Protocol summary
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Study aim
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Comparing the Effects of the Breast milk and Sucrose on Pain and Coping with Stress during Retinopathy Examination of Premature Infants
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Pain and coping with stress score during retinopathy examinations in preterm infants.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180718040523N1
Registration date:
2018-08-04, 1397/05/13
Registration timing:
prospective
Last update:
2018-08-27, 1397/06/05
Update count:
1
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Registration date
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2018-08-04, 1397/05/13
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-08-05, 1397/05/14
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Expected recruitment end date
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2018-10-06, 1397/07/14
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparing the Effects of the Breast milk and Sucrose on Pain and Coping with Stress during Retinopathy Examination of Premature Infants
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Public title
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Effect of Breast milk and Sucrose on Pain and Coping with Stress
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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.
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Age
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From 28 days old to 60 days old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
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Sample size
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Target sample size:
63
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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).
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-03-13, 1396/12/22
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Ethics committee reference number
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IR.TUMS.FNM.REC.1397.052
Health conditions studied
1
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Description of health condition studied
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Retinopathy of Prematurity
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ICD-10 code
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H35.1
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ICD-10 code description
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Retinopathy of prematurity
Primary outcomes
1
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Description
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pain
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Timepoint
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5 minutes before examination- the moment of starting examination, minutes 5, 10, 15
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Method of measurement
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ALPS-Neo Pain and Stress assessment Scale
Secondary outcomes
1
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Description
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Coping with stress
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Timepoint
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5 minutes before examination, the moment of the examination, minutes 5, 10, 15
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Method of measurement
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with ALPS-Neo pain and stress assessment scale
Intervention groups
1
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Description
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Intervention group: In this group infants 0.5 mililiter per kilogram from their mother milk recive orally 2 minutes before examination
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Category
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Treatment - Other
2
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Description
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Intervention group: In this group infants 0.5 mililiter per kilogram from sucrose 24% sulotion recive orally 2 minutes before examination
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Category
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Treatment - Other
3
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Description
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Control group: In this group infants 0.5 mililiter per kilogram from distilled water recive orally 2 minutes before examination
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available