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CompletedNCT02157727Dite-ROPUpdated Oct 14, 2015

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

An observational study in Retinopathy of Prematurity, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 2 sites in France. Per ClinicalTrials.gov, last updated 2015-10-14.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
843
Sex
All
01

Study 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.

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Conditions studied

  • Retinopathy of Prematurity
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In context

Retinal Diseases

815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.

This study's enrollment of 843 is above the median of 180 across 282 observational studies indexed under Retinal Diseases.

Browse Retinal Diseases studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Infants hospitalized in neonatology unit

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Brain malformations
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
843 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • DeviceInfants hospitalized in health facilities performing Tele-expertise
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What researchers measure

Primary outcomes

  1. Proportion of premature infants being screened for retinopathy following recommendations

    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)

    Time frame: 4 weeks in average

Secondary outcomes

  1. Delay before the first screening of retinopathy

    For infants born at or after 28WA

    Time frame: 4 weeks in average

  2. Cost of telemedicine

    Time frame: 6 months after enrollment of the first patient

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Study locations

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

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. PubMed 22617736 ↗
  • 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. PubMed 23277315 ↗
  • 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. PubMed 26857558 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02157727
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Agence Regionale de Sante d'Ile de France
Responsible party
Sponsor
First posted
Jun 6, 2014
Start date
Jan 2014
Primary completion
Jun 2015
Completion
Oct 2015
Last update
Oct 14, 2015

Study contacts

Isabelle Durand-Zaleski, MD, PhD
principal investigator · DRCD URC Eco. Assistance Publique, Hôpitaux de Paris
Michele Granier, MD
principal investigator · Centre Hospitalier Sud Francilien

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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