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

NCT ID: NCT02157727

Last Updated: 2015-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

843 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-10-31

Brief Summary

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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

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Conditions

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Retinopathy of Prematurity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Exposed group, during Tele-expertise

Infants hospitalized in health facilities performing tele-expertise

Infants hospitalized in health facilities performing Tele-expertise

Intervention Type DEVICE

Exposed group, Prior Tele-expertise

Infants hospitalized in health facilities performing Tele-expertise prior implementation of Tele-expertise

No interventions assigned to this group

Control group, Prior Tele-expertise

No interventions assigned to this group

Control group, during Tele-expertise

Infants hospitalized in health facilities not performing Tele-expertise while the exposed group use Tele-expertise

No interventions assigned to this group

Interventions

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Infants hospitalized in health facilities performing Tele-expertise

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Brain malformations
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agence Regionale de Sante d'Ile de France

OTHER_GOV

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Isabelle Durand-Zaleski, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

DRCD URC Eco. Assistance Publique, Hôpitaux de Paris

Michele Granier, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Sud Francilien

Locations

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Service de réanimation néonatale. Centre Hospitalier Sud Francilien

Corbeil-Essonnes, , France

Site Status

Service de réanimation néonatale. Maternité de Port-Royal

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 22617736 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23277315 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26857558 (View on PubMed)

Related Links

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Other Identifiers

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TLM-DITEROP

Identifier Type: -

Identifier Source: org_study_id

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