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The effect of Home Visit Program based on the Continued kangaroo Mother Care on Maternal Resiliency and Development of Premature Infant

Protocol summary

Study aim
Determine the effect of home-based home visit program on maternal and neonatal care on maternal resilience and development of premature infants.
Design
This study is a randomized clinical trial with control group.In this research, sampling is carried out in a non-randomized manner.The allocation of the research units was based on randomized blocking method; that is,six scenarios are created for a four-block allocation in the first place, and then drawing lots is performed in order to arrange the blocks.The study population consisted 25 mothers in either group with premature 26-32 week old ,who were hospitalized in the NICU ward of omolbanin Hospital in Mashhad and met the inclusion criteria of the study.
Settings and conduct
Sampling in the NICU section of Omolbanin hospital. One Blind study
Participants/Inclusion and exclusion criteria
Neonates 26-32 weeks weighing more than 1000 gr\stable clinical status, inability to receive oxygen in an invasive way ,no anomaly based , Lack of grade III and IV IVH ,Lack of advanced recovery in the history
Intervention groups
Premature babies are 26-32 weeks old weighing more than 1000 gr.They are admitted to the neonatal intensive care unit ,and after the removal of the newborn from advanced mechanical ventilation and finding the conditions for caring for kmc up to the min daily clearance 3 times Kmc surveillance takes, and they continue to care for a month at the home after a discharge. At the beginning of the arrival of the mothers, will be completed by the maternity ward, the time of discharge, and one month after the discharge of the Conor Davidson resiliency scale. At 2 months of age, the modified age of the newborn will be evaluated evolutionally.In the control group, after the discharge, they receive routine care.
Main outcome variables
Maternal resilience, Conor and Davidson questionnaire , neonatal development ASQ

General information

Reason for update
Acronym
KMC
IRCT registration information
IRCT registration number: IRCT20181121041718N1
Registration date: 2019-02-16, 1397/11/27
Registration timing: registered_while_recruiting

Last update: 2019-02-16, 1397/11/27
Update count: 0
Registration date
2019-02-16, 1397/11/27
Registrant information
Name
marziyeh ghazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
ghazim3@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-10, 1397/10/20
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Home Visit Program based on the Continued kangaroo Mother Care on Maternal Resiliency and Development of Premature Infant
Public title
The effect of Home Visit Program based on the Continued kangaroo Mother Care on Maternal Resiliency and Development of Premature Infant
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Infant: Weight greater than or equal to 1000 g Gestational age 26 to 32 weeks Stable clinical situation Failure to receive oxygen in an aggressive way No anomaly based on the file Non intraventricular hemorrhage grade 3 or 4 No need for advanced neonatal resuscitation during hospitalization Mother: No known mental disorders Resident in Mashhad or Mashhad suburb Not addiction based on self-declaration There is no significant family challenge with the husband, based on self-declaration. Do not have twin or multiple delivery There is no history of premature baby birth
Exclusion criteria:
Infant: Respiratory instability and need for aggressive mechanical ventilation Baby death Occurrence of significant stressful events during research Having chronic physical or mental illness
Age
From 1 day old to 7 days old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
This study is a randomized clinical trial with control group. In this research, sampling (inclusion of mothers and their neonates in the study) is carried out in a non-randomized manner. The allocation of the research units to intervention and control groups was based on randomized blocking method; that is, six scenarios are created for a four-block allocation in the first place, and then drawing lots is performed in order to arrange the blocks
Blinding (investigator's opinion)
Single blinded
Blinding description
The analyst will be unaware of the intervention and control groups
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of Mashhad University of Medical Sciences
Street address
University Street, Avicenna Street, Faculty of Nursing and Midwifery
City
mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2019-01-01, 1397/10/11
Ethics committee reference number
IR.MUMS.NURSE.REC.1397.074

Health conditions studied

1

Description of health condition studied
Maternal resilience and the development of preterm infants receiving maternal and neonatal care through home visits
ICD-10 code
P07.3
ICD-10 code description
Other preterm infants - 28 completed weeks or more but less than 37 completed weeks (196 completed days but less than 259 completed days) of gestation.

Primary outcomes

1

Description
Resilience of mothers of premature infants
Timepoint
The newborn is admitted to the infant's care unit, when the baby is given discharge, one month after the discharge
Method of measurement
Connor Davidson Questionnaire(2003)

2

Description
Premature infants development
Timepoint
2 months old corrected age
Method of measurement
Development questionnaire ASQ

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Premature babies are between 26-32 weeks old weighing more than 1000 grams. They are admitted to the neonatal intensive care unit and have criteria for entering the study, and after the removal of the newborn from advanced mechanical ventilation and finding the conditions for caring for kmc up to the minimum daily clearance Three times kmc surveillance takes place for 30-40 minutes, and they continue to care for a month at the home after a discharge. At the beginning of the arrival of the mothers, the intervention group will be completed by the maternity ward, the time of discharge, and one month after the discharge of the Conor Davidson resiliency scale. At 2 months of age, the modified age of the newborn will be evaluated evolutionally.
Category
Prevention

2

Description
Control group: Premature babies are between 26-32 weeks old weighing more than 1000 grams. They are admitted to the neonatal intensive care unit and have criteria for entering the study, and after the removal of the newborn from advanced mechanical ventilation and finding the conditions for caring for kmc up to the minimum daily clearance Three times, they perform kangaroo care for 30-40 minutes and receive routine care after discharge. At the beginning of the arrival of the mothers, the intervention group will be completed by the maternity ward, the time of discharge, and one month after the discharge of the Conor Davidson resiliency scale. At 2 months of age, the modified age of the newborn will be evaluated evolutionally.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Omolbanin hospital
Full name of responsible person
Marziye ghazi
Street address
Bahjat 16,Ayatollah Behjat Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9144734756
Phone
+98 51 3223 1062
Fax
+98 51 3223 1444
Email
Ghazim3@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Tafaghodi Mohsen
Street address
University St, Facing University Street 18, Deputy of University Technology and Research
City
Mashhad
Province
Razavi Khorasan
Postal code
917751365
Phone
+98 51 3841 2081
Email
Tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Marziye ghazi
Position
Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Mashhad, Ebne sina St, Nursing and Midwifery Faculty
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Ghazim3@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zare Masoud
Position
Tutor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Mashhad, Ebne sina St, Nursing and Midwifery Faculty
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 913 791 3199
Email
Zaremd@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Marziye ghazi
Position
Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Mashhad, Ebne sina St, Nursing and Midwifery Faculty
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Ghazim3@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
The total potential data can be shared after unidentifiable people
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
The data can be used for other human research and health centers
From where data/document is obtainable
Library of the School of Nursing and Midwifery of Mashhad, ghazim3@mums.ac.ir
What processes are involved for a request to access data/document
Visit the Library of Nursing and Midwifery Faculty of Mashhad
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