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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000375954
Enrollment
96
Registered
2011-04-12
Start date
2011-04-29
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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?

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 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 exam

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

Sponsors

Laiane Medeiros Ribeiro
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
28 Weeks to 32 Weeks
Healthy volunteers
No

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.

Exclusion criteria

Ventilator support Analgesic Therapy kidney disease intra-ventricular hemorrage grade III or IV

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026