Protocol summary

Summary
The aim of this study was to investigate the effects of massage on weight gain of premature infants in Imam Khomeini Hospital in 2012 -2013. Inclusion criteria: All of prematurity and parental consent and exclusion: infants need to have surgery or respiratory support-infant have anomaly- congenital heart malformation-central nervous system dysfunction- infants are not able to feed orally. This study includes 34 cases that divided on 2 groups of 17 infants under 36 weeks and was weighing less than 1500 gram thus during the study period was 15 days, 3 times daily, 15 minutes massage one hour after each feeding by massage therapists were trained on the intervention group. To ensure validity and avoid mistakes, each infant had different massage therapists not a fixed massage therapists. At the end of the study the rate of weight gain, the amount of calories and number of infants had ability to breast feeding have been studied and two groups are compared

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201208059568N2
Registration date: 2012-11-21, 1391/09/01
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-11-21, 1391/09/01
Registrant information
Name
Golnaz Rezaeizadeh
Name of organization / entity
Maternal Fetal Neonatal Research Center,Tehran University of Medical Sciences, Tehran, Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2357
Email address
mfnhrc@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of massage on weight gain in premature infants at Imam Khomeini Hospital in 1389
Public title
Neonatal massage effect on weight gain
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion: All premature infants, written consent of the parents Exclusion: infants need to have surgery or respiratory support-infant have anomaly- congenital heart malformation-central nervous system dysfunction-NPO infants
Age
From 33 years old to 36 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 34
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
Maternal Fetal Neonatal Research Center, Tehran University of Medical Sciences, Tehran, Iran
Street address
Ethics committee of Tehran University of Medical Sciences, 6 th floor of Tehran University of Medical Sciences, ghods St., Keshavarz blv, Tehran, Iran
City
Tehran
Postal code
89-03-91-11478
Approval date
2010-11-09, 1389/08/18
Ethics committee reference number
89-03-91-11478

Health conditions studied

1

Description of health condition studied
prematurity
ICD-10 code
p07.3
ICD-10 code description
other preterm infants

Primary outcomes

1

Description
Weight gain of infants
Timepoint
Daily during the intervention
Method of measurement
Balance

2

Description
amount of feeding
Timepoint
daily during the study
Method of measurement
A Questionnaire used infant the amount of milk in 24 hours is a registered CC.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention: massage, one hour after a meal, for 15 days, 3 times daily for 15 minutes
Category
Other

2

Description
Control group: infantss who are not massaged.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Samaneh Sedghi
Street address
Vaiasr hospital, Imam Khomeini Hospital complexex, Keshavarz blv,14914, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Maternal Fetal Neonatal Research Center, Tehran University of Medical Sciences
Full name of responsible person
Mamak Shariat
Street address
Vaiasr hospital, Imam Khomeini Hospital complexex, Keshavarz blv, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Maternal Fetal Neonatal Research Center, Tehran 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
Maternal Fetal Neonatal Research Center, Tehran University of Medical Sciences, Tehran, Iran
Full name of responsible person
Samaneh Sedghi
Position
Researcher/ MD
Other areas of specialty/work
Street address
Vaiasr hospital, Imam Khomeini Hospital complexex, Keshavarz blv, Tehran, Iran
City
Tehran
Postal code
14197
Phone
+98 21 6659 1316
Fax
+98 21 6659 1315
Email
samanesedghi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Maternal Fetal Neonatal Research Center, Tehran University of Medical Sciences
Full name of responsible person
Elahe Amini
Position
Professor/ Neonatologist
Other areas of specialty/work
Street address
Vaiasr hospital, Imam Khomeini Hospital complexex, Keshavarz blv, Tehran, Iran
City
Tehran
Postal code
14197
Phone
+98 21 6659 1316
Fax
+98 21 6659 1315
Email
amini-el88@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Maternal Fetal Neonatal Research Center, Tehran University of Medical Sciences
Full name of responsible person
Samaneh Sedghi
Position
Researcher/MD
Other areas of specialty/work
Street address
Vaiasr hospital, Imam Khomeini Hospital complexex, Keshavarz blv, Tehran, Iran
City
Tehran
Postal code
14197
Phone
+98 21 6659 1316
Fax
+98 21 6659 1315
Email
samanesedghi@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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