Protocol summary

Summary
Objective: This study aims at determine the effect of counseling on exclusive breastfeeding continuation in mothers with hospitalized preterm infant is designed, 2014.Exclusion criteria: Singleton pregnancy; Delivery at 37-34 weeks gestation; No abnormalities in the baby at birth. Exclusion criteria: Infant mortality for any cause during the study; infants with severe respiratory distress and infection hospital in need of Nil Per Os; Continued absence of women in training sessions. Methods: This is quasi-experimental study of two groups.The target population of this study consists of all mothers and hospitalized premature infants. Sample size of 62 patients in the intervention group and 62 patients in the control group are determined. Sampling is done by random permutation block. In order to continue exclusive breastfeeding and breastfeeding counseling intervention in preterm infants during the five sessions by the researcher, daily during hospitalization for direct instruction and individual face to face, the theoretical and practical on the steps of reproductive health service (Using the replica, pamphlets, educational compact Disk training) and incentive packages and daily goals chart will be performed. But the control group will performed routine care. Data collection tools included three questionnaires to assess knowledge of mothers about breastfeeding; Training based on structural BASNEF model, demographic characteristics, check list observation and consultation performance breastfeeding mothers, and scales weighing children's model co12000 is made in Iran.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014111013405N6
Registration date: 2015-01-05, 1393/10/15
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-01-05, 1393/10/15
Registrant information
Name
Seyyedeh Zahra Masoumi
Name of organization / entity
Hamedan University of Medical Sciences, School of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0150
Email address
zahra.masoomi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-05-22, 1394/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of counseling on exclusive breastfeeding continuation in mothers with hospitalized preterm infant using BASNEF model
Public title
The effect of counseling on breast feeding in preterm infants
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Mother are literate; Mother prevention of adduction; Not having a mother with underlying disease and gestational diabetes and preeclampsia; Singleton pregnancy; Delivery at 37-34 weeks gestation; No abnormalities in the baby at birth. Exclusion criteria: Mother's unwillingness to cooperate; Metabolic disorders in newborns; Infant mortality for any cause during the study; infants with severe respiratory distress and infection hospital in need of Nil Per Os; Continued absence of women in training sessions; Mothers taking antidepressant drugs and psychotropic substances; The inability of the breast feeding at the discretion of the physician; Infectious disease of the breast; Unavailability of the mother at the time of completing of questionnaires test and attending breastfeeding education classes during pregnancy.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 124
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 Hamedan university of Medical Scienses
Street address
Vice Chancellor of Research and Technology, Hamedan University of Medical Sciences, Shahid Fahmideh Avenue, Hamedan
City
Hamedan
Postal code
6516645977
Approval date
2014-11-25, 1393/09/04
Ethics committee reference number
16/35/9/4125/پ

Health conditions studied

1

Description of health condition studied
Relationship counseling to exclusive breastfeeding continuation in mothers with hospitalized preterm infant
ICD-10 code
p05-po6-p0
ICD-10 code description
Disorders related to length of gestation and fetal growth

Primary outcomes

1

Description
exclusive breastfeeding continuation
Timepoint
Before then once monthly until 4 months after birth
Method of measurement
Check list

Secondary outcomes

1

Description
Birth weight
Timepoint
Before then once monthly until 4 months after birth
Method of measurement
Weighing Scales babies

Intervention groups

1

Description
Intervention group: breastfeeding counseling for continued exclusive breastfeeding in preterm infants during 5 session by researcher, daily during hospitalization direct instruction and individual face to face, the practical and theoretical will be performed.
Category
Prevention

2

Description
Control group: regular and ongoing training by personnel neonatal unit and after delivery to receive.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Street address
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Research the Technology, Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeed Bashiriyan
Street address
HVice Chancellor of Research and Technology, Hamedan University of Medical Sciences, Shahid Fahmideh Avenue, Hamedan
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research the Technology, Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Seyedeh Zahra Masoumi
Position
Phd in reproductive health, Vice chancellor for the School of Nursing and Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamedan University of Medical Sciences, Shahid Fahmideh Avenue, Hamedan
City
Hamedan
Postal code
6516845977
Phone
+98 81 3838 0150
Fax
+98 81 3838 0447
Email
zahramid2001@yahoo.com; zahra.masoomi@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Sayedeh Zahra Masoumi
Position
Ph.D of reproductive health
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamedan University of Medical Sciences, Shahid Fahmideh Avenue, Hamedan
City
Hamedan
Postal code
6516645977
Phone
+98 81 3838 0150
Fax
+98 81 3838 0447
Email
zahramid2001@yahoo.com; zahra.masoomi@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Shiler Ahmadi
Position
Bachelor of Midwifery/ Student of Master in Midwifery Counselling
Other areas of specialty/work
Street address
Fahmideh Ave, School of nursing and midwifery,Hamedan University of Medical Sciences, Hamedan, Iran
City
Hamedan
Postal code
6516845977
Phone
+98 87 3324 5299
Fax
Email
ahmadi.sh64@gmail.com
Web page address

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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