Determining the effect of kangaroo care on delirium in neonates under non-invasive mechanical ventilation
Design
Two arm parallel group randomised trial, with total sample size of 50 infants.
Settings and conduct
The neonatal intensive care units of the three hospitals of the Children's Medical Center, Bahrami and Shariati will be the place of study.Infants are randomly assigned to the intervention and control groups based on the start date of non-invasive mechanical ventilation.Evaluation of both intervention and control groups for delirium during the study period is performed using the Cornell Assessment of Pediatric Delirium (CAPD) at 7 p.m. by researcher or caregiver based on documentation and observations.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Being under non-invasive mechanical ventilation
The corrected age of the infant at the time of enrollment (initiation of non-invasive mechanical ventilation) should be 35 weeks gestational age (after fertilization)
Not being treated with sedatives and anticonvulsants
Exclusion criteria:
Convulsion and followed that taking anticonvulsants as well as starting sedatives
Exposure to non-invasive mechanical ventilation for less than 72 hours
Dissatisfaction of the neonate guardian to enter the study
Initiation of invasive mechanical ventilation
Intervention groups
Kangaroo care by skin-to-skin contact between mother and infant (at least 30 minutes a day) is the intervention of this study. The study outcome will then be compared with the control group, who received routine care.
Main outcome variables
Score of Cornell Assessment of Pediatric Delirium (CAPD) questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201130049544N1
Registration date:2021-06-19, 1400/03/29
Registration timing:prospective
Last update:2021-06-19, 1400/03/29
Update count:0
Registration date
2021-06-19, 1400/03/29
Registrant information
Name
Nasim Mirzaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6617 9674
Email address
nmirzaeis@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of Kangaroo care on Delirium in Neonates under Non-Invasive mechanical Ventilation
Public title
Investigating the effects of Kangaroo care on Delirium in Neonates under Non-Invasive mechanical Ventilation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Being under non-invasive mechanical ventilation
The corrected age of the neonate at the time of enrollment (initiation of non-invasive mechanical ventilation) should be 35 weeks gestational age (after fertilization)
Not being treated with sedatives and anticonvulsants
Exclusion criteria:
convulsion and followed that taking anticonvulsants as well as starting sedatives
Exposure to non-invasive mechanical ventilation for less than 72 hours
Dissatisfaction and unwillingness of the neonate guardian to enter the study
Initiation of invasive mechanical ventilation
Age
To 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
After entering the study, the samples are assigned to the intervention and control groups based on the start date of non-invasive mechanical ventilation. In this case, if the sample is included in the study on the odd date , it is placed in the intervention group, and if it is included in the study on the even date, it is placed in the control group. If several samples meet the entry requirements on a date, they will be entered into each intervention or control group based on a lottery.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, the samples are randomly assigned to two groups of intervention and control. The intervention group will receive kangaroo care intervention (for at least 30 minutes a day) based on the study protocol and will eventually be compared to the control group that received routine care.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research, School of Nursing, Midwifery and Rehabilitation, Tehran University of
Street address
Unit. 5, No 52, Toos St, Ghasredasht St, Azarbaijan Ave, Jomhouri Squ
City
Tehran
Province
Tehran
Postal code
1345967880
Approval date
2021-01-18, 1399/10/29
Ethics committee reference number
IR.TUMS.FNM.REC.1399.181
Health conditions studied
1
Description of health condition studied
delirium
ICD-10 code
F06.8
ICD-10 code description
Other specified mental disorders due to known physiological condition
Primary outcomes
1
Description
Score of Cornell Assessment of Pediatric Delirium (CAPD) questionnaire
Timepoint
Evaluation of both intervention and control groups for delirium during the study period is performed using the Cornell Assessment of Pediatric Delirium (CAPD) at 7 p.m. daily by researcher or caregiver based on documentation and observations.
Method of measurement
Cornell Assessment of Pediatric Delirium (CAPD) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This study is performed on neonates who have reached at least 35 weeks of gestation when non-invasive mechanical ventilation begins. If the baby is born full-time, the maximum time he/she can enter the study is up to 28 days after birth (end of the neonatal period), and if the baby is born pre-term, his/her corrected age is (41 weeks after fertilization) is considered as the maximum time allowed to enter the study. Intervention in the present study, kangaroo care will be in the form of skin-to-skin contact between mother and baby. The minimum duration of skin-to-skin contact is 30 minutes (24 hours a day), which can be intermittent or continuous. The study outcome will then be compared with the control group, who received routine care.
Category
Behavior
2
Description
Control group: The control group in this study will receive routine care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Nasim Mirzaei Salout
Street address
Unit. 5, No 52, Toos St, Ghasredasht St, Azarbaijan Ave, Jomhouri Squ
City
Tehran
Province
Tehran
Postal code
1345967880
Phone
+98 21 6617 9674
Email
nasim_mirzaei14@yahoo.com
2
Recruitment center
Name of recruitment center
Children's Medical Center hospital
Full name of responsible person
Nasim Mirzaei Salout
Street address
Unit. 5, No 52, Toos St, Ghasredasht St, Azarbaijan Ave, Jomhouri Squ
City
Tehran
Province
Tehran
Postal code
1345967880
Phone
+98 21 6617 9674
Email
nasim_mirzaei14@yahoo.com
3
Recruitment center
Name of recruitment center
Bahrami Children Hospital
Full name of responsible person
Nasim Mirzaei Salout
Street address
Unit. 5, No 52, Toos St, Ghasredasht St, Azarbaijan Ave, Jomhouri Squ
City
Tehran
Province
Tehran
Postal code
1345967880
Phone
+98 21 6617 9674
Email
nasim_mirzaei14@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mehrnaz Geranmay
Street address
Unit. 5, No 52, Toos St, Ghasredasht St, Azarbaijan Ave, Jomhouri Squ
City
Tehran
Province
Tehran
Postal code
1345967880
Phone
+98 21 6617 9674
Email
nasim_mirzaei14@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Nasim Mirzaei Salout
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit. 5, No 52, Toos St, Ghasredasht St, Azarbaijan Ave, Jomhouri Squ
City
Tehran
Province
Tehran
Postal code
1345967880
Phone
+98 21 6617 9674
Email
nasim_mirzaei14@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nasim Mirzaei Salout
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit. 5, No 52, Toos St, Ghasredasht St, Azarbaijan Ave, Jomhouri Squ
City
Tehran
Province
Tehran
Postal code
1345967880
Phone
+98 21 6617 9674
Email
nasim_mirzaei14@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nasim Mirzaei Salout
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit. 5, No 52, Toos St, Ghasredasht St, Azarbaijan Ave, Jomhouri Squ
City
Tehran
Province
Tehran
Postal code
1345967880
Phone
+98 21 6617 9674
Email
nasim_mirzaei14@yahoo.com
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