This study aimed to evaluate the effect of massage on weight gain in very low birth weight neonates. Inclusion criteria include birth weight between 1000-1500 gr; appropriate weight for gestational age; oral milk feeding and no parenteral nutrition dependency; no substance abuse by mother during pregnancy; infant without congenital diseases or disorder in central nervous system. Exclusion criteria: respiratory distress and receive oxygen support; gastrointestinal disorder such as vomiting or milk intolerance; photo therapy and TORCH syndrome. 40 neonates with 1000-1500 gr birth weight are selected according to inclusion and exclusion criteria by non-random sampling and will randomly be assigned to two groups as control and intervention, 20 member in each group. Study period is from 20.3.2012 until 20.2.2015. The control group will receive usual care for premature newborns. The intervention group will receive massage therapy for one week, three times per day, duration of each time was 15 min, at least 4 hrs. interval. They will treated by the researcher under the supervision of physiotherapist. At the start and the end of study information about growth monitoring include (weight, high and head circumference) will be measured. Primary outcome: weight bearing after one week.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014092019232N1
Registration date:2014-12-09, 1393/09/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-09, 1393/09/18
Registrant information
Name
Fahimeh Kazemian Baboli
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3538 2160
Email address
f.kazemian@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Non Communicable Diseases in Children Research Center, Babol University of Medical Sciences
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of massage on weight gain in very low birth weight neonates
Public title
Effect of massage on newborn weight gain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: birth weight 1000 - 1500 gr; appropriate for gestational age; breast feeding and no need for parenteral nutrition; physical stability; lake of maternal drug abuse in pregnancy; infants without congenital anomalies and CNS disorders; permit professor of infants and consent of the parents
Exclusion criteria: respiratory distress and receive oxygen support; GI problems such as vomiting and milk intolerance; infant that need surgery; photo therapy and blood transplantation; TORCH syndrome
Age
From 7 years old to 1 month old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Keshavarz Street, Babol
City
Babol
Postal code
47976-47745
Approval date
2013-10-12, 1392/07/20
Ethics committee reference number
9236622
Health conditions studied
1
Description of health condition studied
low birth weight newborn
ICD-10 code
P07.14
ICD-10 code description
Other low birth weight newborn, 1000-1249 gr
2
Description of health condition studied
Low birth weight newborn
ICD-10 code
P07.15
ICD-10 code description
Other low birth weight newborn, 1250-1499 gr
Primary outcomes
1
Description
weight
Timepoint
At baseline and at the end of the first week
Method of measurement
with balance
Secondary outcomes
1
Description
Height
Timepoint
At baseline and at the end of the first week
Method of measurement
With Meter
2
Description
Head circumference
Timepoint
At baseline and at the end of the first week
Method of measurement
With meter
Intervention groups
1
Description
Usual care for premature newborns. at the end of study growth monitoring will be done for them.
Category
Treatment - Other
2
Description
Massage therapy sessions will be done 15 minutes long fourth daily for one week. All sessions will be done with researcher under supervision of physiotherapist. at the end of study growth monitoring will be done for them.