Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05144282 |
| Other study ID # |
201902088A3 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 15, 2020 |
| Est. completion date |
July 31, 2023 |
Study information
| Verified date |
May 2023 |
| Source |
Chang Gung Memorial Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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
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
