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Clinical Trials/NCT02157727
NCT02157727
Completed
Not Applicable

Effectiveness and Cost-effectiveness of Tele-expertise for the Screening Examination of Premature Infants for Retinopathy of Prematurity

Assistance Publique - Hôpitaux de Paris2 sites in 1 country843 target enrollmentJanuary 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Retinopathy of Prematurity
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
843
Locations
2
Primary Endpoint
Proportion of premature infants being screened for retinopathy following recommendations
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

The purpose of this study is to determine whether telemedicine would be as effective as having a pediatrics ophthalmologist on site for screening examination of retinopathy in premature infants and would be cost-effective.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
October 2015
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Born before 32 WA or having a birth weight under 1500g

Exclusion Criteria

  • Brain malformations

Outcomes

Primary Outcomes

Proportion of premature infants being screened for retinopathy following recommendations

Time Frame: 4 weeks in average

Proportion of premature infants being screened for retinopathy following recommendations (between 31 and 32 weeks of amenorrhea (WA) for infants born before 28 WA and during the fourth week of life for infants born after 28 WA)

Secondary Outcomes

  • Delay before the first screening of retinopathy(4 weeks in average)
  • Cost of telemedicine(6 months after enrollment of the first patient)

Study Sites (2)

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