search
Back to results

Visual Stimulation of Preterm Infants

Primary Purpose

Preterm Infant

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Early Visual Stimulation
standard care
Sponsored by
Universidade Federal de Santa Catarina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Infant focused on measuring prematurity, sensory stimulation, rehabilitation, infant

Eligibility Criteria

1 Month - 2 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Universidade Federal de Santa Catarina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Visual stimulation

standard care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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)

Full Information

First Posted
September 30, 2017
Last Updated
June 22, 2020
Sponsor
Universidade Federal de Santa Catarina
search

1. Study Identification

Unique Protocol Identification Number
NCT03302000
Brief Title
Visual Stimulation of Preterm Infants
Official Title
Early Visual Stimulation in Preterm Infants at Home From 0 to 3 Months
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Santa Catarina

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infant
Keywords
prematurity, sensory stimulation, rehabilitation, infant

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2-arm, parallel-groups, pragmatic superiority randomised controlled trial. Allocation ratio will be 1:1
Masking
ParticipantCare ProviderInvestigator
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.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Visual stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
standard care
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Early Visual Stimulation
Intervention Description
Early visual stimulation
Intervention Type
Other
Intervention Name(s)
standard care
Intervention Description
standard care
Primary Outcome Measure Information:
Title
Visual function - alertness, fixation, attention, tracking
Description
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)
Secondary Outcome Measure Information:
Title
Sensory profile
Description
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
Title
Motor Development
Description
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)
Title
Motor Development
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
2 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Universidade Federal de Santa Catarina
City
Araranguá
State/Province
Santa Catarina
ZIP/Postal Code
88.906-072
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data for all primary and secondary outcome measures will be available
IPD Sharing Time Frame
Data will be available within one year of study completion

Learn more about this trial

Visual Stimulation of Preterm Infants

We'll reach out to this number within 24 hrs