39946-I Laser and Bevacizumab Treatment for Retinopathy of Prematurity
Last updated on April 2022Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 100
Exclusion Criteria
- 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.
- Have unilateral or Bilateral ROP Stage 4 or 5 ROP;
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 Criteria
- 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.
- Have unilateral or Bilateral ROP Stage 4 or 5 ROP;
Tracking Information
- NCT #
- NCT01993043
- Collaborators
- Not Provided
- Investigators
- Not Provided
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