Cost-effectiveness of Tele-expertise for Premature Infants for Retinopathy (Dite-ROP)

October 13, 2015 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

843

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Corbeil-Essonnes, France, 91100
        • Service de réanimation néonatale. Centre Hospitalier Sud Francilien
      • Paris, France, 75014
        • Service de réanimation néonatale. Maternité de Port-Royal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Infants hospitalized in neonatology unit

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Brain malformations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Exposed group, during Tele-expertise
Infants hospitalized in health facilities performing tele-expertise
Device: Infants hospitalized in health facilities performing Tele-expertise
Exposed group, Prior Tele-expertise
Infants hospitalized in health facilities performing Tele-expertise prior implementation of Tele-expertise
Control group, Prior Tele-expertise
Control group, during Tele-expertise
Infants hospitalized in health facilities not performing Tele-expertise while the exposed group use Tele-expertise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
4 weeks in average

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delay before the first screening of retinopathy
Time Frame: 4 weeks in average
For infants born at or after 28WA
4 weeks in average
Cost of telemedicine
Time Frame: 6 months after enrollment of the first patient
6 months after enrollment of the first patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Agence Regionale de Sante d'Ile de France

Investigators

  • Principal Investigator: Isabelle Durand-Zaleski, MD, PhD, DRCD URC Eco. Assistance Publique, Hôpitaux de Paris
  • Principal Investigator: Michele Granier, MD, Centre Hospitalier Sud Francilien

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

May 27, 2014

First Submitted That Met QC Criteria

June 4, 2014

First Posted (Estimate)

June 6, 2014

Study Record Updates

Last Update Posted (Estimate)

October 14, 2015

Last Update Submitted That Met QC Criteria

October 13, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TLM-DITEROP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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