Comparison of topical application of breast milk and routine procedure on umbilical cord separation time and the bacterial colonization in very Low Birth Weight (VLBW) Infants
In a randomized clinical trial on preterm infants (weighing less than 1500 grams) admitted to NICU and internal NICUs of Alzahra and Shahid Beheshti hospitals in Isfahan, the effect of topical use of breast milk on separation time of umbilical cord and bacterial colonization is investigated. The criteria for entering this study are premature neonates, weighing less than 1500 grams and criteria for exclusion from the study are congenital major anomalies, Asphyxia, hypoxia, and umbilical catheter insertion. A sample of 32 patients in each group was calculated according to the related equation.
these infants are divided into 2 groups of topical use of breast milk on umbilical cord (M) and dry care group (D).
In group (M) 3-4 drops of breast milk are applied to the umbilical cord within 8 hours of birth, and this is continued every 8 hours to two days after separation of the umbilical cord. in group (D)umbilical cord is exposed to the open air to dry gradually and does not use any substance. (Conventional routine). 3 samples of cultivated swab were taken from the umbilical cord of each infant (2-4 hours after birth, after 3 days, day of umbilical cord separation) to check for bacterial colonization. Neonates in both groups will be monitored for symptoms of omphalitis, bad smell, exudates, granulation tissue and sepsis. Then the information of each infant is recorded in the questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017052110026N8
Registration date:2017-09-19, 1396/06/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-09-19, 1396/06/28
Registrant information
Name
Amir mohammad Armanian
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1235 5059
Email address
armanian@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences, Isfahan, Iran
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of topical application of breast milk and routine procedure on umbilical cord separation time and the bacterial colonization in very Low Birth Weight (VLBW) Infants
Public title
Effect of topical application of breast milk on umbilical cord separation time in very Low Birth Weight (VLBW) Infants
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria for this study: preterm birth (pre-maturity), weighing less than 1500 grams
Exclusion criteria for this study: major congenital anomalies, presence of asphyxia and hypoxia, umbilical catheter
Age
To 1 month old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
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 Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjerib st.
City
Isfahan
Postal code
Approval date
2013-11-02, 1392/08/11
Ethics committee reference number
292143
Health conditions studied
1
Description of health condition studied
Neonatal skin infection
ICD-10 code
p39.4
ICD-10 code description
Neonatal skin infection
Primary outcomes
1
Description
day of umbilical cord separation
Timepoint
at the 3th and 7th days of life
Method of measurement
daily recorded sheets
Secondary outcomes
1
Description
bacterial colonization
Timepoint
at the 3th, 7th days of life
Method of measurement
swap- culture
2
Description
omphalitis
Timepoint
at the 3th, 7th days of life
Method of measurement
daily recorded sheets
3
Description
exudate
Timepoint
at the 3th, 7th days of life
Method of measurement
daily recorded sheets
4
Description
granulation tissue
Timepoint
at the 3th, 7th days of life
Method of measurement
daily recorded sheets
5
Description
sepsis
Timepoint
at the 3th, 7th and 15th days of life
Method of measurement
daily recorded sheets
Intervention groups
1
Description
In the control group (dry care), the umbilical cord is allowed to dry in open air gradually. Then, within 2-4 hours after birth, a culture swab from the umbilical stump is sent to laboratory as baseline. Then, two other culture swabs from the umbilical stump, one at 3 days after birth and the other on the day that the umbilical cord was removed is sent to check bacterial colonization.
Category
Prevention
2
Description
In the intervention group (breast milk use on the umbilical cord) 3-4 drops of breast milk for a maximum of 8 hours after birth is rubbed on umbilical stump. This will continue every 8 hours to two days after cord separation. Then, within 2-4 hours after birth ,a culture swab from the umbilical stump is sent to laboratory as baseline. Then, two other culture swabs from the umbilical stump, one at 3 days after birth and the other on the day that the umbilical cord was removed is sent to check bacterial colonization.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
NICU of Shahid Beheshti Hospital
Full name of responsible person
Dr. Amir Mohammad Armanian
Street address
Number 133, Shahid Ansari Alley, Saeb street, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr.Ebrahim Esfandiari
Street address
Isfahan University of Medical Sciences, Hezar Jirib, Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Department of pediatrics , Isfahan University of Medical Sciences, Isfahan, Iran
Full name of responsible person
Dr. Amir Mohammad Armanian
Position
Associate professor of neonatology
Other areas of specialty/work
Street address
Number 133, Shahid Ansari Alley, Saeb street
City
Isfahan
Postal code
Phone
+98 131294044
Fax
Email
armanian@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Child Growth and DeveLopment Research Center ,Isfahan University of Medical Science
Full name of responsible person
Dr. Amir Mohammad Armanian
Position
Associate professor of neonatology
Other areas of specialty/work
Street address
Number 133, Shahid Ansari Alley, Saeb street
City
Isfahan
Postal code
Phone
+98 31 3235 5059
Fax
Email
armanian@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Amir Mohammad Armanian
Position
Associate professor of neonatology
Other areas of specialty/work
Street address
Number133, Shahid Ansari Alley, Saeb street
City
Isfahan
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)