Preterm InfantNCT03302000
Visual Stimulation of Preterm Infants
A study testing Early Visual Stimulation in people with Preterm Infant, run by Universidade Federal de Santa Catarina at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 2 monthsHealthy volunteers can take part
- Conditions the study is for
- Preterm Infant
- What is being tested?
- Early Visual Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 2 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de Santa Catarina
Araranguá, Santa Catarina, 88.906-072
About this study
Official title: Early Visual Stimulation in Preterm Infants at Home From 0 to 3 Months
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
- Being tested
- Early Visual Stimulation, standard care
- Keywords
- prematurity, sensory stimulation, rehabilitation, infant
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Visual StimulationOther
Early visual stimulation
standard careOther
standard care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: change measure: first day - before intervention; after intervention at home (28 days)
Secondary outcomes (3)
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.
Measured: change measure: first day - before intervention; after intervention at home (28 days); at 6 months of corrected age
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.
Measured: change measure: first day - before intervention; after intervention at home (28 days)
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)
Measured: change measure: at 6 months of corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start1 Sep 2018
- Primary completion30 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2-arm, parallel-groups, pragmatic superiority randomised controlled trial. Allocation ratio will be 1:1
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Santa Catarina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adriana Neves Dos Santos, Universidade Federal de Santa Catarina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03302000
- Sponsor's protocol ID
- UFSC-SIGPEX / 201610782
- Status last verified
- Jun 2020
- First submitted
- 30 Sep 2017
- Last updated
- 23 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be available
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Visual Stimulation in Preterm Infants at Home From 0 to 3 Months
- ClinicalTrials.gov ID
- NCT03302000
- Acronym / sponsor ID
- UFSC-SIGPEX / 201610782
- Conditions
- Preterm Infant
- Keywords
- prematurity, sensory stimulation, rehabilitation, infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidade Federal de Santa CatarinaUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 4 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 2-arm, parallel-groups, pragmatic superiority randomised controlled trial. Allocation ratio will be 1:1
| Arm | Type | Receives |
|---|---|---|
| Visual stimulation | Experimental | Other: Early Visual Stimulation, Other: standard careEarly 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. |
| standard care | Other | Other: standard careCaregivers 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. |
Who may qualify
- Ages
- 1 month to 2 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Visual StimulationEarly visual stimulation | Other | Visual stimulation |
| standard carestandard care | Other | Visual stimulation, standard care |
Primary outcome
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.
3 secondary outcomes
Sensory profile
Time frame: change measure: first day - before intervention; after intervention at home (28 days); at 6 months of corrected age
Motor Development
Time frame: change measure: first day - before intervention; after intervention at home (28 days)
Motor Development
Time frame: change measure: at 6 months of corrected age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Visual Stimulation in people with Preterm Infant, run by Universidade Federal de Santa Catarina at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual function - alertness, fixation, attention, tracking (time frame: change measure: first day - before intervention; after intervention at home (28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2020; AzTrials last refreshed its copy on 27 Oct 2026.