Retinopathy of PrematurityNCT01559571
Registry for Severe ROP and Treatment on Visual Outcomes
An observational study of Retinopathy of Prematurity, run by Pediatrix at 2 sites in United States.
Trial summary
The purpose of this study is to determine what factors influence the visual outcomes of infants with severe retinopathy of prematurity (ROP) and to monitor the outcomes. Read more about this study
- Who is it for?
- Ages Up to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Retinopathy of Prematurity
- How many people
- 324 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2012to 15 May 2020
- 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 Up to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Neonates who have a diagnosis of Retinopathy of Prematurity Stage 2 or higher
Who may be able to join
- Documentation of informed consent and authorization
- Inborn and those admitted within 7 days of birth
- Infant with a diagnosis of stage 2 ROP or higher
- Site ability to plan close ophthalmological follow-up due to significant and persistent ROP
- Parents must agree to report outcomes following each ophthalmological visit and overall outcomes for up to five (5) years of age
- Ability to obtain follow-up data on outcomes if the child is transferred to another facility
- No known major congenital anomalies
Who cannot join
- ROP stage 1 or less
- Parents unwilling to participate in follow-up
- Major congenital anomalies
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144
Memorial Hospital of South Bend
South Bend, Indiana, 46601
About this study
Official title: Study Registry for Severe Retinopathy and Treatment on Visual Outcomes of Premature Neonates
The purpose of this study is to determine what factors influence the visual outcomes of infants with severe retinopathy of prematurity (ROP) and to monitor the outcomes.
- Conditions
- Retinopathy of Prematurity
- Keywords
- Retinopathy of Prematurity
- Medical subject headings
- Retinopathy of Prematurity
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of visual acuity in subjects who were treated for ROP
Measured: Five year follow-up
Secondary outcomes (1)
Recurrence of stage 3+ retinopathy of prematurity in one or both eyes in zone I or posterior zone II Recurrence of stage 3+ retinopathy of prematurity in one or both eyes in zone I or posterior zone II
Measured: Five year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study startMay 2012
- Primary completion15 May 2020
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinopathy of PrematurityStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pediatrix
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reese H Clark, MD, Principal investigator, Pediatrix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559571
- Sponsor's protocol ID
- PDX-01-011
- Status last verified
- Jun 2020
- First submitted
- 28 Feb 2012
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Tolia VN, Ahmad KA, Jacob J, Kelleher AS, McLane N, Arnold RW, Clark RH; MEDNAX ROP Registry Investigators. Two-Year Outcomes of Infants with Stage 2 or Higher Retinopathy of Prematurity: Results from a Large Multicenter Registry. Am J Perinatol. 2020 Jan;37(2):196-203. doi: 10.1055/s-0039-1694983. Epub 2019 Sep 3.
PubMed 31480086
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Registry for Severe Retinopathy and Treatment on Visual Outcomes of Premature Neonates
- ClinicalTrials.gov ID
- NCT01559571
- Acronym / sponsor ID
- PDX-01-011
- Conditions
- Retinopathy of Prematurity
- Keywords
- Retinopathy of Prematurity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- PediatrixUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 21 Mar 2012 (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 what factors influence the visual outcomes of infants with severe retinopathy of prematurity (ROP) and to monitor the outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Neonates who have a diagnosis of Retinopathy of Prematurity Stage 2 or higher
Key inclusion criteria (7 listed)
- Documentation of informed consent and authorization
- Inborn and those admitted within 7 days of birth
- Infant with a diagnosis of stage 2 ROP or higher
- Site ability to plan close ophthalmological follow-up due to significant and persistent ROP
- Parents must agree to report outcomes following each ophthalmological visit and overall outcomes for up to five (5) years of age
Key exclusion criteria (3 listed)
- ROP stage 1 or less
- Parents unwilling to participate in follow-up
- Major congenital anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of visual acuity in subjects who were treated for ROP
Time frame: Five year follow-up
1 secondary outcome
Recurrence of stage 3+ retinopathy of prematurity in one or both eyes in zone I or posterior zone II Recurrence of stage 3+ retinopathy of prematurity in one or both eyes in zone I or posterior zone II
Time frame: Five year follow-up
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 30 Jun 2020.
- Derived from this study: PubMed 31480086Tolia VN, Ahmad KA, Jacob J, Kelleher AS, McLane N, Arnold RW, Clark RH; MEDNAX ROP Registry Investigators. Two-Year Outcomes of Infants with Stage 2 or Higher Retinopathy of Prematurity: Results from a Large Multicenter Registry. Am J Perinatol. 2020 Jan;37(2):196-203. doi: 10.1055/s-0039-1694983. Epub 2019 Sep 3.
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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.
Reese H Clark, MD principal investigator
Pediatrix
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 Pediatrix at 2 sites in United States.
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 7 inclusion and 3 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 30 Jun 2020. 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 United States. 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?
Identification of visual acuity in subjects who were treated for ROP (time frame: Five year follow-up). 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 NCT01559571, which also lists 1 linked publication.
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 30 Jun 2020.