Investigating the role of educating and follow up by discharge nurse on retinopathy prevention in neonates admitted to neonatal intensive care unit of shahid beheshti hospital in kashan at 2018
Determining the role of educating and follow up by discharge nurse on retinopathy prevention in neonates admitted to neonatal intensive care unit
Design
Quasi-experimental study with control group
Settings and conduct
60 eligible mothers with premature newborns who were referred to neonatal intensive care unit of Shahid Beheshti Hospital affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: parental consent for participation in the research; gestational age less than 37 weeks. Exclusion criteria: parental unwillingness to participate in the continuation of the project; baby's feet.
Intervention groups
Intervention group: Pre-discharge teaching, screening of premature infants in terms of ROP, telephone follow-up of post-discharge visual examinations, and caregivers education about the necessary care before eye examinations.
Control group: hospital’s routine program was implemented included some teaching pamphlet and giving the referral form to the ROP clinic and the neonate discharge summary sheet at the time of discharge to the parents.
Main outcome variables
The number of visit the ophthalmologists to prevent retinopathy; relative frequency of retinopathy.
General information
Reason for update
Acronym
ROP
IRCT registration information
IRCT registration number:IRCT20180506039545N1
Registration date:2018-05-24, 1397/03/03
Registration timing:prospective
Last update:2018-05-24, 1397/03/03
Update count:0
Registration date
2018-05-24, 1397/03/03
Registrant information
Name
Amir Ahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7527
Email address
amir.ahmadi@nmmail.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-31, 1397/03/10
Expected recruitment end date
2018-10-02, 1397/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the role of educating and follow up by discharge nurse on retinopathy prevention in neonates admitted to neonatal intensive care unit of shahid beheshti hospital in kashan at 2018
Public title
Investigating the role of educating and follow up by discharge nurse on retinopathy prevention in neonates
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Parental consent for participation in the research
Gestational age more than 32 and less than 37 weeks
Birth weight less than 2,000 gr
Exclusion criteria:
Parental unwillingness to participate in the continuation of the project
Baby's feet
Absence, cooperation and participation in eye examination sessions (up to 2 consecutive sessions)
The impossibility of making phone calls with the caregiver of the infant with ROP at a given time
The absence of the parent or the caregiver of the infant in the training sessions during hospitalization or during discharge
Neonates’ discharge before the end of study
Age
From 1 day old to 28 days 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
Ethics Committee of Isfahan University Medical sciences
Street address
Pediatric and Neonatal Department, School of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jerib Avenue, Darvazeh Shiraz, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2018-04-06, 1397/01/17
Ethics committee reference number
IR.MUI.REC.1397.3.001
Health conditions studied
1
Description of health condition studied
Retinopathy
ICD-10 code
P07.17
ICD-10 code description
Other low birth weight newborn, 1750-1999 grams
Primary outcomes
1
Description
The number of visit the ophthalmologists to prevent retinopathy
Timepoint
At the end of the fourth month after the intervention
Method of measurement
Checklist
2
Description
Relative frequency of retinopathy
Timepoint
At the end of the fourth month after the intervention
Method of measurement
Checklist
3
Description
Stage and region of retinopathy involvement
Timepoint
At the end of the fourth month after the intervention
Method of measurement
Checklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: pre-discharge teaching, screening of premature infants in terms of ROP, telephone follow-up of post-discharge visual examinations, and caregivers education about the necessary care before eye examinations
Category
Prevention
2
Description
Control group: hospital’s routine program was implemented included some teaching pamphlet and giving the referral form to the ROP clinic and the neonate discharge summary sheet at the time of discharge to the parents.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Mehran Sharifi
Street address
The Neonatal Intensive Care Unit, Shahid beheshti hospital, Pezeshk Blvd, 5th of Qotb–e Ravandi,Kashan city, Iran
City
Kashan
Province
Isfehan
Postal code
87159-1151
Phone
+98 31 5554 0026
Fax
+98 31 5554 8900
Email
amir.ahmadi@nmmail.mui.ac.ir
Web page address
http://beheshti.kaums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy-Javanmard
Street address
Vice Chancellor for Research Affairs, Esfahan University of Medical Sciences, Hezarjarib Street
City
Isfahan
Province
Isfehan
Postal code
87159-1151
Phone
+98 31 3668 8138
Fax
+98 31 3668 7898
Email
sh_haghjoo@med.mui.ac.ir
Web page address
http://research.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Amir Ahmadi
Position
Student of Master of Science in Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Pediatric and Neonatal Department, School of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jerib Avenue, Darvazeh Shiraz, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Fax
+98 31 3668 5149
Email
amir.ahmadi@nmmail.mui.ac.ir
Web page address
https://mui.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sedigheh Talakoub
Position
Master of Science in Nursing, Member of Academic
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pediatric and Neonatal Department, School of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jerib Avenue, Darvazeh Shiraz, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 2906
Fax
+98 31 3668 5149
Email
talakoub@nm.mui.ac.ir
Web page address
https://mui.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sedigheh Talakoub
Position
Master of Science in Nursing, Member of Academic
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pediatric and Neonatal Department, School of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jerib Avenue, Darvazeh Shiraz, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 2906
Fax
+98 31 3668 5149
Email
talakoub@nm.mui.ac.ir
Web page address
https://mui.ac.ir/
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
There is no further information.
Study Protocol
No - There is not 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