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Registry for Severe ROP and Treatment on Visual Outcomes

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mednax Center for Research, Education and Quality
ClinicalTrials.gov Identifier:
NCT01559571
First received: February 28, 2012
Last updated: March 22, 2016
Last verified: March 2016
  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:


Further study details as provided by Mednax Center for Research, Education and Quality:

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 ]

Enrollment: 324
Study Start Date: May 2012
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 7 Days   (Child)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Indiana
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
United States, Nevada
Summerlin Hospital Medical Center
Las Vegas, Nevada, United States, 89144
Sponsors and Collaborators
Mednax Center for Research, Education and Quality
Investigators
Principal Investigator: Reese H Clark, MD Mednax Center for Research, Education and Quality
  More Information

Responsible Party: Mednax Center for Research, Education and Quality
ClinicalTrials.gov Identifier: NCT01559571     History of Changes
Other Study ID Numbers: PDX-01-011 
Study First Received: February 28, 2012
Last Updated: March 22, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Mednax Center for Research, Education and Quality:
Retinopathy of Prematurity

Additional relevant MeSH terms:
Retinal Diseases
Premature Birth
Retinopathy of Prematurity
Eye Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on September 29, 2016