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