The aim of this study is to investigate the effect of body position on the gastric residual volume in preterm neonates.
Inclusion criteria includes feeding through nasogastric or orogastric tube, feeding by breast milk, not attached to the ventilator. Exclusion criteria includes increase in respiratory distress after breast feeding.
Study population: premature neonates hospitalized in neonatal intensive care unit.
Sample size: 135
Intervention: Using the lottery Patients are placed in three groups. Patients in each group are placed in supine, prone, and right side positions for an hour. The sort orders of positions are as below: first group: supine, right side and prone; second group: right side, supine and prone; and third group: prone, supine and right side. In every position, at first, gastric residual volume is measured and then breastfeeding will be start through gavage. After one hour, the gastric residual volume is measured again.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201404134736N6
Registration date:2016-01-31, 1394/11/11
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-01-31, 1394/11/11
Registrant information
Name
Alireza Khatony
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3827 9394
Email address
akhatony@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of body position on the gastric residual volume in preterm neonates admitted to the NICU of Imam Reza Hospital (AS) in 2016
Public title
The effect of body position on the gastric residual volume in preterm neonates
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: gestational age between 30 and 36 weeks; feeding through nasogastric- or orogastric tube; feeding by breast milk; not attached to the ventilator; stable vital signs; Lack of congenital defects.
Exclusion criteria: neonate death during the study; an increase in respiratory distress after breast feeding; unstable vital signs.
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:
135
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Comitee of Kermanshah University of Medical Sciences
Street address
kermanshah University of Medical Sciences, Shahid Beheshty Blvd., Kermanshah
City
Kermanshah
Postal code
Approval date
2015-12-28, 1394/10/07
Ethics committee reference number
kums.rec.1394.279
Health conditions studied
1
Description of health condition studied
preterm neonate
ICD-10 code
P78.9
ICD-10 code description
Perinatal digestive system disorder, unspecified
Primary outcomes
1
Description
gastric residual volume
Timepoint
one hour after milk gavage
Method of measurement
Measurement of gastric residual through the lavage of gastic content
Secondary outcomes
empty
Intervention groups
1
Description
The Patients in first group are placed in supine, right side and prone for an hour. In every position, at first, gastric residual volume is measured and then breastfeeding will be start through gavage. After one hour, the gastric residual volume is measured again.
Category
Prevention
2
Description
The Patients in second group are placed in right side, supine and prone for an hour. In every position, at first, gastric residual volume is measured and then breastfeeding will be start through gavage. After one hour, the gastric residual volume is measured again.
Category
Prevention
3
Description
The Patients in third group are placed in prone, supine and right side for an hour. In every position, at first, gastric residual volume is measured and then breastfeeding will be start through gavage. After one hour, the gastric residual volume is measured again.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Alireza Khatony
Street address
kermanshah University of Medical Sciences, Shahid Beheshty Blvd., Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Behrooz Hamzeh
Street address
kermanshah University of Medical Sciences, Shahid Beheshty Blvd., Kermanshah
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Alireza Khatony
Position
PhD
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences, Shahid Beheshty Blvd., Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3828 2102
Fax
Email
akhatony@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Alireza Khatony
Position
PhD
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences, Shahid Beheshty Blvd., Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3828 2102
Fax
Email
akhatony@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Alireza Khatony
Position
Other areas of specialty/work
Street address
kermanshah University of Medical Sciences, Shahid Beheshty Blvd., Kermanshah
City
Postal code
Phone
+98 83 3828 2102
Fax
Email
Akhatony@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)