Retinopathy of PrematurityDite-ROPNCT02157727
Cost-effectiveness of Tele-expertise for Premature Infants for Retinopathy
An observational study of Retinopathy of Prematurity, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retinopathy of Prematurity
- What is being tested?
- Infants hospitalized in health facilities performing Tele-expertise
- Type of treatment
- Medical device
- How many people
- 843 participants
- Where
- 2 sitesFrance
- Study dates
- Jan 2014to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Infants hospitalized in neonatology unit
Who may be able to join
- Born before 32 WA or having a birth weight under 1500g
Who cannot join
- Brain malformations
Trial locations and contacts
2 sites in 1 country.
France2 sites
Service de réanimation néonatale. Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91100
Service de réanimation néonatale. Maternité de Port-Royal
Paris, 75014
About this study
Official title: Effectiveness and Cost-effectiveness of Tele-expertise for the Screening Examination of Premature Infants for Retinopathy of Prematurity
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.
- Conditions
- Retinopathy of Prematurity
- Being tested
- Infants hospitalized in health facilities performing Tele-expertise
- Medical subject headings
- Retinopathy of Prematurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infants hospitalized in health facilities performing Tele-expertiseDevice
| Study group | Role | What they receive |
|---|---|---|
| Exposed group, during Tele-expertise | Infants hospitalized in health facilities performing tele-expertise Receives: 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 | Not described | |
| Control group, during Tele-expertise | Infants hospitalized in health facilities not performing Tele-expertise while the exposed group use Tele-expertise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 4 weeks in average
Secondary outcomes (2)
Delay before the first screening of retinopathy
For infants born at or after 28WA
Measured: 4 weeks in average
Cost of telemedicine
Measured: 6 months after enrollment of the first patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Retinopathy of PrematurityStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 843 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Agence Regionale de Sante d'Ile de France
- Responsible party
- Sponsor
- Investigators
- Isabelle Durand-Zaleski, MD, PhD, Principal investigator, DRCD URC Eco. Assistance Publique, Hôpitaux de ParisMichele Granier, MD, Principal investigator, Centre Hospitalier Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157727
- Sponsor's protocol ID
- TLM-DITEROP
- Acronym
- Dite-ROP
- Status last verified
- Oct 2015
- First submitted
- 27 May 2014
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
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 22617736Fierson 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 23277315Charrier 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Cost-effectiveness of Tele-expertise for the Screening Examination of Premature Infants for Retinopathy of Prematurity
- ClinicalTrials.gov ID
- NCT02157727
- Acronym / sponsor ID
- Dite-ROP / TLM-DITEROP
- Conditions
- Retinopathy of Prematurity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 843 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Agence Regionale de Sante d'Ile de France
- Study start
- Jan 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 6 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Exposed group, during Tele-expertise | – | Device: Infants hospitalized in health facilities performing Tele-expertiseInfants 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Infants hospitalized in neonatology unit
Key inclusion criteria (1 listed)
- Born before 32 WA or having a birth weight under 1500g
Key exclusion criteria (1 listed)
- Brain malformations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infants hospitalized in health facilities performing Tele-expertise | Device | Exposed group, during Tele-expertise |
Primary outcome
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)
2 secondary outcomes
Delay before the first screening of retinopathy
Time frame: 4 weeks in average
Cost of telemedicine
Time frame: 6 months after enrollment of the first patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
- Background: PubMed 22617736Kidholm 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.
- Background: PubMed 23277315Fierson 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.
- Derived from this study: PubMed 26857558Charrier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Durand-Zaleski, MD, PhD principal investigator
DRCD URC Eco. Assistance Publique, Hôpitaux de Paris
Michele Granier, MD principal investigator
Centre Hospitalier Sud Francilien
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinopathy of Prematurity, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of premature infants being screened for retinopathy following recommendations (time frame: 4 weeks in average). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02157727, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015.