Comparing the Effects of the Breast milk and Sucrose on Pain and Coping with Stress during Retinopathy Examination of Premature Infants
Design
This study will conductewith 63 preterm infants (breast milk group=21, sucrose group=21, and control/distilled water group=21).
Convenience sampling and random assignment are sealed envelope.
A clinical trial with a community-based and pragmatic control group, with parallel, double blinded, and randomized groups.
Settings and conduct
Sampling place is in Farabi Hospital.
Two minutes before the examination, 0.5 mililiter per kilogram of sucrose solution or breast milk or distilled water is fed to the infant by syringe.
starting five minutes before the examination, up to fifteen minutes later, a video recording will be made. The infants' Vital signs will be recorded in five steps (5 minutes before the examination, just starting and in minutes 5, 10 and 15 after examination).
Pain and stress assessment is also done by video observation using ALPS-Neo pain and stress scale.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Preterm infants born at or below 32 weeks of gestational age and birth weight at or below 2000 grams.
Non-entry criteria: infants diagnosed with a congenital anomaly.
Intervention groups
In breast milk group, two minutes before the examination, 0.5 mililiter per kilogram of breast milk is fed to the infant by syringe.
In sucrose group, two minutes before the examination, 0.5 mililiter per kilogram of sucrose 24% is fed to the infant by syringe.
In distilled water group, two minutes before the examination, 0.5 mililiter per kilogram of distilled water is fed to the infant by syringe.
Main outcome variables
Pain and coping with stress score during retinopathy examinations in preterm infants.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180718040523N1
Registration date:2018-08-04, 1397/05/13
Registration timing:prospective
Last update:2018-08-04, 1397/05/13
Update count:1
Registration date
2018-08-04, 1397/05/13
Registrant information
Name
Aida Safaiee Fakhr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3377 9923
Email address
a-safaieef@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-05, 1397/05/14
Expected recruitment end date
2018-10-06, 1397/07/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effects of the Breast milk and Sucrose on Pain and Coping with Stress during Retinopathy Examination of Premature Infants
Public title
Effect of Breast milk and Sucrose on Pain and Coping with Stress
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Premature infants born at or below 32 weeks of gestational age
Preterm infants that born with a birth weight at or below 2000 gram.
Exclusion criteria:
Preterm infants diagnosed with a congenital anomaly, hydrocephalus, necrotizan enterocolitis, indirect hyperbilirubinemia.
Age
To 60 days old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
63
Randomization (investigator's opinion)
Randomized
Randomization description
Convenience sampling (Anyone who had the inclusion criteria entered the study).
and random assignment are sealed envelope (Samples of sucrose, breast milk and distilled water are placed inside the envelopes, and before sampling, one of the envelopes is selected by the secretary and the intervention is done).
Blinding (investigator's opinion)
Double blinded
Blinding description
An eye examiner will be unaware of the type of intervention.
The parents and, subsequently, the infant will be unaware of the type of substance received.
Evaluators the film will be unaware of the intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Joint Organizational Ethics Committee of Faculty of Nursing and Midwifery and Rehabilitation, Tehran
Street address
Nosrat street.,Tohid square437
City
Tehran
Province
Tehran
Postal code
3471874439
Approval date
2018-03-13, 1396/12/22
Ethics committee reference number
IR.TUMS.FNM.REC.1397.052
Health conditions studied
1
Description of health condition studied
Retinopathy of Prematurity
ICD-10 code
H35.1
ICD-10 code description
Retinopathy of prematurity
Primary outcomes
1
Description
pain
Timepoint
5 minutes before examination- the moment of starting examination, minutes 5, 10, 15
Method of measurement
ALPS-Neo Pain and Stress assessment Scale
Secondary outcomes
1
Description
Coping with stress
Timepoint
5 minutes before examination, the moment of the examination, minutes 5, 10, 15
Method of measurement
with ALPS-Neo pain and stress assessment scale
Intervention groups
1
Description
Intervention group: In this group infants 0.5 mililiter per kilogram from their mother milk recive orally 2 minutes before examination
Category
Treatment - Other
2
Description
Intervention group: In this group infants 0.5 mililiter per kilogram from sucrose 24% sulotion recive orally 2 minutes before examination
Category
Treatment - Other
3
Description
Control group: In this group infants 0.5 mililiter per kilogram from distilled water recive orally 2 minutes before examination
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi hospital
Full name of responsible person
Aida Safaiee Fakhr
Street address
Qazvin Square, karegar street
City
Tehran
Province
Tehran
Postal code
3471874439
Phone
+98 28 3377 9923
Email
safaieea@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vida kardan
Street address
Nosrat Street, Tohid Square
City
Tehran
Province
Tehran
Postal code
3471874439
Phone
+98 28 3377 9923
Email
safaieea@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Aida Safaiee Fakhr
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nosrat Street,Tohid Square
City
Tehran
Province
Tehran
Postal code
3471874439
Phone
+98 28 3377 9923
Email
Safaieea@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Jila Mirlashari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nosrat Street, Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4426
Email
jmirlashari@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Aida Safaiee Fakhr
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nosrat Street, Tohid Square
City
Tehran
Province
Tehran
Postal code
3471874439
Phone
+98 28 3377 9923
Email
safaieea@yahoo.com
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