Effect of nest position versus supine position on gastric residual volume after gavage in premature neonates: a single-blind crossover randomized clinical trial
To assess the effect of nest position versus supine position on gastric residual volume after gavage in premature neonates
Design
This a single-blind crossover randomized clinical trial, phase II, in which 70 eligible premature neonates will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible premature neonates who will refer to Amiralmomenin Hospital during the study period will be enrolled in the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 32 to 37 weeks
Birth weight less than 3000 g
Prematurity
Exclusion criteria:
Gastrointestinal abnormalities
Need to incubator
Genetic disease
Intervention groups
Intervention group: Putting neonate in the nest position during gavage two times with 2 hours interval
Control group: Putting neonate in the supine position during gavage two times with 2 hours interval
Main outcome variables
Primary outcome: Measuring the gastric residual volume after gavage immediately after intervention through physical examination
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N206
Registration date:2018-02-15, 1396/11/26
Registration timing:registered_while_recruiting
Last update:2018-02-15, 1396/11/26
Update count:0
Registration date
2018-02-15, 1396/11/26
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of nest position versus supine position on gastric residual volume after gavage in premature neonates: a single-blind crossover randomized clinical trial
Public title
Effect of nest position versus supine position on gastric residual volume after gavage in premature neonates
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 32 to 37 weeks
Birth weight less than 3000 g
Prematurity
Exclusion criteria:
Gastrointestinal abnormalities
Need to incubator
Genetic disease
Age
From 1 day old to 1 day old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through drawing of lots. For this purpose, we write intervention and control on two paper sheets. Then every neonate will be assigned either to intervention or to control group one basis of drawing lots.
Blinding (investigator's opinion)
Single blinded
Blinding description
Neonates will be unaware of the type of intervention. Therefore, the trial will be run as single-blind
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2017-11-13, 1396/08/22
Ethics committee reference number
IR.UMSHA.REC.1396.545
Health conditions studied
1
Description of health condition studied
Premature neonates
ICD-10 code
P07.3
ICD-10 code description
Preterm [premature] newborn [other]
Primary outcomes
1
Description
Measuring the gastric residual volume after gavage
Timepoint
Immediately after intervention
Method of measurement
Through physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Putting neonate in the nest position during gavage two times with 2 hours interval
Category
Other
2
Description
Control group: Putting neonate in the supine position during gavage two times with 2 hours interval
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Fatemeh Sargolzaei
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
fa.sargolzaei@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Fatemeh Sargolzaei
Position
MSc in Nursery
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
fa.sargolzaei@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Fatemeh Cheraghi
Position
PhD in Pediatric Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
F_cheraghi@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be 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