Effect of planned breastfeeding education to mothers versus control group on the weight gaining in low birth weight newborns: a randomized clinical trial
To assess the effect of planned breastfeeding education to mothers versus control group on the weight gaining in low birth weight newborns
Design
This is a randomized clinical trial with control group, in which eligible patients will be randomly assigned through the block randomization to the intervention and control groups
Settings and conduct
This study will be performed in the Fatemieh Hospital in Hamadan city on 40 eligible pregnant women. The patients will be randomly assigned to the intervention and control groups through the block randomization. Blinding is not possible in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 1 to 29 days;
Birth weight between 1500 to 2499 gr;
Literate mother;
Exclusion criteria:
Multiple twins;
Mother addiction;
Congenital malformations
Pregnancy or breastfeeding
Intervention groups
Intervention group:
Routine care of mother and child during breastfeeding in addition to five 20-minute sessions planned breastfeeding education at intervals after delivery, 24 hours after delivery, and days 5, 15, and 60 postpartum, including how to properly hug the baby, to the breast infant placement, signs of effective sucking, benefits of exclusive breastfeeding, frequent feeding of the baby around the clock, duration of feeding the baby, avoiding the use of glass, proper milking method, providing a manual
Control group:
Routine care of mother and child during breastfeeding
Main outcome variables
Primary outcome:
Measuring birth weight
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N421
Registration date:2022-04-14, 1401/01/25
Registration timing:retrospective
Last update:2022-04-14, 1401/01/25
Update count:0
Registration date
2022-04-14, 1401/01/25
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of planned breastfeeding education to mothers versus control group on the weight gaining in low birth weight newborns: a randomized clinical trial
Public title
Effect of planned breastfeeding education to mothers versus control group on the weight gaining in low birth weight newborns
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 1 to 29 days;
Birth weight between 1500 to 2499 gr;
Literate mother;
Exclusion criteria:
Multiple twins;
Mother addiction;
Congenital malformations
Pregnancy or breastfeeding
Age
From 1 day old to 29 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2015-11-24, 1394/09/03
Ethics committee reference number
IR.UMSHA.REC.1394.335
Health conditions studied
1
Description of health condition studied
Low birth weight
ICD-10 code
P07.1
ICD-10 code description
Other low birth weight newborn
Primary outcomes
1
Description
Measuring birth weight
Timepoint
On 1, 15 , 60 days after birth
Method of measurement
Using standard scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine care of mother and child during breastfeeding in addition to five 20-minute sessions planned breastfeeding education at intervals after delivery, 24 hours after delivery, and days 5, 15, and 60 postpartum, including how to properly hug the baby, to the breast infant placement, signs of effective sucking, benefits of exclusive breastfeeding, frequent feeding of the baby around the clock, duration of feeding the baby, avoiding the use of glass, proper milking method, providing a manual
Category
Treatment - Other
2
Description
Control group: Routine care of mother and child during breastfeeding
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital in Hamadan city
Full name of responsible person
Sahar Rahmani
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
sahar.r70a@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Sahar Rahmani
Position
Midwifery Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
sahar.r70a@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Roya Amini
Position
Master of Community Health
Latest degree
Master
Other areas of specialty/work
Public Health/Community Medicine
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
aminiroy@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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