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NCT02157727 Clinical Trial

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

Retinopathy of Prematurity Clinical Trial

— Dite-ROP  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02157727
Other study ID # TLM-DITEROP
Secondary ID
Status Completed
Phase N/A
First received May 27, 2014
Last updated October 13, 2015
Start date January 2014
Est. completion date October 2015

Study information
Verified date October 2015
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 843
Est. completion date October 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Brain malformations

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• Infants hospitalized in health facilities performing Tele-expertise

Locations
Country Name City State
France Service de réanimation néonatale. Centre Hospitalier Sud Francilien Corbeil-Essonnes
France Service de réanimation néonatale. Maternité de Port-Royal Paris

Sponsors (2)
Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris Agence Regionale de Sante d'Ile de France

Country where clinical trial is conducted

France, 

References & Publications (2)

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. Review. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Delay before the first screening of retinopathy For infants born at or after 28WA 4 weeks in average No
Secondary Cost of telemedicine 6 months after enrollment of the first patient No
See also
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Completed NCT04838665 - Changes in Vital Signs and Pupil Diameter Related to Pharmacologic Mydriasis in Premature Infants: A Randomized Double Blind Clinical Study Phase 4
Completed NCT04408807 - Stress Induced by Screening for Retinopathy of Prematurity - Should Speculum and Indentation Rather be Avoided N/A
Recruiting NCT03083431 - Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity Phase 2
Enrolling by invitation NCT04985448 - Real World Study of the Effectiveness and Safety of Conbercept Ophthalmic Injection in the Treatment of Retinopathy of Prematurity - Multicenter, Retrospective and Observational Study Based on Real World Data
Recruiting NCT02090322 - Bevacizumab 0.500MG Intravitreal There Isn't Lower Than 0.625MG in the Treatment of ROP Type 1 N/A
Completed NCT00872664 - Skin and Serum Carotenoids in Preterm Infants Fed on a Formula Supplemented With Carotenoids N/A
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Completed NCT06452524 - Prematurity and Ophthalmological Changes
Completed NCT04101721 - Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity Phase 3
Enrolling by invitation NCT02050971 - Autologous Cord Blood Infusion for the Prevention and Treatment of Prematurity Complications In Preterm Neonates Phase 1
Terminated NCT01335113 - A Scan Ultrasonography in the Evaluation of Retinopathy of Prematurity
Active, not recruiting NCT00027222 - The Early Treatment for Retinopathy of Prematurity Study (ETROP) Phase 2/Phase 3
Recruiting NCT06109285 - Validation of i-ROP DL to Detect More Than Mild ROP N/A
Completed NCT02014454 - Safety and Efficacy of Propranolol Eye Drops in Treating Retinopathy of Premature Phase 2
Completed NCT01861470 - REDEXAM - Reducing Painful Eye Examinations in Preterm Infants N/A
Terminated NCT00634972 - Efficient Study of ACULAR in Inhibiting Proliferative Retinopathy in Prematurity Phase 4
Completed NCT05701124 - Intravitreal Ranibizumab Injection for Aggressive Versus Type 1 Prethreshold Retinopathy of Prematurity Phase 3
Completed NCT04092127 - Pain of Premature Babies and RetCam (DOLICAM)
Completed NCT04621136 - PhaseI/II Investigator-Initiated Trial to Investigate Safety and Efficacy of Ripasudil in Patients With Retinopathy of Prematurity Phase 1/Phase 2

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