NCT02157727

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
843

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 6, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 14, 2015

Status Verified

October 1, 2015

Enrollment Period

1.4 years

First QC Date

May 27, 2014

Last Update Submit

October 13, 2015

Conditions

Retinopathy of Prematurity

Outcome Measures

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)

    4 weeks in average

Secondary Outcomes (2)

  • Delay before the first screening of retinopathy

    4 weeks in average

  • Cost of telemedicine

    6 months after enrollment of the first patient

Study Arms (4)

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

Infants hospitalized in health facilities performing Tele-expertiseDEVICE
Exposed group, during Tele-expertise

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Infants hospitalized in neonatology unit

You may qualify if:

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

You may not qualify if:

  • Brain malformations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Service de réanimation néonatale. Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91100, France

Location

Service de réanimation néonatale. Maternité de Port-Royal

Paris, 75014, France

Location

Related Publications (3)

  • 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.

    PMID: 22617736BACKGROUND

  • 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.

    PMID: 23277315BACKGROUND

  • 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.

    PMID: 26857558DERIVED

Related Links

MeSH Terms

Conditions

Retinopathy of Prematurity

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Isabelle Durand-Zaleski, MD, PhD

    DRCD URC Eco. Assistance Publique, Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

  • Michele Granier, MD

    Centre Hospitalier Sud Francilien

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2014

First Posted

June 6, 2014

Study Start

January 1, 2014

Primary Completion

June 1, 2015

Study Completion

October 1, 2015

Last Updated

October 14, 2015

Record last verified: 2015-10

Locations

FR(2)