Visual Stimulation of Preterm Infants

• ClinicalTrials.gov Identifier: NCT03302000
• Recruitment Status: Completed
• First Posted: October 4, 2017
• Last Update Posted: June 23, 2020
• Sponsor: Universidade Federal de Santa Catarina
• Information provided by (Responsible Party): Adriana Neves Dos Santos, Universidade Federal de Santa Catarina

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Preterm Infant	Other: Early Visual Stimulation; Other: standard care	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 2-arm, parallel-groups, pragmatic superiority randomised controlled trial. Allocation ratio will be 1:1
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: 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.
• Primary Purpose: Prevention
• Official Title: Early Visual Stimulation in Preterm Infants at Home From 0 to 3 Months
• Actual Study Start Date: September 1, 2018
• Actual Primary Completion Date: December 30, 2019
• Actual Study Completion Date: December 31, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Visual stimulation; Early visual stimulation (EVS) will be implemented by caregivers. Three phases: 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; the caregivers will present visual contrast cards at a distance of 15-20 centimetres; 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; Early visual stimulation; Other: standard care; standard care
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; standard care

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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)

Eligibility Criteria

• Ages Eligible for Study: 1 Month to 2 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Brazil

Universidade Federal de Santa Catarina

Araranguá, Santa Catarina, Brazil, 88.906-072

Sponsors and Collaborators

Universidade Federal de Santa Catarina

More Information

• Responsible Party: Adriana Neves Dos Santos, Professor, Reseacher, Universidade Federal de Santa Catarina
• ClinicalTrials.gov Identifier: NCT03302000
• Other Study ID Numbers: UFSC-SIGPEX / 201610782
• First Posted: October 4, 2017
• Last Update Posted: June 23, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be available
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code
• Time Frame: Data will be available within one year of study completion

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Adriana Neves Dos Santos, Universidade Federal de Santa Catarina:

prematurity; sensory stimulation; rehabilitation; infant

Additional relevant MeSH terms:

Premature Birth; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications