Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
100

Exclusion Criterias

Have unilateral or Bilateral ROP Stage 4 or 5 ROP;
Lack of signed consent by the parent or legal guardian.
Have unilateral or Bilateral ROP Stage 4 or 5 ROP;
Lack of signed consent by the parent or legal guardian.

Summary

Conditions
Focus of the Study is to Evaluate the Efficacy and Safety of Bevacizumab for the Treatment of ROP
Design
  • Observational Model: Cohort
  • Time Perspective: Prospective

Participation Requirements

Age
Younger than 3040 years
Gender
Both males and females

Description

This study will enroll preterm infants who were scheduled to receive treatment for ROP by laser or Bevacizumab. We will observe the patients in the hospital for the cure of ROP until 54 weeks' postmenstrual age. We will check the changes of chemicals in the blood and observe short-term and long-term...

This study will enroll preterm infants who were scheduled to receive treatment for ROP by laser or Bevacizumab. We will observe the patients in the hospital for the cure of ROP until 54 weeks' postmenstrual age. We will check the changes of chemicals in the blood and observe short-term and long-term effects on visual system, brain and other body organs. Descriptive statistics from a two sample t-test or Fisher's exact test will be used to compare the short and long-term vision and neurological development outcomes. We predefined a statistical significance level p=0.05.

Exclusion Criterias

Have unilateral or Bilateral ROP Stage 4 or 5 ROP;
Lack of signed consent by the parent or legal guardian.
Have unilateral or Bilateral ROP Stage 4 or 5 ROP;
Lack of signed consent by the parent or legal guardian.

Locations

Houston, Texas, 77030
Lubbock, Texas, 79430
Houston, Texas, 77030
Lubbock, Texas, 79430

Tracking Information

NCT #
NCT01993043
Collaborators
Not Provided
Investigators
Not Provided