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Trial registered on ANZCTR
Registration number
ACTRN12611000375954
Ethics application status
Approved
Date submitted
21/02/2011
Date registered
12/04/2011
Date last updated
6/09/2011
Type of registration
Prospectively registered
Titles & IDs
Public title
Effectiveness of human milk in pain relief during eye exam for retinopathy of prematurity in premature newborn
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Scientific title
Effectiveness of human milk in pain relief during eye exam for retinopathy of prematurity in premature newborn
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Secondary ID [1]
259654
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
pain relief in pre-term newborn during eye exam for diagnosis of ROP
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Condition category
Condition code
Anaesthesiology
259365
259365
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0
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Pain management
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Reproductive Health and Childbirth
265720
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0
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Complications of newborn
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The researcher or research assistent will administer one drop in each eye of tropicamide and phenylephrine in both eyes 60-90 min before the examination.
the ophthalmologist views the retina with the indirect ophthalmoscope, directing its light and optical paths through a hand-held condensing lens. The infant’s eyes, with pupils pharmacologically dilated, are held open by an eyelid speculum. A scleral depressor is used to indent the wall of the eye to visualize the retinal periphery. The examination takes about 5 minutes.
We will install the electrodes in the heart of newborn premature chest to measure heart rate to measure heart rate. With the infant in the incubator, face images will be recorded with a sony camera for further analysis facial during 5 minutes (baseline phase). Heart Rate will aso be monitored second-by-second by Biopac.Two patches / electrodes placed on the chest of the newborn baby while the baby is lying in the crib or incubator. After the instillation of 2 drops of citric acid into infant’s mouth, neonatal saliva sample will be collected 5-10 min before the start of eye examination. The infant will be transferred to a basinet and swaddle with a blanket. 2min before the eye exam 2ml of human milk will be administered by research assistent via oral using a syringe.The eye examination is performed by an ophthalmologist
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Intervention code [1]
258081
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Treatment: Other
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Comparator / control treatment
We wil compare with 0.5/kg sucrose 24% (control group) and 2ml of human milk (Intervention group).
For administration of sucrose or human milk will be used a syringe 3ml without needle, orally administered 2 minutes before the procedure. Sucrose is a lower dosage, it is hospital protocol dosage of 0.5/kg
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Control group
Active
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Outcomes
Primary outcome [1]
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Heart Rate.
The heart rate will be measured through a device that measures heart rate second per second called Biopac. For that electrodes will be installed to monitor the brand Red Dot 2258-3 chest of the newborn.
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Assessment method [1]
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Timepoint [1]
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Baseline ( before the procedure)-5 min before the eye exam
During the time of eye exam to diagnosis for retinopathy of prematurity.
Recovery ( after the procedure) -5 min after the eye exam
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Primary outcome [2]
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Salivary cortisol;
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Assessment method [2]
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Timepoint [2]
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salivary cortisol will be three measures-Baseline (5 min before the eye exam), 30 min after exam (peak cortisol) and 60 min after the start of the eye exam;
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Primary outcome [3]
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NFCS - Neonatal Face Coding Systems
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Assessment method [3]
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Timepoint [3]
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NFCS-20s baseline (before the eye exam), 20s final of the eye exam and 20s final recovery (after the eye exam);
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Secondary outcome [1]
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State of sleep and wakefulness
To assess the state of sleep and wakefulness follow states of deep sleep to crying, as follows: 1 = deep sleep, active sleep = 2, 3 = drowsy, quiet alert = 4, 5 = active alert, crying = 6. Such states were described by Prechtl (1974) in article The Behavioural States of the Newborn Infant ( A Review).
for baseline and recovery phases, will be coded 5 minutes early. if the phase of the procedure, will be coded continuously since the beginning of the instillation of topical anesthetic until the end of the exam.
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Assessment method [1]
273275
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Timepoint [1]
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State of sleep and wakefulness- Baseline (5 min before the eye exam)during the eye exam , and recovery (5 min after the eye exam)
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Secondary outcome [2]
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Crying time
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Assessment method [2]
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Timepoint [2]
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Crying time- Baseline (5 min before the eye exam), during the eye exam and recovery (5 min after the eye exam)
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Eligibility
Key inclusion criteria
Birth weight less than or equal tto 1,500g or GA less than or equal to 32 wk; clinically stable and minimum time of 1 hour of the last feeding.
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Minimum age
28
Weeks
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Maximum age
32
Weeks
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Ventilator support
Analgesic Therapy
kidney disease
intra-ventricular hemorrage grade III or IV
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Only one research assistant will have information about the allocation of groups together with the statistics. The researcher will not know which infants receive human milk or sucrose.
Simple randomisation by using a randomization table created by a computer software.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation of premature infants in each group (sucrose-control group or human milk-intervention group ) will be random, using for such a computer program. The study will be blinded, as the principal investigator and others involved with management of research data will not be aware of the group in which each early fall. To this end, a third person will administer sucrose or human milk, using a syringe with 3ml wrapped matte paper.Simple randomisation by using a randomization table created by a computer software
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
premature newborn receive different interventions during the same time span of the study.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
29/04/2011
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
96
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
3217
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Brazil
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State/province [1]
3217
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Sao Paulo
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Country [2]
3218
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Brazil
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State/province [2]
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Ribeirao preto
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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National Council for Scientific and Technological Development (CNPq)
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Address [1]
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SHIS block 01 Conjunt B -
Dumont building
Lago Sul, Brasilia - DF
post code: 71605001.
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Country [1]
258541
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Brazil
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Primary sponsor type
Individual
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Name
Laiane Medeiros Ribeiro
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Address
Capitao Pereira Lago street
number 1525 apartment 09
Monte Alegre, Ribeirao Preto, Sao Paulo
postcode: 14.051130
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Country
Brazil
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Secondary sponsor category [1]
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Individual
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Name [1]
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Carmen Gracinda Silvan Schochi
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Address [1]
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Bandeirantes Avenue number 3900
Monte Alegre
Ribeirao Preto- Sao Paulo
postcode:14.040-902
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Country [1]
257677
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Brazil
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
260512
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Ethics in Research of Hospital and Medical School of Ribeirao Preto
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Ethics committee address [1]
260512
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Cuiaba street number 601
postcode:14055-370
Ribeirao Preto-Sao Paulo
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Ethics committee country [1]
260512
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Brazil
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Date submitted for ethics approval [1]
260512
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Approval date [1]
260512
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Ethics approval number [1]
260512
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11027/2010
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Summary
Brief summary
Investigate the effectiveness of 2ml of human milk compared with 0.5 per kg of sucrose 24% on pain relief in pre-term newborn during eye exam for diagnosis of ROP.
Hypothesis: the human milk is as effective in relieving acute pain in newborn preterm as sucrose?
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
32250
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Address
32250
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Laiane Medeiros Ribeiro
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Address
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Capitao Pereira Lago street, number 1525, apartment 09
Monte Alegre
Ribeirao Preto-SP
postocode:14-051-130
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Country
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Brazil
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Phone
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+ 55 (016) 3602-3411
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Carmen Gracinda Silvan Scochi
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Address
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Bandeirantes avenue 3900
Monte Alegre
Ribeirao Preto,Sao Paulo
postocode:14.040-902
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Country
6425
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Brazil
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Phone
6425
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+ 55 (016)3602-3411
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Fax
6425
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Email
6425
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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