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Visual Stimulation of Preterm Infants

NCT03302000 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-06-23

No results posted yet for this study

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

OTHER

Early Visual Stimulation

Early visual stimulation

OTHER

standard care

standard care

Sponsors & Collaborators

  • Universidade Federal de Santa Catarina

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
2 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2019-12-30
Completion
2019-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03302000 on ClinicalTrials.gov