An interventional study of Early Visual Stimulation and standard care in Preterm Infant, sponsored by Universidade Federal de Santa Catarina. Completed at 1 site in Brazil. Open to participants aged 1 Month to 2 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-23.
Sponsored by Universidade Federal de Santa Catarina · Not applicable, Interventional, and Prevention
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.
Exclusion Criteria:
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.
Other: Early Visual Stimulation · Other: standard care
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.
Other: standard care
Early visual stimulation
standard care
Visual function - alertness, fixation, attention, tracking
Visual acuity will be assessed with ML Leonhardt Battery of Optotypes (MLLBOS) scale. MLLBOS consists of 8 visual carts, with high-contrast visual images of 12X12cm. The scale evaluates alertness, attention, fixation and visual tracking. The evaluation will be recorded by a digital video camera. The camera will be positioned fixed to the infant's face.
Time frame: change measure: first day - before intervention; after intervention at home (28 days)
Sensory profile
Infant Sensory Profile Scale (SPS) is a 125 item, norm-referenced, parent-report questionnaire. Sensory processing is divided in six items: general processing, auditory processing, visual processing, tactile processing, vestibular processing and oral sensory processing.
Time frame: change measure: first day - before intervention; after intervention at home (28 days); at 6 months of corrected age
Motor Development
Motor development will be assessed with Test of Infant Motor Performance (TIMP). It is a functional motor scale for newborn infants and infants under 4 months of age. Twenty-eight Observed Items examine spontaneously emitted movements, such individual finger, ankle and wrist movements. Thirty-one Elicited Items, scored on 5-, 6-, or 7-point ordinal scales, test infant's movement responses to placement in various spatial orientations and to interesting sights and sounds.
Time frame: change measure: first day - before intervention; after intervention at home (28 days)
Motor Development
Motor development will be assessed with Alberta Infant Motor Scale (AIMS). The AIMS is a validated and reliable measure of infant's development. The assessors observe the spontaneous repertoire of infant's skills detected through 58 items grouped under four postures: prone (21 items), supine (9 items), sitting (12 items), and standing (16 items)
Time frame: change measure: at 6 months of corrected age
Plan to share: Yes — De-identified individual participant data for all primary and secondary outcome measures will be available
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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Universidade Federal de Santa Catarina