RecruitingACTRN12611000375954

Effectiveness of human milk in pain relief during eye exam for retinopathy of prematurity in premature newborn


Sponsor

Laiane Medeiros Ribeiro

Enrollment

96 participants

Start Date

Apr 29, 2011

Study Type

Interventional

Conditions

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?


Eligibility

Sex: Both males and femalesMin Age: 28 WeekssMax Age: 32 Weekss

Plain Language Summary

Simplified for easier understanding

This study is comparing whether human breast milk is as effective as a sweet sucrose (sugar) solution at reducing pain in premature babies during an eye examination. Premature babies sometimes need an eye check to look for a condition called retinopathy of prematurity (ROP), which can affect vision. The exam can be uncomfortable. Sugar solution is currently used to reduce pain, and this study will see if human breast milk works just as well. You may be eligible if: - Your baby was born weighing 1,500 grams or less, OR was born at 32 weeks of pregnancy or earlier - Your baby is clinically stable - At least 1 hour has passed since your baby's last feed You may NOT be eligible if: - Your baby is on a ventilator - Your baby is receiving pain medications - Your baby has kidney disease - Your baby has had a severe brain bleed (grade III or IV intraventricular hemorrhage) Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 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


Locations(2)

Sao Paulo, Brazil

Ribeirao preto, Brazil

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ACTRN12611000375954