<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03302000</url>
  </required_header>
  <id_info>
    <org_study_id>UFSC-SIGPEX / 201610782</org_study_id>
    <nct_id>NCT03302000</nct_id>
  </id_info>
  <brief_title>Visual Stimulation of Preterm Infants</brief_title>
  <official_title>Early Visual Stimulation in Preterm Infants at Home From 0 to 3 Months</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal de Santa Catarina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal de Santa Catarina</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Introduction: Prematurity rate has increased and is a risk factor for developmental delay.&#xD;
      Preterm infants with low visual tracking might present deficits in cognition, language, and&#xD;
      fine motor function in future ages. Few studies applied home stimulation of the visual system&#xD;
      for preterm infant (PT) at an early age.&#xD;
&#xD;
      Objective: To compare the effects of early visual stimulation to a standard care group in&#xD;
      visual function, motor and sensory development.&#xD;
&#xD;
      Methods: Randomized controlled trial. At home setting. Thirty healthy preterm infants,&#xD;
      gestational age from 28 to 37 weeks, aged from one to two months of corrected age at the&#xD;
      entrance of the study, with low visual function, will be evaluated. Participants will be&#xD;
      randomly allocated to: (1) a standard care group, receiving orientation about general sensory&#xD;
      and motor development, (2) an early visual stimulation group receiving a 4-week home based&#xD;
      protocol applied by caregivers additional to standard care. Outcomes will be measured at&#xD;
      before the beginning of stimulation, at the end of stimulation and at 6 months of corrected&#xD;
      age. Primary outcome is visual function evaluated by ML Leonhardt Battery of Optotypes.&#xD;
      Secondary outcomes include motor and sensory development evaluated by scales.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>2-arm, parallel-groups, pragmatic superiority randomised controlled trial. Allocation ratio will be 1:1</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Visual function - alertness, fixation, attention, tracking</measure>
    <time_frame>change measure: first day - before intervention; after intervention at home (28 days)</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensory profile</measure>
    <time_frame>change measure: first day - before intervention; after intervention at home (28 days); at 6 months of corrected age</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor Development</measure>
    <time_frame>change measure: first day - before intervention; after intervention at home (28 days)</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor Development</measure>
    <time_frame>change measure: at 6 months of corrected age</time_frame>
    <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)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Preterm Infant</condition>
  <arm_group>
    <arm_group_label>Visual stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Early visual stimulation (EVS) will be implemented by caregivers.&#xD;
Three phases:&#xD;
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&#xD;
the caregivers will present visual contrast cards at a distance of 15-20 centimetres&#xD;
the caregiver will present two toys to the infant&#xD;
Stimulation will last for 28 days (4 weeks) in total, one time a day for 10-15 minutes, all days week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>standard care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Early Visual Stimulation</intervention_name>
    <description>Early visual stimulation</description>
    <arm_group_label>Visual stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>standard care</intervention_name>
    <description>standard care</description>
    <arm_group_label>Visual stimulation</arm_group_label>
    <arm_group_label>standard care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  gestational age between 28 and 37 weeks&#xD;
&#xD;
          -  age at enrolment between one to two months of corrected age t&#xD;
&#xD;
          -  absence of visual impairments evaluated with Red Reflex Examination and complete&#xD;
             ophthalmology exam, which will be performed by a doctor at the hospital or the basic&#xD;
             health units where the infants will be recruited&#xD;
&#xD;
          -  infants at home&#xD;
&#xD;
          -  presence of low acuity assessed by the ML-Leonhardt Optotypes Battery (absence of&#xD;
             alertness, fixation and attention in at least three cards, or visual tracking&#xD;
             classified as absent or brief for more than three cards)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  presence of any diagnosed neurological diseases&#xD;
&#xD;
          -  presence of diagnosed respiratory diseases&#xD;
&#xD;
          -  hypoxemia, hyperventilation or hypo-ventilation during assessments&#xD;
&#xD;
          -  presence of congenital diseases&#xD;
&#xD;
          -  presence of diagnosed visual impairments, such as blindness or low vision&#xD;
&#xD;
          -  extreme premature, ie, with gestation age bellow 28 weeks due to higher risk of&#xD;
             retinopathy of prematurity&#xD;
&#xD;
          -  birth weight less than 1,000 grams due to higher risk of retinopathy of prematurity&#xD;
&#xD;
          -  absence of alertness according with Precthl and Beintema&#xD;
&#xD;
          -  preterm infant with unstable physiological conditions&#xD;
&#xD;
          -  preterm infant receiving any kind of intervention such as physical therapy,&#xD;
             occupational therapy, early intervention, aquatic stimulation, at the same time that&#xD;
             our stimulation protocol is being applied since they can be confounders&#xD;
&#xD;
          -  infants with medical fragility that prevent them to participate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>2 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Universidade Federal de Santa Catarina</name>
      <address>
        <city>Araranguá</city>
        <state>Santa Catarina</state>
        <zip>88.906-072</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>September 30, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>June 22, 2020</last_update_submitted>
  <last_update_submitted_qc>June 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal de Santa Catarina</investigator_affiliation>
    <investigator_full_name>Adriana Neves Dos Santos</investigator_full_name>
    <investigator_title>Professor, Reseacher</investigator_title>
  </responsible_party>
  <keyword>prematurity</keyword>
  <keyword>sensory stimulation</keyword>
  <keyword>rehabilitation</keyword>
  <keyword>infant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual participant data for all primary and secondary outcome measures will be available</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data will be available within one year of study completion</ipd_time_frame>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03302000
org study id: UFSC-SIGPEX / 201610782
nct id: NCT03302000
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 2-arm, parallel-groups, pragmatic superiority randomised controlled trial. Allocation ratio will be 1:1
primary purpose: Prevention
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.
measure: Visual function - alertness, fixation, attention, tracking
time frame: change measure: first day - before intervention; after intervention at home (28 days)
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.
measure: Sensory profile
time frame: change measure: first day - before intervention; after intervention at home (28 days); at 6 months of corrected age
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.
measure: Motor Development
time frame: change measure: first day - before intervention; after intervention at home (28 days)
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.
measure: Motor Development
time frame: change measure: at 6 months of corrected age
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)
arm group label: Visual stimulation
arm group type: Experimental
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 group label: standard care
arm group type: Other
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: Early Visual Stimulation
description: Early visual stimulation
arm group label: Visual stimulation
intervention type: Other
intervention name: standard care
description: standard care
arm group label: Visual stimulation
arm group label: standard care
criteria: 
gender: All
minimum age: 1 Month
maximum age: 2 Months
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal de Santa Catarina
investigator full name: Adriana Neves Dos Santos
investigator title: Professor, Reseacher
mesh term: Premature Birth
sharing ipd: Yes
ipd description: De-identified individual participant data for all primary and secondary outcome measures will be available
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Data will be available within one year of study completion