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In This Section Texas Health Research & Education Institute

Clinical Trials

Disease or Condition   Retinopathy of Prematurity (ROP)
Title   Registry Study for Severe Retinopathy and Treatment on Visual Outcomes of Premature Neonates (ROP Study)
Description   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.
IRB Number   Pro3289
Inclusion/Notes   INCLUSION:
  • Documentation of informed consent and authorization form. Informed consent will be obtained from the parent or legal guardian by the Principal Investigator and/or designated research staff. Parent must provide contact information to obtain follow-up data on their child.

  • 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 (inborn error of metabolism, chromosomal abnormalities, cyanotic congenital heart disease, gastroschisis, omphalocele, diaphragmatic hernia or other major gastrointestinal anomalies, major neurological injury or anomaly, congenital anomalies of the eye, and multiple congenital anomalies).

EXCLUSION:
  • ROP stage 1 or less.

  • Parents unwilling to participate in follow-up.

  • Major congenital anomalies (inborn error of metabolism, chromosomal abnormalities, cyanotic congenital heart disease, gastroschisis, omphalocele, diaphragmatic hernia or other major gastrointestinal anomalies, major neurological injury or anomaly, congenital anomalies of the eye, and multiple congenital anomalies).
Status   Recruiting
Location   Texas Health Presbyterian Hospital Dallas
Contact Name   Julie McCracken
Phone   (214) 345-1886

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