The Effect of Mother-Newborn Skin-to-skin Contact Education during first two months of newborn life on Exclusive Breastfeeding
Design
A randomized, controlled clinical trial with control group
Settings and conduct
The aim of this study was to investigate the effect of skin and skin contact between mother and baby on the success rate of exclusive breastfeeding, infant colic, reflux, and child growth in 3 to 5-day-old infants referred to the Valfajr Clinic. How to do skin-to-skin contact is that the mother is asked to bare her baby (diaper only) between her two bare breasts, at least 1 hour per day. The control group will not receive any training on the benefits of skin contact with the skin.
Participants/Inclusion and exclusion criteria
Entry criteria: Infants' mothers and infants within 3 to 5 days of age
Mother tends to participate in the study. Mothers who have breastfed up to 3 to 5 days old. Exclusive criteria: Illiterate mothers, Mothers with conditions and illnesses that are contraindicated in breastfeeding. Infants with conditions and diseases that are contraindicated in lactation
Intervention groups
The mothers are in the intervention group is recommended skin-to-skin contact at least 60 minutes per day. The control group will not train on the benefits skin-to-skin contact.
Main outcome variables
Exclusive breastfeeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190622043966N1
Registration date:2019-09-02, 1398/06/11
Registration timing:registered_while_recruiting
Last update:2019-09-02, 1398/06/11
Update count:0
Registration date
2019-09-02, 1398/06/11
Registrant information
Name
Leila Elmi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6651 2396
Email address
sadr.z@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Mother-Newborn Skin-to-skin Contact Education during first two months of newborn life on Exclusive Breastfeeding
Public title
Skin -to-Skin Contact Education
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All Mother and Newborn in 3 to 5 day from life of newborn that refer to valfajre clinic
Exclusion criteria:
Illiterate mothers
Mothers with conditions and disease that are contraindications to breastfeeding .Includes :Psychiatric disorders ، substance abuse ،active infectious disease such as TB and AIDS ،and the use of drugs to prevent lactation such as chemotherapy drugs
Infants with conditions and disease that are contraindications to breastfeeding .includes :Cleft palate، Galactosemia ، Phenylketonuria
Age
From 3 days old to 5 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
135
Randomization (investigator's opinion)
Randomized
Randomization description
Blocking :At the beginning of the project ، based on the random four - way blocking method ، the pocket will be provided to the researcher ، which at the beginning of each day will open one of them without disturbing ، and the letter contained in the envelope will be based on the contract. The previous one will show that the patients will be in the intervention group(Skin -to -SKIN contact Education )that day ، or in the control group.
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
Iranian Nationl Comitee for ethics in biomedical research
Street address
Dashegib Street, West of Tehran Health Center, Valfajr Clinic
City
Tehran
Province
Tehran
Postal code
1444643961
Approval date
2019-06-10, 1398/03/20
Ethics committee reference number
IR.IUMS.FMD.REC.1398.111
Health conditions studied
1
Description of health condition studied
Skin-to- skin contact and its effects on exclusive breastfeeding
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Exclusive Breastfeeding
Timepoint
3 to 5 days and end of first two months of life
Method of measurement
Self-declaration
Secondary outcomes
1
Description
Baby crying rate
Timepoint
3 to 5 days and end of first two months of life
Method of measurement
Self-declaration
2
Description
Baby Sleep Rates
Timepoint
3 to 5 days and end of first two months of life
Method of measurement
Self-declaration
3
Description
Quality of life for mothers
Timepoint
3 to 5 days and end of first two months of life
Method of measurement
SF-12 questionnaire
4
Description
Weight at 2 months
Timepoint
3 to 5 days and end of first two months of life
Method of measurement
Digital scales
5
Description
Height at 2 months
Timepoint
3 to 5 days and end of first two months of life
Method of measurement
Height gauge
6
Description
Head circumcision
Timepoint
3 to 5 days and end of first two months of life
Method of measurement
centimeter
Intervention groups
1
Description
Intervention group: Maternal and infant Skin -to- Skin contact Education during the first two months of life at least 1 hour per day in two first months
Category
N/A
2
Description
Control group:no training in the field of benefit skin-to-skin contact
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
valfajr clinic
Full name of responsible person
Leila Elmi
Street address
Dashegib Street, West of Tehran Health Center, Valfajr Clinic
City
Tehran
Province
Tehran
Postal code
1444683961
Phone
+98 21 6651 2396
Email
elmi12leila@yahoo.com
Web page address
http://cio.iums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Sadr
Street address
Dashegib Street, West of Tehran Health Center, Valfajr Clinic
City
Tehran
Province
Tehran
Postal code
1444643961
Phone
+98 21 6651 2396
Email
elmi12leila@yahoo.com
Web page address
http://fmd.iums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
leila Elmi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Family Physician
Street address
خیابان دستغیب مرکز بهداشت غرب تهران کلینیک ولفجر
City
Tehran
Province
Tehran
Postal code
1444643961
Phone
+98 66512396
Email
elmi12leila@yahoo.com
Web page address
http://fmd.iums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Sadr
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Dastgeib Street, West of Tehran Health Center, Valfajr Clinic
City
Tehran
Province
Tehran
Postal code
1444643961
Phone
+98 21 6651 2396
Email
elmi12leila@yahoo.com
Web page address
http://fmd.iums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Elmi Leila
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Family Physician
Street address
Dastgeib Street, West of Tehran Health Center, Valfajr Clinic
City
TEhran
Province
Tehran
Postal code
1444643961
Phone
+98 21 6651 2396
Email
elmi12leila@yahoo.com
Web page address
http://fmd.iums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available