Protocol summary

Study aim
Determining and comparing the method of tactile-kinetic stimulation and maternal kangaroo care on weight gain in infants of late prematurity admitted to the neonatal intensive care unit.
Design
A randomized clinical trial with the control group, with intervention and control groups, on 80 infants of late prematurity admitted to the neonatal intensive care unit
Settings and conduct
The study site of the neonatal intensive care unit of Ayatollah Mousavi Hospital in Zanjan is affiliated to Zanjan University of Medical Sciences
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Fetal age 37-34 weeks 2. Hemodynamic stability 3. Nutrition through digestion (oral or digestive tube) with breast milk or formula 4. Staying in the neonatal intensive care unit for at least one week 5. The birth of an only child 6. Iranian nationality 7. The presence of the biological mother, who is literate and willing and able to perform interventions correctly in the hospital Exclusion criteria: 1. Having a diagnosis of genetic, cardiac, respiratory, central nervous system problems (acquired and congenital) 2. The need for any surgery 3. Having a history of intrauterine growth retardation 4. History of substance abuse in the mother
Intervention groups
30 babies in the control group and 30 babies in the intervention group with tactile stimulation. and 30 babies will be in the intervention group with mother's kangaroo care. These interventions will be performed three times a day for 60 minutes in the kangaroo mother care group and 15 minutes in the tactile-kinetic stimulation group for one week.
Main outcome variables
In case of the positive effect of the studied interventions on the weight of infants in late prematurity, training to use these methods as auxiliary interventions in weight gain of these infants.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210109049974N1
Registration date: 2023-02-11, 1401/11/22
Registration timing: retrospective

Last update: 2023-02-11, 1401/11/22
Update count: 0
Registration date
2023-02-11, 1401/11/22
Registrant information
Name
Soheila Mirlou
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3352 9480
Email address
mirlous@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2021-10-22, 1400/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of kangaroo mother care and tactile-kinesthetic stimulation on weight gain of late preterm infants in hospitalized in neonatal intensive care units in the Mousavi hospital affiliated to Zanjan University of Medical Sciences. 2020. :A Randomized Clinical Trial.
Public title
Comparison of kangaroo mother care and tactile-kinesthetic stimulation on weight gain of late preterm infants in hospitalized in neonatal intensive care units.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Fetal age 34-37 weeks Hemodynamic stability Feeding through the digestive system (oral or digestive tube) with breast milk or formula Staying in the neonatal intensive care unit for at least one week Birth of a singleton Iranian nationality The presence of the biological mother, who is literate and willing and able to perform interventions correctly in the hospital
Exclusion criteria:
Discharge the baby before the end of the intervention Transfer to another department before the end of the intervention Having a diagnosis of genetic, cardiac, respiratory, central nervous system problems (acquired and congenital) The need for any surgery Having a history of intrauterine growth retardation History of substance abuse in the mother
Age
From 238 days old to 259 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
The function of random numbers was used to randomize and assign people to groups; Randomization using Excel software is as follows: First, in one column, the groups are entered as A, B, c and below; Because the number of samples in each group is set to 30 (including sample loss), therefore, 30, B, A c should be entered in order. In the opposite column, random numbers are generated using the RAND command. In the next step, using the sort command, the generated random numbers are sorted from small to large or vice versa, which changes the order of the groups, i.e. c A, B. Using the new order, people are assigned to different groups.
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 Shahid Beheshti University of Medical Sciences
Street address
no.3,7th floor,block6,The residential complex of Farhang Town sepehr,
City
Zanjan
Province
Zanjan
Postal code
4519949858
Approval date
2020-11-15, 1399/08/25
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.696

Health conditions studied

1

Description of health condition studied
Maternal kangaroo care and kinetic tactile stimulation
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Weight
Timepoint
Before study, during study, after study
Method of measurement
Digital baby measuring scales

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group: in the tactile-kinetic stimulation intervention group, late preterm infants will receive tactile-kinetic stimulation three times a day (morning, noon, night) for 15 minutes for 7 days. This intervention will be performed by mothers on babies in three 5-minute stages. The stages of the intervention will be as follows:- The first stage: (touch stage) which was done in the palm position and relatively strong tactile stimuli applied by the palms of the baby's mother on the baby's head, neck, shoulders and back It was found that these stimulations lasted for 5 seconds in each turn of tactile stimulation and the duration of this stage was 5 minutes. The firmness that is applied by the palms of the baby's mother on the forehead, cheeks, chest, abdomen, upper and lower limbs, palms and feet of the baby. This stage should last 5 minutes. The third stage: (Kinetic stage) This stage of tactile stimulation will be done in the open arch position and includes passive movements of bending and straightening the upper limbs in the shoulder and elbow joints and the lower limbs in It is the location of the hip, knee and ankle joints. These passive movements will be performed 5 times in each joint, each movement will last 2 seconds and the total time for this step will be 5 minutes.
Category
Other

2

Description
The second intervention group: In the mother's kangaroo care intervention group, the late preterm babies will be placed on the mother's chest by the relevant nurse for 7 days and 3 times a day for 60 minutes, and there will be skin contact between the mother and the baby. The nude that is in a stable physiological condition will be established.
Category
Other

3

Description
Control group: In this research, the control group will be late premature babies who are hospitalized in the neonatal intensive care unit and receive the usual nursing interventions.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mousavi Hospital affiliated to Zanjan University of Medical Sciences
Full name of responsible person
Soheila Mirloo
Street address
Gavazang Road, Ayatollah Mousavi Hospital
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Fax
+98 24 3313 1203
Email
mirlous08@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahmoud Khodadoost
Street address
Chamran Highway, Yemen St., Parvaneh St., next to Taleghani Hospital, Shahid Beheshti University of Medical Sciences and Health Services, Building No. 1, Fifth Floor, Deputy of Management and Resources Development
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9890
Fax
+98 21 2243 9894
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Soheila Mirloo
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Alley of culture, Sepehr residential complex, phase 2, block 6, 7th floor, unit 3
City
Zanjan
Province
Zanjan
Postal code
4519949858
Phone
+98 24 3352 9480
Email
mirlous08@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Lida Nick Farid
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tehran - Vali Asr St. - Niayesh Intersection - in front of Shahid Rajaei Heart Hospital - School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
l.nikfarid@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Soheila Mirlou
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Rose St. 3. Plot 1561/1
City
Zanjan
Province
Zanjan
Postal code
4519949858
Phone
+98 24 3352 9480
Fax
Email
mirlous@sbmu.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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