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The Analysis of Association of Retinopathy of Prematurity, Gut Microbiome Profile, and Systemic Inflammation

NCT05144282 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 240

Last updated 2023-05-06

No results posted yet for this study

Summary

Study Aims

1. Understanding the gut microbiome profile in very low birth weight infants with or without ROP. The onset and aggravation of ROP and their relationship with gut microbiome will be examined.
2. Understanding the serum inflammatory cytokine profile in these infants and its relationship with the onset and progression of ROP. Their changes and association with the other systemic disorders such as NEC or RDS or sepsis will be explored.
3. Examiningthe associations amongmicrobiome profile and serum inflammatory cytokines and their relationship with ROP clinical features (prematurity without ROP, ROP without treatment, and ROP with treatment) in the study participant

Conditions

  • Retinopathy of Prematurity
  • Microbiome

Interventions

PROCEDURE

intravitreal injection of anti VEGF

The treatment for ROP was either primary intravitreal injection (IVI) of anti-vascular endothelial growth factor (anti-VEGF).

PROCEDURE

laser photocoagulation

The treatment for ROP was either primary laser photocoagulation.

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Wu WeiChi, M.D., PhD. · Chang Gung Memorial Hospital

Eligibility

Min Age
1 Day
Max Age
1 Week
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-15
Primary Completion
2023-07-31
Completion
2023-07-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05144282 on ClinicalTrials.gov