Investigating the effect of abdominal massage on the residual gastric volume and physiological responses in hospitalized preterm infants in neonatal intensive care unit
Investigating the effect of abdominal massage on the residual gastric volume and physiological responses in preterm infants
Design
Clinical trial with parallel control group, without blinding
Settings and conduct
The researcher will refer to Ali ebn Abitaleb hospital of Rafsanjan and then the sample according to inclusion criteria will be divided to two groups. Intervention will perform twice a day . Gastric residual volume and physiological responses of newborns before and after intervention are measured and recorded.
Participants/Inclusion and exclusion criteria
30 to 34 weeks of gestational age; lack of congenital anomalies and abdominal defects; no need to mechanical ventilation
Intervention groups
Intervention group: abdominal massage will be used for 15 minutes, twice a day and for a 5 days period. Gastric residual volume and physiological responses of newborns before and after intervention are measured and recorded.
Control group: just will receive routine care.Gastric residual volume and physiological responses of newborns before and after intervention are measured and recorded.
Main outcome variables
Physiological responses; gastric residual volume
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180913041030N1
Registration date:2019-03-05, 1397/12/14
Registration timing:prospective
Last update:2019-03-05, 1397/12/14
Update count:0
Registration date
2019-03-05, 1397/12/14
Registrant information
Name
Roghayeh Mehdipour Rabori
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5220
Email address
r_mehdipour@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-06, 1397/12/15
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of abdominal massage on the residual gastric volume and physiological responses in hospitalized preterm infants in neonatal intensive care unit
Public title
Investigating the effect of abdominal massage on the residual gastric volume and physiological responses in preterm infants
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
30 to 34 weeks of gestational age
Feeding through nasogastric tube
No need to mechanical ventilation
Exclusion criteria:
Abdominal defects and congenital anomalies
Prohibition of massage in order to physician opinion
Feeding intolerance
Age
From 1 day old to 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The sample will be selected from preterm infants according to inclusion criteria,then by using of sortition, infants will be placed in two equal groups
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 Kerman University of Medical Sciences
Street address
Campus of Kerman medical science university,Haft-Bagh Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2019-01-29, 1397/11/09
Ethics committee reference number
IR.KMU.REC.1397.413
Health conditions studied
1
Description of health condition studied
Physiological responses
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Gastric residual volume
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Arterial oxygen saturation
Timepoint
Before and after intervention
Method of measurement
Pulseoximetery
2
Description
Heart rate
Timepoint
Before and after intervention
Method of measurement
Pulseoximetery
3
Description
Gastric residual volume
Timepoint
Before and after intervention
Method of measurement
Measurement of residual volume with syringe
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: abdominal massage will be used for 15 minutes, twice a day and for a 5 days period. Gastric residual volume and physiological responses of newborns before and after intervention are measured and recorded.
Category
Other
2
Description
Control group: just will receive routine care.Gastric residual volume and physiological responses of newborns before and after intervention are measured and recorded.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali ebn abitaleb hospital
Full name of responsible person
Azadeh Moghadam
Street address
Hazrat Ali ebn Abitaleb hospital, Mofateh Blvd.,
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0001
Fax
+98 34 3428 0022
Email
aliebn@rums.ac.ir
Web page address
www.http://aliebn.rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Reza Dehnaviyeh
Street address
Kerman medical sciences university, Haft Bagh highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5402
Fax
+98 34 3132 5856
Email
rdehnavi@gmail.com
Web page address
http://kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Roghayeh Mehdipour Rabori
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Haft Bagh Alavi Ave, Nursing Department, Kerman Medical University,
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5220
Fax
Email
r_mehdipour@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Roghayeh Mehdipour Rabori
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Haft Bagh Alavi Ave, Nursing Department, Kerman Medical University,
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5220
Fax
Email
r_mehdipour@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Roghayeh Mehdipour Rabori
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Haft Bagh Alavi Ave, Nursing Department, Kerman Medical University,
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5220
Fax
Email
r_mehdipour@kmu.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