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Completed

NCT Number: NCT03302000

Visual Stimulation of Preterm Infants

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.

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Key information

Conditions

Preterm Infant Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

1 month–2 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal de Santa Catarina

Araranguá, Santa Catarina, 88.906-072, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Early Visual Stimulation

Other

Early visual stimulation

Standard care

Other

standard care

Primary outcomes

  1. Visual function - alertness, fixation, attention, tracking

    Time frame: change measure: first day - before intervention; after intervention at home (28 days)

    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.

Secondary outcomes

  1. Sensory profile

    Time frame: change measure: first day - before intervention; after intervention at home (28 days); at 6 months of corrected age

    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.

  2. Motor Development

    Time frame: change measure: first day - before intervention; after intervention at home (28 days)

    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.

  3. Motor Development

    Time frame: change measure: at 6 months of corrected age

    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)

Sponsors and collaborators

Lead sponsor

Universidade Federal de Santa Catarina

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 4, 2017
Registry last updated
Jun 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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