- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02157727
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
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Corbeil-Essonnes, France, 91100
- Service de réanimation néonatale. Centre Hospitalier Sud Francilien
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Paris, France, 75014
- Service de réanimation néonatale. Maternité de Port-Royal
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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
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Exposed group, Prior Tele-expertise
Infants hospitalized in health facilities performing Tele-expertise prior implementation of Tele-expertise
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Control group, Prior Tele-expertise
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Control group, during Tele-expertise
Infants hospitalized in health facilities not performing Tele-expertise while the exposed group use Tele-expertise
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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
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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)
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4 weeks in average
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Delay before the first screening of retinopathy
Time Frame: 4 weeks in average
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For infants born at or after 28WA
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4 weeks in average
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Cost of telemedicine
Time Frame: 6 months after enrollment of the first patient
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6 months after enrollment of the first patient
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
- Kidholm K, Ekeland AG, Jensen LK, Rasmussen J, Pedersen CD, Bowes A, Flottorp SA, Bech M. A model for assessment of telemedicine applications: mast. Int J Technol Assess Health Care. 2012 Jan;28(1):44-51. doi: 10.1017/S0266462311000638.
- Charrier N, Zarca K, Durand-Zaleski I, Calinaud C; ARS Ile de France telemedicine group. Efficacy and cost effectiveness of telemedicine for improving access to care in the Paris region: study protocols for eight trials. BMC Health Serv Res. 2016 Feb 8;16:45. doi: 10.1186/s12913-016-1281-1.
- Fierson WM; American Academy of Pediatrics Section on Ophthalmology; American Academy of Ophthalmology; American Association for Pediatric Ophthalmology and Strabismus; American Association of Certified Orthoptists. Screening examination of premature infants for retinopathy of prematurity. Pediatrics. 2013 Jan;131(1):189-95. doi: 10.1542/peds.2012-2996. Epub 2012 Dec 31.
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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