Retinopathy of PrematurityNCT05144282
The Analysis of Association of Retinopathy of Prematurity, Gut Microbiome Profile, and Systemic Inflammation
An observational study of Retinopathy of Prematurity and Microbiome, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 1 day to 1 weekHealthy volunteers can take part
- Conditions the study is for
- Retinopathy of Prematurity, Microbiome
- What is being tested?
- intravitreal injection of anti VEGF and laser photocoagulation
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 240 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Aug 2020to 31 Jul 2023
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 1 week
- All sexes
- Healthy volunteers accepted
- Child
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Ophthalmology, Chang Gung Memorial Hospital.
Taoyuan, Linkou, 33305
About this study
Study Aims
- 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.
- 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.
- 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
Read the 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
- 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.
- 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.
- 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
- Being tested
- intravitreal injection of anti VEGF, laser photocoagulation
- Keywords
- Retinopathy of prematurity, microbiome, very low birth weight, inflammatory cytokine
- Medical subject headings
- Retinopathy of Prematurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravitreal injection of anti VEGFProcedure or surgery
The treatment for ROP was either primary intravitreal injection (IVI) of anti-vascular endothelial growth factor (anti-VEGF).
laser photocoagulationProcedure or surgery
The treatment for ROP was either primary laser photocoagulation.
| Study group | Role | What they receive |
|---|---|---|
| premature baby without ROP (Group 1) | ROP: retinopathy of prematurity | |
| ROP without treatment (Group 2) | ROP: retinopathy of prematurity | |
| ROP with anti-VEGF treatment (Group 3) | ROP: retinopathy of prematurity Receives: Procedure: intravitreal injection of anti VEGF | |
| ROP with laser photocoagulation treatment (Group 4) | ROP: retinopathy of prematurity Receives: Procedure: laser photocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut Microbiome
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.
Measured: 2020-2023
Serum Inflammatory Cytokine
Understanding the serum inflammatory cytokine profile in these high-risk 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.
Measured: 2020-2023
Microbiome Profile And Serum Inflammatory Cytokines And Their Relationship with ROP
Examining the associations among microbiome profile and serum inflammatory cytokines and their relationship with ROP clinical features in the study participants (patients with prematurity without ROP, patients with ROP without treatment, and patients with ROP and treatment).
Measured: 2020-2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start15 Aug 2020
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinopathy of PrematurityStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wu WeiChi, M.D., PhD., Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144282
- Sponsor's protocol ID
- 201902088A3
- Status last verified
- May 2023
- First submitted
- 22 Nov 2021
- Last updated
- 6 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analysis of Association of Retinopathy of Prematurity, Gut Microbiome Profile, and Systemic Inflammation
- ClinicalTrials.gov ID
- NCT05144282
- Acronym / sponsor ID
- 201902088A3
- Conditions
- Retinopathy of Prematurity, Microbiome
- Keywords
- Retinopathy of prematurity, microbiome, very low birth weight, inflammatory cytokine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Aims
- 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.
- 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.
- 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
- 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.
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| premature baby without ROP (Group 1) | – | –ROP: retinopathy of prematurity |
| ROP without treatment (Group 2) | – | –ROP: retinopathy of prematurity |
| ROP with anti-VEGF treatment (Group 3) | – | Procedure: intravitreal injection of anti VEGFROP: retinopathy of prematurity |
| ROP with laser photocoagulation treatment (Group 4) | – | Procedure: laser photocoagulationROP: retinopathy of prematurity |
Who may qualify
- Ages
- 1 day to 1 week
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravitreal injection of anti VEGFThe treatment for ROP was either primary intravitreal injection (IVI) of anti-vascular endothelial growth factor (anti-VEGF). | Procedure or surgery | ROP with anti-VEGF treatment (Group 3) |
| laser photocoagulationThe treatment for ROP was either primary laser photocoagulation. | Procedure or surgery | ROP with laser photocoagulation treatment (Group 4) |
Primary outcome
Gut Microbiome
Time frame: 2020-2023
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.
Serum Inflammatory Cytokine
Time frame: 2020-2023
Understanding the serum inflammatory cytokine profile in these high-risk 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.
Microbiome Profile And Serum Inflammatory Cytokines And Their Relationship with ROP
Time frame: 2020-2023
Examining the associations among microbiome profile and serum inflammatory cytokines and their relationship with ROP clinical features in the study participants (patients with prematurity without ROP, patients with ROP without treatment, and patients with ROP and treatment).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wu WeiChi, M.D., PhD. principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinopathy of Prematurity and Microbiome, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut Microbiome (time frame: 2020-2023). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.