Investigating the effect of kangaroo mother care (KMC) on the vital signs of preterm infants
Design
Clinical trial with control group, with parallel groups, phase 3 number of 47 infants in each group. Allocation of samples to intervention groups is done by doctor's order
Settings and conduct
This study is conducted on preterm infants born in Qazvin Kosar Hospital. kangaro mother care starts once a day for 24 to 34 minutes and gradually reaches 1 to 3 hours three times a day. Trained mothers hug babies in the fetal position so that the head is placed between the breasts and the baby's chest on the mother's chest, and the head is placed to one side and a little back so that the baby's airway remains open and eye to eye contact is maintained. This is done. All cardiac and respiratory assessments of the infant are performed during continuous cuddling care and if the infant has an order for pulse oximetry. The temperature of the baby is measured before, after and during care according to NICU and neonatal ward protocol as needed. Any distress in the baby is controlled and recorded. The control group does not have KMC due to various reasons such as mothers hospitalized in ICU, sick mothers, death of the mother, distance from the road, etc.
Participants/Inclusion and exclusion criteria
Inclution criteria: All infants aged less than 37 weeks and weighing less than 2500 grams
Exclusion criteria: Instability of the infant's body temperature
Instability of arterial oxygen saturation level
Infant under mechanical ventilation (NCPAP or IMV)
Intervention groups
The intervention group receives kangaro mother care and the control group receives placement in the incubator without hugs
Main outcome variables
Vital signs of preterm infants
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240204060894N1
Registration date:2024-03-16, 1402/12/26
Registration timing:prospective
Last update:2024-03-16, 1402/12/26
Update count:0
Registration date
2024-03-16, 1402/12/26
Registrant information
Name
Marzieh Zarabadi pour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
marziyeeee44@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of kangaroo mother care (KMC) on the vital signs of preterm infants
Public title
Investigating the effect of kangaroo mother care (KMC) on the vital signs of preterm infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All infants who are less than 37 weeks old and weigh less than 2500 grams
Exclusion criteria:
infants under 32 weeks and over 37 weeks
Parents' unwillingness to participate in the study
Instability of the infant's body temperature
Instability of arterial oxygen saturation level
Infant under mechanical ventilation (NCPAP or IMV)
The presence of a venous catheter in the shoulder area due to the possibility of high movement in infants who receive intravenous feeding
Presence of umbilical artery catheter or chest tube of the infant
infants who receive vasopressor and inotrope drugs to regulate blood pressure
Infants prone to intraventricular hemorrhage (IVH)
infants with severe (acute) illnesses or needing special treatment
infants who have suddenly become ill within the past 24 hours
Infants with persistent bradycardia apnea require respiratory stimulation.
Parents with skin lesions or skin ulcers or acute illnesses should delay care until full recovery.
Age
From 1 day old to 28 days old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
47
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 Qazvin University of Medical Sciences
Street address
Research and Technology deputy ,Mavaddat Alley,Shahid Beheshti Blvd,Qazvin
City
Qazvin
Province
Qazvin
Postal code
3413996134
Approval date
2024-01-21, 1402/11/01
Ethics committee reference number
IR.QUMS.REC.1402.342
Health conditions studied
1
Description of health condition studied
Neonatal premature
ICD-10 code
P07.3
ICD-10 code description
Preterm [premature] newborn [other]
Primary outcomes
1
Description
Vital signs of premature infants
Timepoint
Measurement of vital signs before and after cuddling
Method of measurement
Pressure gauge, monitoring, thermometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: kangaroo mother care start once a day for 24 to 34 minutes and gradually reach 1 to 3 hours three times a day. Trained mothers hug infants in the fetal position so that the head is placed between the breasts and the infant's chest on the mother's chest, and the head is placed to one side and slightly back so that the infant's airway remains open and eye contact is established.
Category
Treatment - Other
2
Description
Control group: without hugging. For various reasons, such as mothers hospitalized in the ICU, sick mothers, death of the mother, distance from the road, etc., they do not have KMC and receive routine treatments without hugs.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Hospital
Full name of responsible person
Marzieh Zarabadipour
Street address
Kosar Ave., Taleghani Blvd
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3323 6374
Email
Hoskosar@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Marzieh Zarabadipour
Street address
Research and Technology deputy ,Mavaddat Alley,Shahid Beheshti Blvd
City
Qazvin
Province
Qazvin
Postal code
3413996134
Phone
+98 28 3333 7006
Email
researchdpt@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Marzieh Zarabadipour
Position
intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Bahonar street
City
Qazvin
Province
Qazvin
Postal code
34197-58911
Phone
+98 28 3333 6001
Email
marziyeeee44@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Marzieh Zarabadipour
Position
intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Bahonar street
City
Qazvin
Province
Qazvin
Postal code
34197-58911
Phone
+98 28 3333 6001
Email
marziyeeee44@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Marzieh Zarabadipour
Position
intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
خیابان باهنر
City
Qazvin
Province
Qazvin
Postal code
34197-58911
Phone
+98 28 3333 6001
Email
marziyeeee44@gmail.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