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

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.

Completed

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Key information

Conditions

Retinopathy of Prematurity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Retinal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Brain malformations

Treatment and study plan

Infants hospitalized in health facilities performing Tele-expertise

Device

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

Time frame: 4 weeks in average

For infants born at or after 28WA
Cost of telemedicine

Time frame: 6 months after enrollment of the first patient

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

Agence Regionale de Sante d'Ile de France

Registry information

Official study title

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

Acronym: Dite-ROP

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Jun 6, 2014
Registry last updated: Oct 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed