Cost-effectiveness of Tele-expertise for Premature Infants for Retinopathy

Completed

• Conditions: Retinopathy of Prematurity
• Interventions: Device: Infants hospitalized in health facilities performing Tele-expertise

• Registration Number: NCT02157727
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-05-27
• Study First Submitted QC: 2014-06-04
• Study First Posted: 2014-06-06
• Primary Completion: 2015-06
• Status Verified: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2015-10-13
• Last Update Posted: 2015-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 843

Inclusion Criteria

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

Exclusion Criteria

• Brain malformations

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exposed group, during Tele-expertise	Infants hospitalized in health facilities performing Tele-expertise	Infants hospitalized in health facilities performing tele-expertise

Primary Outcome Measures

Name	Time	Method
Proportion of premature infants being screened for retinopathy following recommendations	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 Outcome Measures

Name	Time	Method
Cost of telemedicine	6 months after enrollment of the first patient
Delay before the first screening of retinopathy	4 weeks in average	For infants born at or after 28WA

Trial Locations

Locations (2)

Service de réanimation néonatale. Centre Hospitalier Sud Francilien; 🇫🇷 Corbeil-Essonnes, France

Service de réanimation néonatale. Maternité de Port-Royal; 🇫🇷 Paris, France