Objectives: To assess the effect of massage versus no massage on weight gain in low birth weight neonates.
Design: a double blinded randomized clinical trial.
Setting and conduct: The eligible neonates who are admitted in NICU of Fatemieh Hospital during the study period will be enrolled into the trial.
Inclusion criteria: (a) birth weight less than 2400 gr; (b) gestational age between 25 to 34 weeks; (c) stability of the clinical condition of the neonate based on the neonatologist decision; (d) beginning of breastfeeding.
Exclusion criteria: (a) age of lower than 5 days; (b) presence of genetic disorder, congenital cardiomyopathy, central nerves system disorder, intra-ventricular hemorrhage; (c) history of maternal drug abuse.
Intervention: massage for 15 min three times a day for 5 days including reciprocating touch of the top area of the head to the neck, from neck to shoulders, shoulder to hand, back to waist, thigh to ankle in a prone position and then flexion and extension movements of the arms and legs in the supine position.
Control: inpatient neonates without massage.
Primary outcome: (a) measuring weight daily for 5 days using the meter; (b) measuring height daily for 5 days using weight scale; (c) measuring head circumference daily for 5 days using the meter.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201411189014N47
Registration date:2014-11-30, 1393/09/09
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-11-30, 1393/09/09
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-08-22, 1394/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of massage versus no massage on weight gain in low birth weight neonates: a double blinded randomized clinical trial
Public title
Effect of massage versus no massage on weight gain in low birth weight neonates
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) birth weight less than 2400 gr; (b) gestational age between 25 to 34 weeks; (c) stability of the clinical condition of the neonate based on the neonatologist decision; (d) beginning of breastfeeding.
Exclusion criteria: (a) age of lower than 5 days; (b) presence of genetic disorder, congenital cardiomyopathy, central nerves system disorder, intra-ventricular hemorrhage; (c) history of maternal drug abuse.
Age
From 5 days old to 28 days old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: random assignment of the neonates schematically one at a time to intervention and control groups.
Blinding: Babies do not have sufficient understanding and have no effect on the outcomes of interest. In addition, the examiner who will examine the neonates is another person that will not be aware of the type of intervention. Therefore, the trial will be run as double blinded.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2014-10-16, 1393/07/24
Ethics committee reference number
P/16/35/9/3456
Health conditions studied
1
Description of health condition studied
low birth weight
ICD-10 code
P07.1
ICD-10 code description
Other low birth weight
Primary outcomes
1
Description
measuring weight
Timepoint
daily for 5 days
Method of measurement
using the meter
2
Description
measuring height
Timepoint
daily for 5 days
Method of measurement
using weight scale
3
Description
measuring head circumference
Timepoint
daily for 5 days
Method of measurement
using the meter
Secondary outcomes
1
Description
nothing
Timepoint
nothing
Method of measurement
nothing
Intervention groups
1
Description
inpatient neonates without massage
Category
Other
2
Description
: massage for 15 min three times a day for 5 days including reciprocating touch of the top area of the head to the neck, from neck to shoulders, shoulder to hand, back to waist, thigh to ankle in a prone position and then flexion and extension movements of the arms and legs in the supine position.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Sahar Johari
Street address
Fatemieh Hospital, Pasdaran Ave
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Department of Speech Therapy, School of Rehabilitation Sciences, Hamadan University of Medical Scien
Full name of responsible person
Sahar Johari
Position
Speech therapists
Other areas of specialty/work
Street address
Department of Speech Therapy, School of Rehabilitation Sciences, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3838 0572
Fax
Email
saharjohari85@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Speech Therapy, School of Rehabilitation Sciences, Hamadan University of Medical Scien
Full name of responsible person
Mostafa Daemi
Position
Speech therapists
Other areas of specialty/work
Street address
Department of Speech Therapy, School of Rehabilitation Sciences, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3838 0572
Fax
Email
daemist@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)