The purpose of this study was to evaluate the effect of body position on gastric residual volume in preterm infants. This was a single blind study, so that the researchers were not blind but the executive nurse was blind. In this study, 100 infants aged under 32 weeks with weight between 750-1500 g were randomly divided into two groups. The first group were laid in right lateral position first and then put at prone position. Then Gastric residuals were measured at 1 and 2 hours after initiation of feeding. The infant in second group were laid in prone position first and then put at right lateral position. Gastric residuals were measured at 1 and 2 hours after initiation of feeding. Finally, gastric residuals were compared in both groups. The amount of gastric residual volumes was considered one and two hours after gavages as the primary outcome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201008234617N1
Registration date:2011-11-08, 1390/08/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-11-08, 1390/08/17
Registrant information
Name
Mahnaz Jabraeili
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
jabraeilim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research, Tabriz University of Medical Sciences
Expected recruitment start date
2008-05-05, 1387/02/16
Expected recruitment end date
2008-10-04, 1387/07/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Body position on gastric residual in preterm infant
Public title
Effect of Body position on gastric residual
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: infants' age less than 32weeks; Infant can tolerate stomach tube; weight between 750-1500 gm; clinically stable Infants; breast-feeding during the study and Infants is without congenital anomalies
Exclusion criteria: vomiting during the tests; respiratory distress; abdominal distension and refrain from further testing
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences Ethics Committee
Street address
Deputy of Research, Tabriz University of Medical Sciences ,Golgasht street , Tabriz
City
Tabriz
Postal code
977-5138947
Approval date
2008-02-10, 1386/11/21
Ethics committee reference number
10779/4/5
Health conditions studied
1
Description of health condition studied
gastric residual volume
ICD-10 code
Z00-Z99
ICD-10 code description
Health supervision and care of other healthy infant and child
Primary outcomes
1
Description
Gastric residual volume
Timepoint
One and two hours after gavage
Method of measurement
Using a syringe
Secondary outcomes
empty
Intervention groups
1
Description
The infant of first group, at first gavages were laid in right lateral position and then prone position. Then Gastric residuals were measured at 1 and 2 hours after initiation of feeding
Category
Prevention
2
Description
The infant of second group, at first gavages were laid in prone position and then right lateral position and Gastric residuals were measured at 1 and 2 hours after initiation of feeding
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Educational Center Affiliated Medical Sciences of Tabriz;Iran
Full name of responsible person
Mrs Ashorian & Ataeeyan
Street address
Bagshomal Square;Tabriz;Iran
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of research, Tabriz University of Medical Sciences
Full name of responsible person
Dr Rasoolazeen
Street address
Research Department, Central Building , Golgasht , Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Alehe Seyyedrasooly
Position
Ms , Faculty member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Shariati South Street , Tabriz, Iran
City
Tabriz
Postal code
5138947-977
Phone
+98 41 1479 6770
Fax
+98 41 1479 6969
Email
seyyedrasooly@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahnaz Jabraeili
Position
Ms, Faculty member
Other areas of specialty/work
Street address
School of Nursing and Midwifery , Shariati South Street , Tabriz , Iran
City
Tabriz
Postal code
5138947-977
Phone
+98 41 1479 6770
Fax
+98 41 1479 6969
Email
jabraeilim@tbzmed.ac.irjebreilim@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahnaz Jabraeili
Position
Ms, Faculty member
Other areas of specialty/work
Street address
School of Nursing and Midwifery , Shariati South Street, Tabriz , Iran
City
Tabriz
Postal code
5138947-977
Phone
+98 411476770
Fax
+98 41 1479 6969
Email
jebreilim@yahoo.comjabraeilim@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)