This research will be random clinical trial in two groups on 60 mothers having premature neonate (gestational age between 32–36 week) bed ridden in the NICU Mashhad University of medical science research and training centers. Sampling will be done based inclusion criteria. Control group will receive the typical unit programs While the intervention group includes families who are family partnership in tendance; as they are trained in premature neonate tendace in the field of basic care, including: the right way of washing hands at the time of entring the unit, before and after of touching the neonate, way of using incubator, changing bedsheet and diapers, way of breastfeeding and infant feeding then the infant will be weighed every morning up to the time of releasing, in two groups, breastfeeding self-efficocy questionnaire (Denis 2003) containing 14 questions this questionnaire will be compeleted in 3 steps. Firstly, in the first 24 hours after child birth; secoundly, before releasing and thirdly, in the eighth weeks. At the end the infant weight will be controlled in the eight week.
Inclusion criteria: ages between 32–36 weeks; Hemodynamic stubility; neonate family including first and secound degree relatives.
Exclusion criteria: neonate in the ventile; neonate with sepsis; family absence in the unit for more than one third of hospitalization time (intervention groups).
General information
Acronym
Family Centered Care (FCC)
IRCT registration information
IRCT registration number:IRCT2013081814393N1
Registration date:2013-09-21, 1392/06/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-09-21, 1392/06/30
Registrant information
Name
Zahra Askari Hoseini
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1859 1511
Email address
askarihz901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Financial Assistance Mashhad University of Medical Sciences
Expected recruitment start date
2013-09-01, 1392/06/10
Expected recruitment end date
2013-12-31, 1392/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Family Participation on Mother's Breast Feeding Self-Efficacy and Weight gain of Premature Neonate
Public title
The Effect of Family Participation on Mother's Breast Feeding Self-Efficacy and Weight gain of Premature Neonate
Purpose
Supportive
Inclusion/Exclusion criteria
Neonate inclusion criteria: age between 32 - 36 weeks; Hemodynamic stability (HR=120-160, RR = 40-60, SPO2= 85%-95% and baby pink color); Congenital anomaly is not clear; newborn premature infants who are hospitalized; at least seven days to be admitted; be the first child; IUGR not.
Family inclusion criteria: they agree to participate in the study; neonate family includes first and secound degree relatives; medical personnel are not; minimum education level reading and writing; have a natural physical ability; lack of mood disorders and emotional barriers to effective communication; drug abuse is not; have the possibility to participate in the study (Intervention group); during the first day of admission to attend; have lived in Mashhad.
Mother inclusion criteria: be nulliparous mothers; the desire to breastfeed is not a medical condition; there may be a phone call.
Neonate exclusion criteria: neonate dies; respiratory disease that has required ventilation; neonatal sepsis is.
Family exclusion criteria: withdraw from the study for any reason that is; in unit more than one third of neonates is absent the intervention group; notes do not observe trained and assigned tasks.
Age
From 32 years old to 36 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not 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
Mashhad University of Medical Sciences
Street address
School of Nursing and Midwifery Mashhad, Four ways PhD
City
Mashhad
Postal code
Approval date
2013-08-19, 1392/05/28
Ethics committee reference number
research/920541/1/111
Health conditions studied
1
Description of health condition studied
Disorders related to short gestation and low birth weight, not elsewhere classified
ICD-10 code
P07
ICD-10 code description
weight gain of premature neonate
Primary outcomes
1
Description
weight gain of premature neonate
Timepoint
Two months after the start of the intervention
Method of measurement
Weight in grams using a digital scale
2
Description
Mother's breastfeeding self-efficacy
Timepoint
Two months after the start of the intervention
Method of measurement
Dennis questionnaire
Secondary outcomes
1
Description
The rate of weight change
Timepoint
Two months after the start of the intervention
Method of measurement
Weight in grams with a digital scale
2
Description
The rate of mother's breastfeeding self-efficacy
Timepoint
Two months after the start of the intervention
Method of measurement
Dennis self-efficacy questionnaire
Intervention groups
1
Description
Control group will receive the typical unit programs. The intervention group includes families who are family partnership in tendance. they are trained in premature neonate tendace in the field of basic care, including: the right way of washing hands at the time of entring the unit, before and after of touching the neonate, way of using incubator, changing bedsheet and diapers, way of breastfeeding and infant feeding.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
NICU, Educational and Research Center Mashhad University of Medical Sciences
Full name of responsible person
Mr.Hamidreza Behnam Vashani
Street address
Mashhad School of Nursing and Midwifery
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Council of Mashhad University of Medical Sciences
Full name of responsible person
Dr.Tafaghodi
Street address
Building Qureshi
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Askari Hoseini
Position
MSc in Nursing,neonatal intensive care
Other areas of specialty/work
Street address
School of Nursing and Midwifery Mashhad, Four way Phd
City
Mashhad
Postal code
Phone
+98 51 1663 6215
Fax
Email
askarihz901@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Mashhad
Full name of responsible person
Hamidreza Behnam Vashani
Position
MSc Nursing,Faculty member of School of Nursing and Midwifery, Mashhad
Other areas of specialty/work
Street address
School of Nursing and Midwifery Mashhad, Four way Phd
City
Mashhad
Postal code
Phone
+98 51 1859 1511
Fax
Email
behnamhr@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Askari Hoseini
Position
MSc in Nursing,neonatal intensive care
Other areas of specialty/work
Street address
School of Nursing and Midwifery Mashhad, Four way Phd
City
Mashhad
Postal code
Phone
+98 51 1663 6215
Fax
Email
askarihz901@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)