Determine of the effect of father's education and participation on the success rate of breastfeeding in mothers with preterm infant
Design
Clinical trial with control group, with parallel groups, three blind, randomized
Settings and conduct
In this study, mothers with preterm infants with less than 37 weeks of gestational age at Imam Reza Hospital of Kermanshah are examined. Infants are randomly divided into two groups: intervention and control. In the intervention group, fathers receive three-session training on breastfeeding and infant feeding while in the control group only routine training is performed. The study is a three-blind study which both mothers and both the assessor and the analyst are not aware of the allocation of groups.
Participants/Inclusion and exclusion criteria
gestational age less than 37 week; non of asphyxia during infant's birth; non of heart problems and serious congenital anomalies; do not use hypnotic drugs by infant; non of congenital malformation and abnormalities in the jaw and mouth
Intervention groups
In the intervention group, infant̕ s fathers will be taught three face-to-face sessions on infant nutrition, lactation problems, and breastfeeding benefits. At the end of the session, a leaflet with the main points of the session was provided to the fathers. In the control group, training sessions were not provided and only routine training was given to fathers.
Main outcome variables
The frequency of breastfeeding; the number of correct breastfeeding; the success rate of the mother in breastfeeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151220025619N3
Registration date:2018-03-16, 1396/12/25
Registration timing:prospective
Last update:2018-03-16, 1396/12/25
Update count:0
Registration date
2018-03-16, 1396/12/25
Registrant information
Name
Leila Mohammadi Pirkashani
Name of organization / entity
Esfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3835 7294
Email address
mohammadi.p@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of father's education and participation on the success rate of breastfeeding in mothers with preterm infant
Public title
The effect of father's education and participation on the success rate of breastfeeding in mothers with preterm infant
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
gestational age less than 37 week
Exclusion criteria:
Asphyxia during infant's birth
Heart problems and serious congenital malformations of the infant
Use hypnotic drugs
Congenital malformation and abnormalities in the jaw and mouth
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the newborns were randomly assigned to two random groups using a random number table. A random numbered table is a collection of numbers that are generated without a specific pattern or order and in a completely random manner. To use the random number table, the researcher must first determine the number of the table to read (for example: up, down, left or right), the second assumption is that the researchers will consider the numbers for different groups, in this study paired numbers will be assigned to the intervention group in the random numbers table and the individual numbers will be assigned to the control group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
For blinding, for mothers not to understand, the fathers of both groups are trained, The difference is that the fathers of the control group receive only routine training. The evaluator, also helping the researcher, is not aware of the allocation of the groups and the analyst is not aware of the allocation of groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Imam Reza Hospital., Nurse Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715838316
Approval date
2018-02-28, 1396/12/09
Ethics committee reference number
IR.KUMS.REC.1396.692
Health conditions studied
1
Description of health condition studied
Breastfeeding in mothers with preterm infant
ICD-10 code
O92.7
ICD-10 code description
Other and unspecified disorders of lactation
Primary outcomes
1
Description
The success rate of breastfeeding in mothers with preterm infants
Timepoint
End one month, three months and six months
Method of measurement
Researcher made questionnaire
Secondary outcomes
1
Description
Maternal Satisfaction Score from Breastfeeding
Timepoint
6 months
Method of measurement
Researcher made questionnaire
Intervention groups
1
Description
Intervention group: The fathers of the intervention group were interviewed and offered a face-to-face, 40-minute session about infant feeding and the difficulties sometimes associated with breastfeeding, such as fear of milk insufficiency; hand expression breast milk; teaching of feeding methods in preterm infants such as feeding by cup; return to outside employment in working mothers; and problems such as breast engorgement, mastitis, sore and inverted nipples or flat nipples and breast refusal. They were taught how problems with lactation can occur and how it is possible to prevent and manage them. Moreover, attention was paid to the concerns that a father might have in relation to breastfeeding, and the fathers were helped to recognize and accept their unique and vital role in the success of breastfeeding especially in mothers with preterm infants. At the end of the session, a leaflet with the main points of the session was provided to the fathers. The nurse who conducted the intervention was trained through the training course.
Category
Behavior
2
Description
Control group: In the control group, training sessions were not provided and only routine training was given to fathers.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital Kermanshah
Full name of responsible person
Leila Mohammadi Pirkashani
Street address
Imam Reza Hospital., Nurse Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715838316
Phone
+98 83 3835 7294
Email
mohammadi1607@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research of Kermanshah University of Medical Sciences
Full name of responsible person
Dr Farid Najafi
Street address
Imam Reza Hospital., Nurse Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715838316
Phone
+98 83 3835 7294
Email
mohammadi1607@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research of Kermanshah University of Medical Sciences
Proportion provided by this source
5
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
Kermanshah University of Medical Sciences
Full name of responsible person
Leila Mohammadi Pirkashani
Position
Master of Science in Neonatal Intensive Care Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital., Nurse Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715838316
Phone
+98 83 3835 7294
Email
mohammadi1607@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Leila Mohammadi Pirkashani
Position
Master of Science in Neonatal Intensive Care Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital., Nurse Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715838316
Phone
+98 83 3835 7294
Email
mohammadi1607@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Leila Mohammadi Pirkashani
Position
Master of Science in Neonatal Intensive Care Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital., Nurse Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715838316
Phone
+98 83 3835 7294
Email
mohammadi1607@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD