02-08, 1385/11/19
Expected recruitment end date
2007-08-10, 1386/05/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of topical application of breast milk on bacterial colonization and umbilical cord separation time in neonates in comparison to dry cord care
Public title
The effect of topical application of breast milk on bacterial colonization and umbilical cord separation time in neonates in comparison to dry cord care
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: gestational age of 38-42 weeks, freedom from any disease or congenital anomalies. Exclusion criteria: infants with respiratory distress, perinatal asphyxia, metabolic derangement and any other problems requiring immediate evaluation and treatment, duration rupture of membrane more than 12 h, 1 and 5-min Apgar score <7, genitourinary system infection.
Age
From 1 year old to 21 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 118
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, mashhad, Iran
City
Mashhad
Postal code
13131-91379
Approval date
2007-02-03, 1385/11/14
Ethics committee reference number
10328/51

Health conditions studied

1

Description of health condition studied
bacterial colonization
ICD-10 code
B99
ICD-10 code description
Other infectious diseases

2

Description of health condition studied
umbilical cord separation time
ICD-10 code
L80-L99
ICD-10 code description
Other disorders of the skin and subcutaneous tissue

Primary outcomes

1

Description
Decreasing infection
Timepoint
3 hour after birth and 3 day after birth
Method of measurement
Umbilical swab from the base of cord

Secondary outcomes

1

Description
Decreasing umbilical cord separation time
Timepoint
Daily
Method of measurement
Report of mother for umblical cord separation

Intervention groups

1

Description
In control group, no substance was used and cord was sustained dry
Category
N/A

2

Description
In case group, breast milk was used on cord 3 hours after life and then every 12 hours until 2 days after cord separation
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Omolbanin 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 science
Full name of responsible person
Dr jalil tavakol afshari
Street address
ghoreshi bulding-daneshgah street-mashhad-Iran
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 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
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-mashhad-Iran
City
Mashhad
Postal code
9137913316
Phone
+98 51 1852 1121
Fax
+98 51 1852 5316
Email
mohamadzadeha@mums.ac.ir , mohammadzadeh_ashraf@yahoo.com
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-mashhad-Iran
City
Mashhad
Postal code
9137913316
Phone
+98 51 1852 1121
Fax
+98 51 1852 5316
Email
mohamadzadeha@mums.ac.ir , mohammadzadeh_ashraf@yahoo.com
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-mashhad-Iran
City
Mashhad
Postal code
9137913316
Phone
+98 51 1852 1121
Fax
+98 51 1852 5316
Email
mohamadzadeha@mums.ac.ir , mohammadzadeh_ashraf@yahoo.com
Web page address
www.mums.ac.ir/nrc

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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