Protocol summary

Study aim
The main objective: Evaluation the effect of prone and right lateral positions on gastric residual volume in preterm infants
Design
This study was a cross-sectional clinical trial. 52 infants with inclusion criteria were selected by objective method and entered the study. Then in the form of random block assignment (quadruple block), they will fall into two groups A and B. Babies of group A are placed in position on the abdomen and group B in the position on the right side (the babies will be placed in the position during placement or the same nest).
Settings and conduct
This study will be carried out in NICU and neonates in Amirkabir Hospital in Arak, and the 17th Shahrivar Hospital in Saveh. The study was done so that premature infants according to entry criteria enter the study, then before and after feeding through gavage at minutes 30, 60, 90, and 120, the gastric residual volume in both prone and right lateral positions will be measured by gavage syringe which will also be in milliliters, and will be written in the checklist for each baby (the infant will stay for 120 minutes in each position). Blinding is not done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The consent of the infant's parents to intervene Breast feeding by gavage The infants from 28 to 36 weeks The weight between 800 and 2500 grams The hospitalization for at least 2 days The lack of connection to the ventilator Exclusion criteria: Resumption of oral nutrition Parents' unwillingness to continue the study The presence of digestive problems Intravntricular hemorrhage Necrotizing enterocolitis Apnea Seizure Infant death
Intervention groups
In this study, premature infants that have been born between the 28 and 36 weeks uterine age will be interfered. infants who come to the study according to the criteria of entry, according to the codes obtained by statistical analysis of the blocking, receive the first feeding in one position and the next time in the other position, and the gastric residual volume will be measured before the gavage and It will also be measured in both minutes at 30, 60, 90 and 120 after the gavage. This study is due to the fact that it is cross-linked, and each group is also a control group.
Main outcome variables
Improve the infant's development, reducing the complications associated with premature infants

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171203037733N1
Registration date: 2017-12-19, 1396/09/28
Registration timing: prospective

Last update: 2017-12-19, 1396/09/28
Update count: 0
Registration date
2017-12-19, 1396/09/28
Registrant information
Name
Mehran Akbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
m.akbari@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of prone and right lateral positions on gastric residual volume in preterm infants
Public title
The effect of two positions on the gastric residual volume of premature infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The consent of the infant's parents to intervene Breast feeding by gavage The infants with uterine age from 28 to 36 weeks The weight between 800 and 2500 grams The hospitalization for at least 2 days The lack of connection to the ventilator
Exclusion criteria:
Resumption of oral nutrition Parents' unwillingness to continue the study The presence of digestive problems Intravntricular hemorrhage Necrotizing enterocolitis Apnea Seizure Infant death
Age
From 7 months old to 9 months old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 52
Randomization (investigator's opinion)
Randomized
Randomization description
Infants eligible for inclusion are selected in a goal-based manner and are enrolled in the study. Then in the form of a randomized block assignment (quadruple block), which will be provided by the relevant software and by the statistics expert, they will fall into two groups A and B. Babies of group A are placed in position on the abdomen and group B in the position on the right side (the newborns will be placed inside the nest during placement). after a certain amount of gastric residual volume measurement, the position of both groups will be change.
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
Ethics committee of Arak University of Medical Sciences
Street address
Third Floor, blue Wing, Payambar aazam (SAW) University Complex, Basij SQ, Sardasht region
City
Arak
Province
Markazi
Postal code
6941-7-38481
Approval date
1994-04-03, 1373/01/14
Ethics committee reference number
IR.ARAKMU.REC.1396.192

Health conditions studied

1

Description of health condition studied
Prematurity
ICD-10 code
Z76.2
ICD-10 code description
Encounter for health supervision and care of other healthy infant and child

Primary outcomes

1

Description
Gastric Residual Volume
Timepoint
Before the gavage, as well as at 30, 60, 90 and 120 minutes after gavage
Method of measurement
Gavage syringe

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Infants that in the group (A), will be placed in the prone position and the gastric residual volume will be measured before the gavage, and at 90, 60, 30 and 120 minutes after the gavage, and after 3 hours from the start of the gavage, this group (A) of infants will be placed in the right lateral position position and gastric residual volume will be measured before the gavage, and also at 90, 60, 30 and 120 minutes after the gavage.
Category
N/A

2

Description
Intervention group: Infants that in the group (B), will be placed in the right lateral position and the gastric residual volume will be measured before the gavage, and at 90, 60, 30 and 120 minutes after the gavage, and after 3 hours from the start of the gavage, this group (B) of infants will be placed in the prone position position and gastric residual volume will be measured before the gavage, and also at 90, 60, 30 and 120 minutes after the gavage.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Neonatal Intensive Care Unit and Neonatal waed in Amirkabir hospital
Full name of responsible person
Mehran Akbari
Street address
Nursing Square, Alam al-Hoda Street, Shahid Shiroudi Street
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 86 3313 4717
Email
m.akbari@arakmu.ac.ir

2

Recruitment center
Name of recruitment center
Neonatal Intensive Care Unit in17 Shahrivar hospital
Full name of responsible person
Mehran Akbari
Street address
Shahrivar Hospital, Motahari St., Modarres Blvd, Saveh town
City
Saveh
Province
Markazi
Postal code
۴۴۱۴۶ -۳۹۱۵۶
Phone
+98 86 4222 3026
Email
m.akbari@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Arjmandzadegan
Street address
Deputy of research and technology, Payambar aazam (SAW) University Complex, Basij SQ, Sardasht region
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3645
Email
arjomandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Mehran Akbari
Position
MSc Student in pediatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Third Floor, blue Wing, Payambar aazam (SAW) University Complex, Basij SQ, Sardasht region
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 86341735057
Email
m.akbari@arakmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehran akbari
Position
MSc student in pediatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Third Floor, blue Wing, Payambar aazam (SAW) University Complex, Basij SQ, Sardasht region
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
0089 86 34173505-7
Email
m.akbari@arakmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehran Akbari
Position
MSc student in pediatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Third Floor, blue Wing, Payambar aazam (SAW) University Complex, Basij SQ, Sardasht region
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 86341735057
Email
m.akbari@arakmu.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
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