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Registry for Severe ROP and Treatment on Visual Outcomes

This study is currently recruiting participants.
Verified May 2013 by Pediatrix Medical Group
Sponsor:
Information provided by (Responsible Party):
Pediatrix Medical Group
ClinicalTrials.gov Identifier:
NCT01559571
First received: February 28, 2012
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition
Retinopathy of Prematurity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study Registry for Severe Retinopathy and Treatment on Visual Outcomes of Premature Neonates

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pediatrix Medical Group:

Primary Outcome Measures:
  • Identification of visual acuity in subjects who were treated for ROP [ Time Frame: Five year follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: May 2012
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Neonates who have a diagnosis of Retinopathy of Prematurity Stage 2 or higher

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01559571

Contacts
Contact: Amy Kelleher, MSHS amy_kelleher@pediatrix.com

Locations
United States, Indiana
Memorial Hospital of South Bend Recruiting
South Bend, Indiana, United States, 46601
Contact: Robert White, MD         robert_white@pediatrix.com    
United States, Nevada
Summerlin Hospital Medical Center Not yet recruiting
Las Vegas, Nevada, United States, 89144
Contact: Bradlee Drabant, MD         bradley_drabant@pediatrix.com    
Principal Investigator: Bradlee Drabant, MD            
Sponsors and Collaborators
Pediatrix Medical Group
Investigators
Principal Investigator: Reese H Clark, MD Pediatrix Medical Group
  More Information

No publications provided

Responsible Party: Pediatrix Medical Group
ClinicalTrials.gov Identifier: NCT01559571     History of Changes
Other Study ID Numbers: PDX-01-011
Study First Received: February 28, 2012
Last Updated: May 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Pediatrix Medical Group:
Retinopathy of Prematurity

Additional relevant MeSH terms:
Retinal Diseases
Retinopathy of Prematurity
Eye Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on May 23, 2013