Clinical trial NCT03302000: Visual Stimulation of Preterm Infants
Official title: Early Visual Stimulation in Preterm Infants at Home From 0 to 3 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Infant
Keywords: prematurity
sensory stimulation
rehabilitation
infant
Lead sponsor: Universidade Federal de Santa Catarina
Sponsor class: OTHER
First posted: 2017-10-04
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2-arm, parallel-groups, pragmatic superiority randomised controlled trial. Allocation ratio will be 1:1
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Visual function - alertness, fixation, attention, tracking
timeFrame: change measure: first day - before intervention; after intervention at home (28 days)
Secondary outcomes:
measure: Sensory profile
timeFrame: change measure: first day - before intervention; after intervention at home (28 days); at 6 months of corrected age
measure: Motor Development
timeFrame: change measure: first day - before intervention; after intervention at home (28 days)
measure: Motor Development
timeFrame: change measure: at 6 months of corrected age
Other outcomes:
Locations:
city: Araranguá
country: Brazil
facility: Universidade Federal de Santa Catarina
state: Santa Catarina
Study officials:
References: