Protocol summary

Study aim
"Design, Development, and Evaluation of Mobile-Based Intelligent Software for Educating Parents on Care for Premature Infants Discharged from the Neonatal Intensive Care Unit
Design
The clinical trial consists of two groups: intervention and control, conducted in parallel, unblinded, randomized fashion, involving 58 parents of premature infants. Randomization will be done using sealed envelopes.
Settings and conduct
This study conducted from 22 October 2024 to 19 February 2025, spanning 4 months, on parents of premature infants hospitalized in the neonatal intensive care unit (NICU), If consent is obtained, premature infants to participate in the study, parents will be allocated to intervention and control groups. In the intervention group, parents will initially receive training on using a software application, which will then be installed on their smartphones. In the control group, no software will be installed, and routine instructions and reminders will be provided according to current practices.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Parents of premature infants admitted to the neonatal intensive care unit at Imam Reza Hospital who express a willingness to participate in the study. Exclusion criteria: Exclusion criteria include not owning a smartphone and expressing dissatisfaction with participation in the study.
Intervention groups
In the intervention group, parents will initially receive training on using a software application, which will then be installed on their smartphones. In the control group, no software will be installed, and routine instructions and reminders will be provided according to current practices.
Main outcome variables
Parental satisfaction Developmental assessment and Growth Evaluation of necessary actions (ophthalmological examination, hearing screening, vitamin and supplement intake)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240607062035N1
Registration date: 2024-09-18, 1403/06/28
Registration timing: prospective

Last update: 2024-09-18, 1403/06/28
Update count: 0
Registration date
2024-09-18, 1403/06/28
Registrant information
Name
Marjan rasoulian Kasrineh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2499
Email address
rasoulian.mr@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-22, 1403/08/01
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
"Design, Development, and Evaluation of Mobile-Based Intelligent Software for Educating Parents on Care for Premature Infants Discharged from the Neonatal Intensive Care Unit
Public title
Design, Development, and Evaluation of Mobile-Based Intelligent Software for Educating Parents on Care for Premature Infants Discharged
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Parents of premature infants admitted to the neonatal intensive care unit at Imam Reza Hospital are interested in participating in the study.
Exclusion criteria:
Age
From 6 months old to 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 58
Randomization (investigator's opinion)
Randomized
Randomization description
Upon discharge from the neonatal intensive care unit, parents of premature infants will be randomly allocated into two groups (intervention and control) using blocked randomization method. Allocation will be performed using sealed envelopes prepared by a research team member. The randomization sequence will be generated using a randomization system (www.randomize.com) designed with blocked randomization. Envelopes will be sealed to ensure that the contents are not visible from the outside. The study's purpose will be explained to eligible individuals, who can choose to pick an envelope, open it, and based on its contents, be assigned to either the intervention or control group. Each envelope will contain the participant's name, surname, age, and mobile number. Participants assigned to the intervention group will initially receive training on software usage, and the software will be installed on their smartphones.
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
Deputy of Research of Mashhad University of Medical Sciences
Street address
Deputy of Research of Mashhad University of Medical Sciences, Faculty of Medicine, Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
8771685873
Approval date
2024-08-05, 1403/05/15
Ethics committee reference number
IR.MUMS.IRH.REC.1403.105

Health conditions studied

1

Description of health condition studied
Retinopathy of Prematurity among Preterm Infants
ICD-10 code
E08.31
ICD-10 code description
Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy

Primary outcomes

1

Description
The level of parents' satisfaction with the education received
Timepoint
4 Months
Method of measurement
questionnaire

2

Description
Assessment of evolution with the Denver test
Timepoint
1 year
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, parents are first taught how to use the software and the software is installed on their smartphones
Category
Diagnosis

2

Description
Control group: will receive routine education and reminders according to the current standard procedure.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Neonatal Intensive Care Unit at Imam Reza Hospital
Full name of responsible person
Ezat khodashenas
Street address
Imam Reza Hospital, Ahmad Abad Street, Mashhad, Khorasan Razavi, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9178113456
Phone
+98 915 301 1056
Email
khodashenase@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ezat khodashenas
Street address
Deputy of Research of Mashhad University of Medical Sciences, Faculty of Medicine, Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Phone
+98 915 301 1056
Email
khodashenase@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
Marjan Rasoulian Kasrineh
Position
Research Assistant
Latest degree
Master
Other areas of specialty/work
Medical Informatics
Street address
Department of Medical Informatics - Faculty of Medicine of Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Phone
+98 51 3800 2499
Email
rasouliankm2@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ezat khodashenas
Position
Associate Professor of Pediatrics
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Deputy of Research of Mashhad University of Medical Sciences, Faculty of Medicine, Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Phone
+98 51 3800 2499
Email
khodashenase@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Marjan Rasoulian Kasrineh
Position
Research assistant
Latest degree
Master
Other areas of specialty/work
Medical Informatics
Street address
Department of Medical Informatics - Faculty of Medicine of Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Phone
+98 51 3800 2499
Email
rasouliankm2@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
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