Determining the effect of developmental care on cognitive function and quality of life of preterm born children at school age.
Design
Clinical trial study with control group, with parallel group design, non random, not blinded on 70 neonate.
Settings and conduct
This research is an interventional study with 2 study groups and 35 neonates in each group, which will be conducted on babies whose gestational age is 26 to 32 weeks and who were hospitalized in the neonatal intensive care unit of Alzahra Hospital of Tabriz, for at least 24 hours. For the intervention group, developmental care was done in the neonatal intensive care unit and the neonatal unit, and the control group received routine care. The investigated outcomes include the cognitive performance and quality of life of these infants at school-age .
Participants/Inclusion and exclusion criteria
Inclusion criteria: The tendency of parents to participate in the study; Gestational age equal or less than 32 weeks; Lack of maternal use of alcohol or drugs during pregnancy; hospitalization in Intensive Care Unit for at least 24 hours.
Exclusion criteria: Chromosomal abnormalities and congenital anomalies; Severe congenital infections; Infants need surgery; Inappropriate weight for gestational age at birth.
Intervention groups
Intervention group's infants will be received developmental care that includes the reducing light, reducing environment noise, nesting, manipulating of infants with slow movements, etc in NICU.
Control group's infants will be received routine care.
Main outcome variables
Cognitive function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111219008459N17
Registration date:2024-05-25, 1403/03/05
Registration timing:prospective
Last update:2024-05-25, 1403/03/05
Update count:0
Registration date
2024-05-25, 1403/03/05
Registrant information
Name
Shirin Hasanpoor
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
hasanpoorsh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of developmental care on cognitive function and quality of life of preterm born children at school age
Public title
The effectiveness of developmental care on cognition and quality of life of preterm born children at school age
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The tendency of parents to participate in the study
Gestational age equal or less than 32 weeks
Lack of maternal use of alcohol or drugs during pregnancy
Hospitalization in Neonatal Intensive Care Unit for at least 24 hours
Exclusion criteria:
Chromosomal abnormalities and congenital anomalies
Severe congenital infections
Infants need surgery
Inappropriate weight for gestational age at birth
Age
From 6 months old to 7 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
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
Ethic's committee of Tabriz University of Medical Sciences
Street address
Physical Medicine and Rehabilitation Research Center, Imam Reza Hospital,Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Approval date
2024-04-15, 1403/01/27
Ethics committee reference number
IR.TBZMED.REC.1403.033
Health conditions studied
1
Description of health condition studied
Cognitive performance and quality of life of children.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Cognitive performance
Timepoint
School age
Method of measurement
Using of PedsQL 3.0 Cognitive Functioning Scale
Secondary outcomes
1
Description
Quality of Life
Timepoint
School age
Method of measurement
Using of Pediatrics Quality of Life Scale
Intervention groups
1
Description
Intervention group: Infants in this group(35 infant) will be received developmental care that includes the reducing light, reducing environment noise, nesting, manipulating of infants with slow movements, etc in Neonatal Intensive Care Unit and neonatal ward.
Category
Prevention
2
Description
Control group: Infants in this group(35 infant) will be received routine care.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital of Tabriz
Full name of responsible person
Shirin Hasanpour
Street address
Physical Medicine and Rehabilitation Research Center, Imam Reza Hospital,Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3382 3660
Email
shirinhasanpoor@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5168743953
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Shirin Hasanpour
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Physical Medicine and Rehabilitation Research Center, Imam Reza Hospital,Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2081
Email
shirinhasanpoor@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Shirin Hasanpour
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Physical Medicine and Rehabilitation Research Center, Imam Reza Hospital,Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2081
Email
shirinhasanpoor@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Shirin Hasanpour
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Physical Medicine and Rehabilitation Research Center, Imam Reza Hospital,Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2081
Email
shirinhasanpoor@yahoo.com
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