Performing a massage with the "I love u" technique is three times a day for five consecutive days in the massage group and to perform standard care in the control group. the recorder is not aware of the control and massage group
Settings and conduct
Performing "I Love U"' massage Technique at 8 am , 2 pm and 8 p.m For 15 minutes from the day 6 , the weight measured at 8 am daily,insert oral feeding 6Fr Size, messure of the residual volume of stomach lower than 25 % -50 % of previous nutrition with a 5 ml syringe and a slow aspiration in two times, before the massage and before the meal began , messure abdominal circumference before any massage,begin feeding to 5 – 10 ml/kg/day every 4 to 6 hours and if tolerance feeding occurred, increase meal 140-160ml/kg/day 8 times per day and every3hours. evaluate vomiting and record frequency of defecation
Participants/Inclusion and exclusion criteria
Very low birth weight neonates.Inclusion criteria:the feed of their intestine through the oral tube is also the birth weight of lower than 1500 .Exclusion criteria: abnormal cardiac and digestive system , hypoxic damage , respiratory failure and respiratory support , Necrotizing Entero Colitis (NEC) suspected and Gastroesophageal Reflux (GER) and lavage.
Intervention groups
Group 1 : In the massage group 28 infant receive massage therapy in three times for five consecutive days , group 2: in the control group 28 infants receive standard care.
Main outcome variables
Lavage before and after massage therapy -messure weigh gain and abdominal circomfrence - measurement frequency vomiting and dification
General information
Reason for update
Acronym
MT
IRCT registration information
IRCT registration number:IRCT20180103038205N1
Registration date:2018-01-12, 1396/10/22
Registration timing:retrospective
Last update:2018-01-12, 1396/10/22
Update count:0
Registration date
2018-01-12, 1396/10/22
Registrant information
Name
Mohsen Haghshenas
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3223 8301
Email address
m.haghshenas@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
2016-11-21, 1395/09/01
Actual recruitment end date
2017-11-22, 1396/09/01
Trial completion date
empty
Scientific title
The impact of abdominal massage on infant feeding in very low birth weight admitted in the Neonatal Intensive Care Unit (NICU)
Public title
Massage and feeding tolerance
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
The feed of their intestine through the oral tube is also the birth weight of lower than 1500 g without intestine obstract, abdomen surgery,NEC,contraindication of massage
Exclusion criteria:
Abnormal cardiac and digestive system , hypoxic damage , respiratory failure and respiratory support , NEC suspected and GER and lavage
Age
From 189 days old to 231 days old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
40
In the checklist compiled by the researcher every three hours and during five consecutive days , data related to each sample were recorded
Actual sample size reached:
58
More than 1 sample in each individual
Actual sample size in each individual:
40
In the checklist compiled by the researcher every three hours and during five consecutive days , data related to each sample were recorded
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The recorder is not aware of the control and massage group
Placebo
Used
Assignment
Single
Other design features
Intervention for five consecutive days
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق پزشکی علوم پزشکی بابل
Street address
خیابان گنج افروز،دانشگاه علوم پزشکی بابل
City
Babol
Province
Mazandaran
Postal code
45745-47176
Approval date
2016-11-09, 1395/08/19
Ethics committee reference number
MUBABOL.HRI.REC.1395.52
Health conditions studied
1
Description of health condition studied
The impact of the massage on daily weight gain and decrease gastric residual volume and distention and duration of hospital stay and the number of vomiting of VLBW infant compared to control group that has not received massage.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
massage therapy
Timepoint
every 3 hours ( from 8 a.m. to 5 a.m.next day )
Method of measurement
Observing and recording
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention Group: ' I Love U ' massage Technique at 8 am , 2 pm and 8 p.m For 15 minutes from the day 6 , the weight measure at 8 am daily, insert oral feeding 6Fr Size,messure of the residual volume of stomach lower than 25 % -50 % of previous nutrition with a 5 mm syringe and a slow aspiration in two times, before the massage and before the meal began,messure abdominal circumference before any massage,begin feeding to 5 – 10 ml/kg/day every 4 to 6 hours and if tolerance feeding increase meal 140-160ml/kg/day 8 promises per day and every3hours. evaluate vomiting , record frequency of defecation.
Category
Treatment - Other
2
Description
Control group: Gather information like the intervention group and receive routin care. recorder does not know the control and massage group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rouhani hospital
Full name of responsible person
Mohsen Haghshenas
Street address
Babol university Of medical seinces, University square , Babol
City
Babol
Province
Mazandaran
Postal code
45745-47176
Phone
+98 11 3223 8301
Email
m.haghshenas@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mohsen Haghshenas
Street address
Babol university Of medical seinces, University square , Babol
City
Babol
Province
Mazandaran
Postal code
45745-47176
Phone
+98 11 3223 9301
Email
m.haghshenas@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Hamed
Position
nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Emam Khomeini hospital, Chamran Expressway, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 11 3223 8284
Email
Fatemehamed1348@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mohsen Haghshenas
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Keshavarz Blvd, Rohani hospital
City
babol
Province
Mazandaran
Postal code
45745-47176
Phone
+98 11 3223 8301
Email
m.haghshenas@mubabol.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mohsen Haghshenas
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Keshavarz Blvd, Rouhani hospital
City
Babol
Province
Mazandaran
Postal code
45745-47176
Phone
+98 11 3223 8303
Email
m.haghshenas@mubabol.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
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
No - There is not 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