Assessment of the Effect of Educational Intervention with a Smart Phone Mobile Application on the Neurodevelopmental Status of Infants admitted in NICU of Vali-E-Asr Hospital
Determining the effect of an educational intervention with a mobile phone application on the neurodevelopmental status of infants with a history of hospitalization in the NICU
Design
A randomized controlled trial, parallel design, not blinded with, 140 people (two groups of 70 people), divided by random numbers table.
Phasing is not applicable.
Settings and conduct
Infants born in Vali-E-Asr Hospital with a history of hospitalization in the NICU are randomly divided into two groups, and the parents/caregivers of one of them will receive an educational intervention with the upcoming mobile application, in addition to routine training. Comparison of 2 groups in terms of developmental status will be done with ASQ test and Baley tool in the first 6 months of life.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All vulnerable children with a history of NICU hospitalization and outpatient admission at the Development Clinic
Exclusion criteria: unwillingness of parents/caregivers to cooperate
Intervention groups
Children with a history of hospitalization in the NICU were randomly divided into two groups, and educational intervention with a mobile phone application was given to the parents/caregivers of one of the two groups, in addition to the routine trainings of the Evolution Clinic, from before the end of the neonatal period (28 days) until the end of 6 months. Routine training includes massaging the infant and targeted games with him, which is based on the UNICEF protocol (Care for Child Development), and is taught to the caregivers by a growth and development specialist. Educational intervention also includes sensory-motor, social-emotional and cognitive games appropriate to the child's age and periodic evaluation of these skills.
Main outcome variables
Children's neurodevelopmental disorder; The level of satisfaction of parents
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190416043290N3
Registration date:2023-08-04, 1402/05/13
Registration timing:registered_while_recruiting
Last update:2023-08-04, 1402/05/13
Update count:0
Registration date
2023-08-04, 1402/05/13
Registrant information
Name
Raheleh Moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6659 1316
Email address
raheleh.moradi1987@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the Effect of Educational Intervention with a Smart Phone Mobile Application on the Neurodevelopmental Status of Infants admitted in NICU of Vali-E-Asr Hospital
Public title
The effect of educational program of mobile phone on infant development
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All vulnerable infants=<2 months old with a history of NICU admission and outpatient admission at the development clinic
Exclusion criteria:
Infants diagnosed with late neurodevelopmental disorders.
Age
To 2 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
According to the order of first visit/admission in developmental clinic, the participants include in random chain and simple randomization is carried out by using a table of random numbers - a large collection of numbers that are generated completely randomly without a specific pattern or order. First, we determine the direction of reading the numbers in the table (for example, up, down, left or right); Then even numbers are assigned to the intervention group and odd numbers to the control group.
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 Tehran University of Medical Sciences
Street address
Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Approval date
2023-06-20, 1402/03/30
Ethics committee reference number
IR.TUMS.IKHC.REC.1402.112
Health conditions studied
1
Description of health condition studied
childhood neurodevelopmental status
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The child's neurodevelopment score in language, cognitive, motor, communication and problem solving areas
Timepoint
0 (before intervention), 4, and 6 months
Method of measurement
by ASQ questionnaire and Baley test
Secondary outcomes
1
Description
child's neurodevelopmental disorder
Timepoint
0 (before intervention), 4, and 6 months
Method of measurement
Prescribing early occupational therapy (before 6 months) and the result of an abnormal Baley test
Intervention groups
1
Description
Intervention group: educational intervention with a mobile phone application (Ati) in parents/caregivers, in addition to the routine training of the evolution clinic, will take place from before the end of the newborn period (28 days) until the end of 6 months. The educational intervention includes sensory-motor, social-emotional and cognitive games appropriate to the child's age.
Category
Behavior
2
Description
Control group: Routine training includes infant massage and targeted games, which are based on the UNICEF (Care for Child Development) protocol and the publications of the Department of Infant Health, and are taught to caregivers by a growth and development specialist.