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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
Scientific title
Effectiveness of human milk in pain relief during eye exam for retinopathy of prematurity in premature newborn
Secondary ID [1] 259654 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pain relief in pre-term newborn during eye exam for diagnosis of ROP 261214 0
Condition category
Condition code
Anaesthesiology 259365 259365 0 0
Pain management
Reproductive Health and Childbirth 265720 265720 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 258081 0
Treatment: Other
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
Control group
Active

Outcomes
Primary outcome [1] 262180 0
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.
Timepoint [1] 262180 0
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
Primary outcome [2] 262310 0
Salivary cortisol;
Timepoint [2] 262310 0
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;
Primary outcome [3] 266461 0
NFCS - Neonatal Face Coding Systems
Timepoint [3] 266461 0
NFCS-20s baseline (before the eye exam), 20s final of the eye exam and 20s final recovery (after the eye exam);
Secondary outcome [1] 273275 0
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.
Timepoint [1] 273275 0
State of sleep and wakefulness- Baseline (5 min before the eye exam)during the eye exam , and recovery (5 min after the eye exam)
Secondary outcome [2] 273782 0
Crying time
Timepoint [2] 273782 0
Crying time- Baseline (5 min before the eye exam), during the eye exam and recovery (5 min after the eye exam)

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.
Minimum age
28 Weeks
Maximum age
32 Weeks
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Ventilator support
Analgesic Therapy
kidney disease
intra-ventricular hemorrage grade III or IV

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
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
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
premature newborn receive different interventions during the same time span of the study.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3217 0
Brazil
State/province [1] 3217 0
Sao Paulo
Country [2] 3218 0
Brazil
State/province [2] 3218 0
Ribeirao preto

Funding & Sponsors
Funding source category [1] 258541 0
Charities/Societies/Foundations
Name [1] 258541 0
National Council for Scientific and Technological Development (CNPq)
Address [1] 258541 0
SHIS block 01 Conjunt B -
Dumont building
Lago Sul, Brasilia - DF
post code: 71605001.
Country [1] 258541 0
Brazil
Primary sponsor type
Individual
Name
Laiane Medeiros Ribeiro
Address
Capitao Pereira Lago street
number 1525 apartment 09
Monte Alegre, Ribeirao Preto, Sao Paulo
postcode: 14.051130
Country
Brazil
Secondary sponsor category [1] 257677 0
Individual
Name [1] 257677 0
Carmen Gracinda Silvan Schochi
Address [1] 257677 0
Bandeirantes Avenue number 3900
Monte Alegre
Ribeirao Preto- Sao Paulo
postcode:14.040-902
Country [1] 257677 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260512 0
Ethics in Research of Hospital and Medical School of Ribeirao Preto
Ethics committee address [1] 260512 0
Cuiaba street number 601
postcode:14055-370
Ribeirao Preto-Sao Paulo
Ethics committee country [1] 260512 0
Brazil
Date submitted for ethics approval [1] 260512 0
Approval date [1] 260512 0
Ethics approval number [1] 260512 0
11027/2010

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?
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32250 0
Address 32250 0
Country 32250 0
Phone 32250 0
Fax 32250 0
Email 32250 0
Contact person for public queries
Name 15497 0
Laiane Medeiros Ribeiro
Address 15497 0
Capitao Pereira Lago street, number 1525, apartment 09
Monte Alegre
Ribeirao Preto-SP
postocode:14-051-130
Country 15497 0
Brazil
Phone 15497 0
+ 55 (016) 3602-3411
Fax 15497 0
Email 15497 0
laiane@usp.br
Contact person for scientific queries
Name 6425 0
Carmen Gracinda Silvan Scochi
Address 6425 0
Bandeirantes avenue 3900
Monte Alegre
Ribeirao Preto,Sao Paulo
postocode:14.040-902
Country 6425 0
Brazil
Phone 6425 0
+ 55 (016)3602-3411
Fax 6425 0
Email 6425 0
cscochi@eerp.usp.br

No information has been provided regarding IPD availability
Summary results
No Results