Objective: Comparing the effect of human milk topical application and dry cord care on cord separation time. Methods: This research was a randomized clinical trial on 130 singleton and mature newborns who born in Rasi hospital in Ghaemshahr, Iran. Newborns were placed randomly in groups of topical application of human milk and dry cord care. The umbilical separation time was compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102145830N1
Registration date:2011-12-03, 1390/09/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-12-03, 1390/09/12
Registrant information
Name
Azar Aghamohammadi
Name of organization / entity
Islamic Azad University, Sari Branch
Country
Iran (Islamic Republic of)
Phone
+98 15 1325 3179
Email address
azareaghamohamady@iausari.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University, Sari Branch
Expected recruitment start date
2011-02-06, 1389/11/17
Expected recruitment end date
2011-03-08, 1389/12/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of topical application of human milk and dry cord care on umbilical cord separation time in healthy newborn infants
Public title
The effect of topical application of human milk on umbilical cord
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: normal neonates with gestational age between 37-42 weeks; first minute Apgar equal to or more than 7; fed breast milk and mother and newborn were roommates after birth. Exclusion criteria: existence of any disease or congenital malformation; immediate need to assay and treat the newborn after birth; rupture in amnionitic membrane more than 12 hours; suffering from urinary system infection in mothers; newborn suffered from respiratory distress, prenatal asphyxia, metabolic diseases; thick and jellatinous umbilical cord which needs two clumps; hyperbilirubinemia and any problem that caused the newborn to be taken to NICU.
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
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
Mazandaran University of Medical Sciences
Street address
Mazandaran University of medical sciences, three way of Joubar
City
Sari
Postal code
Approval date
2011-02-06, 1389/11/17
Ethics committee reference number
4/1704
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 separartion time
Timepoint
one time after umbilical cord separartion
Method of measurement
observation, in hours
Secondary outcomes
1
Description
Bleeding continuation after separation
Timepoint
after separation
Method of measurement
observation, daily
Intervention groups
1
Description
topical application of human milk in umbilical cord care
Category
Treatment - Other
2
Description
dry cord care in umbilical cord care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Street address
City
Ghaemshahr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University, Sari Branch
Full name of responsible person
Mohsen Rabani
Street address
Islamic Azad University, Sari Branch
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Sari Branch
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
Islamic Azad University, Sari Branch
Full name of responsible person
Azar Aghamohammadi
Position
faculty member
Other areas of specialty/work
Street address
Islamic Azad University, Sari Branch
City
Sari
Postal code
Phone
+98 911 351 4912
Fax
Email
azareaghamohamady@iausari.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Sari Branch
Full name of responsible person
Azar Aghamohammadi
Position
phd student
Other areas of specialty/work
Street address
Islamic Azad University, Sari Branch
City
Sari
Postal code
Phone
+98 911 351 4912
Fax
Email
azareaghamohamady@iausari.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)