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

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Brief Title

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

Official Title

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

Brief 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
    

Detailed Description

      Background In recent decades, severeretinopathy of prematurity (ROP) and the proportion of
      ROP needing treatment is increasing. These conditions are due to the fact that more premature
      infants now could surviveowing to the improvement in neonatology. Since ROP isa leading cause
      of blindness in children, how to deal with these severely affected eyes becomes a major
      challenge.

      In recent years, growing evidence support that exposure to infection and inflammation
      increases risk of ROP and these exposures are considered key contributors to the pathogenesis
      of ROP. These exposures, which are modifiable, have gained interest among researchers.

      The microbiome are symbiotic organisms living inside human bodies. They are most abundant in
      human gastrointestinal tracts and play a fundamental role in host inflammatory and immunity
      physiology. The gut microbiome is most extensively studied, and reports showed that they play
      a role not only in gastrointestinal inflammatory diseases, but also in extra-gastrointestinal
      conditions.

      Recent data have shown that microbiome changes may involve in the pathogenesisof ophthalmic
      diseasessuch as uveitis, but its role in ROP has not been explored. Since ROP is closely
      related to inflammation, and that the gut microbiome has a significant role in the modulation
      of both systemic and ocular inflammatory pathways, we are interested to know whether there is
      association between ROP, microbiome, and systemic inflammation. Whether the microbiome
      profile is different in ROP and no-ROP neonates is worth exploring. Also, it is important to
      see whether the onset of ROP is related to the systemic inflammation status. To the best of
      our knowledge, there are no report on such topic, therefore our current study is designed to
      answer this question.

      Methods Very low birth weight preterm infantsborn in our hospital from August 2020to July
      2023 will be enrolled into study. Infants who has major or congenital GI anomaly will be
      excluded. ROP screening protocol and categorization will follow the international standards.
      DNA will be extracted from the stool samples and underwent microbiome profiling either by 16S
      rRNA or shotgun metagenomic sequencing. Blood samples from the routine blood examinations
      will beanalyzed by an immunoassay to reveal the level of systemic inflammation (IL-1
      alpha/beta, IL-10, IL-13 and so on). Statistical analysis will be performed and the
      associations among ROP features, gut microbiome, and serum inflammatory cytokines will be
      explored.

      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
    


Study Type

Observational [Patient Registry]


Primary Outcome

Gut Microbiome


Condition

Retinopathy of Prematurity

Intervention

intravitreal injection of anti VEGF

Study Arms / Comparison Groups

 premature baby without ROP (Group 1)
Description:  ROP: retinopathy of prematurity

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

240

Start Date

August 1, 2020

Completion Date

July 31, 2023

Primary Completion Date

July 31, 2023

Eligibility Criteria

        Inclusion Criteria:

          -  All GA<37 weeks preterm infants with birth weight (BW) between 500 and 1500 grams born
             in Linkou of Chung Gung Memorial Hospital from August 2020 to July 2023 will be
             enrolled into study after obtaining informed consent from their parent within
             1-week-of-age.

        Exclusion Criteria:

          -  Preterm infants who has major or congenital gastrointestional (GI) anomaly (eg.
             trisomy 13, trisomy 18, esophageal or intestinal atresia, GI obstruction, meconium
             peritonitis with prenatal bowel perforation, etc.).
      

Gender

All

Ages

N/A - 1 Week

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Wu WeiChi, M.D., PhD., , 

Location Countries

Taiwan

Location Countries

Taiwan

Administrative Informations


NCT ID

NCT05144282

Organization ID

201902088A3


Responsible Party

Sponsor

Study Sponsor

Chang Gung Memorial Hospital


Study Sponsor

Wu WeiChi, M.D., PhD., Principal Investigator, Chang Gung Memorial Hospital


Verification Date

November 2021