Visual Stimulation of Preterm Infants

Universidade Federal de Santa Catarina

Status: Completed

Conditions: Preterm Infant

Treatments: Other: standard care; Other: Early Visual Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03302000

UFSC-SIGPEX / 201610782

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 1 to 2 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• gestational age between 28 and 37 weeks
• age at enrolment between one to two months of corrected age t
• absence of visual impairments evaluated with Red Reflex Examination and complete ophthalmology exam, which will be performed by a doctor at the hospital or the basic health units where the infants will be recruited
• infants at home
• presence of low acuity assessed by the ML-Leonhardt Optotypes Battery (absence of alertness, fixation and attention in at least three cards, or visual tracking classified as absent or brief for more than three cards)

Exclusion criteria

• presence of any diagnosed neurological diseases
• presence of diagnosed respiratory diseases
• hypoxemia, hyperventilation or hypo-ventilation during assessments
• presence of congenital diseases
• presence of diagnosed visual impairments, such as blindness or low vision
• extreme premature, ie, with gestation age bellow 28 weeks due to higher risk of retinopathy of prematurity
• birth weight less than 1,000 grams due to higher risk of retinopathy of prematurity
• absence of alertness according with Precthl and Beintema
• preterm infant with unstable physiological conditions
• preterm infant receiving any kind of intervention such as physical therapy, occupational therapy, early intervention, aquatic stimulation, at the same time that our stimulation protocol is being applied since they can be confounders
• infants with medical fragility that prevent them to participate.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Visual stimulation

Experimental group

Description:

Early visual stimulation (EVS) will be implemented by caregivers. Three phases: 1. the caregiver will establish eye-to-eye contact with the infant. The caregiver will communicate with the infant talking, singing, changing facial expressions, touching his/her face. Total duration of this part of stimulation is between 2 and 3 minutes 2. the caregivers will present visual contrast cards at a distance of 15-20 centimetres 3. the caregiver will present two toys to the infant Stimulation will last for 28 days (4 weeks) in total, one time a day for 10-15 minutes, all days week.

Treatment:

Other: Early Visual Stimulation

Other: standard care

standard care

Other group

Description:

Caregivers will receive an Illustrated Handbook, according to the age range of birth to three months. Assessors will explain all information contained in the handbook after the first assessment and randomisation.

Treatment:

Other: standard care