Visual Stimulation of Preterm Infants

NCT03302000 | Completed

• 1 other identifier: UFSC-SIGPEX / 201610782
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Infant

Keywords

prematurity; sensory stimulation; rehabilitation; infant

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (3)

• Sensory profile

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

• Motor Development

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

• Motor Development

  change measure: at 6 months of corrected age

Study Arms (2)

Visual stimulation

EXPERIMENTAL

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

standard care

OTHER

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

Interventions

Early Visual Stimulation OTHER

Early visual stimulation

Visual stimulation

standard care OTHER

standard care

Visual stimulation; standard care

Eligibility Criteria

• Age: 1 Month - 2 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Santa Catarina: lead

Study Sites (1)

Universidade Federal de Santa Catarina

Araranguá, Santa Catarina, 88.906-072, Brazil

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Two kind of researchers will be part of the study: a) assessors, which are the researchers that will perform assessments and apply stimulation with the caregivers; b) ratters, which are the researchers that will rate the scales from videos. Assessors will not be blind to group allocation. Ratters will be masked to group allocation, since videos analyses will be performed using coded study allocation. The statistician will also be blind to group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Reseacher

Model Details: 2-arm, parallel-groups, pragmatic superiority randomised controlled trial. Allocation ratio will be 1:1

Study Record Dates

• First Submitted: September 30, 2017
• First Posted: October 4, 2017
• Study Start: September 1, 2018
• Primary Completion: December 30, 2019
• Study Completion: December 31, 2019
• Last Updated: June 23, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within one year of study completion

Locations

BR (1)