Status:

COMPLETED

Visual Stimulation of Preterm Infants

Lead Sponsor:

Universidade Federal de Santa Catarina

Conditions:

Preterm Infant

Eligibility:

All Genders

1-2 years

Phase:

NA

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 functi...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

September 1 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 31 2019

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT03302000

Start Date

September 1 2018

End Date

December 31 2019

Last Update

June 23 2020

Active Locations (1)

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Universidade Federal de Santa Catarina

Araranguá, Santa Catarina, Brazil, 88.906-072