NCT03302000

Visual Stimulation of Preterm Infants

Early Visual Stimulation in Preterm Infants at Home From 0 to 3 Months

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Universidade Federal de Santa Catarina · Academic / Other
• Sex: All
• Age: 1 Month – 2 Months
• Healthy volunteers: Accepted

Summary

Introduction: Prematurity rate has increased and is a risk factor for developmental delay. Preterm infants with low visual tracking might present deficits in cognition, language, and fine motor function in future ages. Few studies applied home stimulation of the visual system for preterm infant (PT) at an early age. Objective: To compare the effects of early visual stimulation to a standard care group in visual function, motor and sensory development. Methods: Randomized controlled trial. At home setting. Thirty healthy preterm infants, gestational age from 28 to 37 weeks, aged from one to two months of corrected age at the entrance of the study, with low visual function, will be evaluated. Participants will be randomly allocated to: (1) a standard care group, receiving orientation about general sensory and motor development, (2) an early visual stimulation group receiving a 4-week home based protocol applied by caregivers additional to standard care. Outcomes will be measured at before the beginning of stimulation, at the end of stimulation and at 6 months of corrected age. Primary outcome is visual function evaluated by ML Leonhardt Battery of Optotypes. Secondary outcomes include motor and sensory development evaluated by scales.

Conditions

• Preterm Infant

Interventions

Type	Name	Description
OTHER	Early Visual Stimulation	Early visual stimulation
OTHER	standard care	standard care

Timeline

• Start date: 2018-09-01
• Primary completion: 2019-12-30
• Completion: 2019-12-31
• First posted: 2017-10-04
• Last updated: 2020-06-23

Locations

1 site across 1 country: Brazil