Registry for Severe ROP and Treatment on Visual Outcomes

NCT ID: NCT01559571

Last Updated: 2020-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

324 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2020-05-15

Brief Summary

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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.

Detailed Description

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Conditions

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Retinopathy of Prematurity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* ROP stage 1 or less
* Parents unwilling to participate in follow-up
* Major congenital anomalies
Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pediatrix

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Reese H Clark, MD

Role: PRINCIPAL_INVESTIGATOR

Pediatrix

Locations

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Memorial Hospital of South Bend

South Bend, Indiana, United States

Site Status

Summerlin Hospital Medical Center

Las Vegas, Nevada, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 31480086 (View on PubMed)

Other Identifiers

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PDX-01-011

Identifier Type: -

Identifier Source: org_study_id

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