This study is aimed to evaluate the efficacy of tactile stimulation by mother on growth indices in premature neonates.
Design
This clinical trial will be controlled with a parallel group and randomized. Hundred hospitalized premature infants (50 infant in each groups) will be enrolled in this study. participants will be randomized in blocks of 4.
Settings and conduct
This study will be conducted in neonatal and NICU wards of two major hospitals in Mazandaran province (Imam Sajjad Hospital of Ramsar and Shahid Rajjai of Tonekabon). In the beginning of enrollment demographic and clinical data are recorded. Also, throughout the trial respiratory rate, pulse rate, calorie intake and growth indices are recorded in intervals. The 15 minutes massage (tactile stimulation) are divided in 3 five minutes intervals. In first and last phase, neonate is placed in prone position and touched gently with finger pulp of both hands, five determined areas are touched for one minute. In the middle phase, the infant is positioned supine and 6 passive extension-flexion movements (one every 10 seconds) are given in the following five areas: right arm, left arm, right foot, left foot and both legs. The intervention will be performed between 7 a.m and 7 p.m
Participants/Inclusion and exclusion criteria
Neonatal age of 5
Gestational age of less than 37 weeks
Absence of any congenital anomalies
Absence of maternal addiction to alcohol, cigarette and illicit drug
Absence of any surgical intervention in neonate
Absence of feeding anything other than exclusive breast-milk
Intervention groups
In this group, neonates will receive tactile stimulation by their mothers other than standard care. Tactile stimulation will be performed in three separate episodes of 15 minutes during three hours. This regimen is continued for ten consecutive days.
Main outcome variables
Growth parameters in month 1, 2 and 3 after intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200106046027N1
Registration date:2020-02-17, 1398/11/28
Registration timing:prospective
Last update:2020-02-17, 1398/11/28
Update count:0
Registration date
2020-02-17, 1398/11/28
Registrant information
Name
ali siahposht-khachaki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3304 4051
Email address
a.siahposht@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2021-10-23, 1400/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of tactile stimulation of movement by the mother's physical growth of premature infants
Public title
Effect of Touch Therapy on Infant Growth
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
More than 5 days of age
gestational age < 37 weeks
Birth weight between 1000 to 1500 grams
Exclusive breast feeding
Exclusion criteria:
Congenital anomalies
Mother with alcohol, cigarette or drug addiction
Prior history of surgery
Age
From 5 days old to 5 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Neonates are allocated in blocks of 4. Blocks are created by sealedenvelope website.
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 mazandaran University of Medical Sciences
Street address
No. 20, Taleghani Ave.
City
Ramsar
Province
Mazandaran
Postal code
4691786953
Approval date
2017-02-28, 1395/12/10
Ethics committee reference number
IR.MAZUMS.REC.1395.2681
Health conditions studied
1
Description of health condition studied
Prematurity
ICD-10 code
P05
ICD-10 code description
Disorders of newborn related to slow fetal growth and fetal malnutrition
Primary outcomes
1
Description
Head Circumference
Timepoint
at birth, before intervention and 1, 2, 3 month after intervention
Method of measurement
Measuring tape
2
Description
Height
Timepoint
at birth, before intervention and 1, 2, 3 month after intervention
Method of measurement
Measuring tape
3
Description
Weight
Timepoint
at birth, before intervention and 1, 2, 3 month after intervention
Method of measurement
Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Neonates in this group will receive 45 minutes daily massage in addition to standard care. The 45 minutes massage is delivered in three 15 minutes episodes for ten days. The 15 minutes massage are divided into three 5 minutes intervals. In the first and last phase, the neonate is placed in the prone position and touched with finger pulps of both hands. The following five areas are touched every minute: Twelve touch movements (one every 5 seconds) from the tip of the head downward to the face, neck and vice versa. Twelve touch movements (one every 5 seconds) from the back of the neck across the shoulders and vice versa. Twelve Touch movement (one every 5 seconds) from the upper back to the lower back and vice versa. Twelve Touch movement (one every 5 seconds) from the thighs down to the ankle and vice versa. Twelve touch movement (one every 5 seconds) from shoulder to wrist and vice versa. In the middle phase, the neonate is placed in the supine position and six passive extension-flexion movements (one every 10 seconds) are given in the following five areas: Right and left arms, Right foot and left legs, and both feet. The intervention will be performed between 7 a.m and 7 p.m.
Category
Treatment - Other
2
Description
Control group: Control group neonates will receive regular care of the ward.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Sajjad Hospital
Full name of responsible person
Hossein Firouzi
Street address
Shahrdari Sq, Imam Sajjad Hospital
City
Ramsar
Province
Mazandaran
Postal code
46917-14144
Phone
+98 11 5522 2033
Email
firoozihosein@mazums.ac.ir
2
Recruitment center
Name of recruitment center
Shahid Rajjai Hospital
Full name of responsible person
Hossein Firouzi
Street address
Imam Khomeini St, Shahid Rajjai Hospital
City
Tonekabon
Province
Mazandaran
Postal code
4681648183
Phone
+98 11 5423 7001
Email
firoozihosein@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Davood Farzin
Street address
Taleghani Ave, No. 20
City
Ramsar
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 5522 6108
Email
davoodfarzin@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Hossein
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Taleghani Ave, No.20
City
Ramsar
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 5522 6108
Email
firoozi.hosein@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hossein
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Taleghani Ave, No.20
City
Ramsar
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 5522 6108
Email
firoozi.hosein@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ali Siahposht-khachaki
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Valie-Asr Boulevard, Sari, Mazandaran, Iran.
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4051
Fax
+98 11 3322 1626
Email
a.siahposht@mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
Title and more details about the data/document
all collected deidentified data for primary and secondary outcome measures are going to be shared
When the data will become available and for how long
After publishing the study, data are going to be available
To whom data/document is available
Data are going to be available to all researchers and clinician irrespective to their employment sector
Under which criteria data/document could be used
Permission are granted upon request for secondary and meta-analysis
From where data/document is obtainable
Requests are gathered through principle researcher's e-mail address
What processes are involved for a request to access data/document
Upon verification of request and reason data are given in three month.