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

NCT05144282 | Unknown

• 1 other identifier: 201902088A3
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Study Aims

1. 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. 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. 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

Keywords

Retinopathy of prematurity; microbiome; very low birth weight; inflammatory cytokine

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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).

  2020-2023

Study Arms (4)

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

Procedure: intravitreal injection of anti VEGF

ROP with laser photocoagulation treatment (Group 4)

ROP: retinopathy of prematurity

Procedure: laser photocoagulation

Interventions

intravitreal injection of anti VEGF PROCEDURE

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

ROP with anti-VEGF treatment (Group 3)

laser photocoagulation PROCEDURE

The treatment for ROP was either primary laser photocoagulation.

ROP with laser photocoagulation treatment (Group 4)

Eligibility Criteria

• Age: 1 Day - 1 Week
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Department of Ophthalmology, Chang Gung Memorial Hospital.

Taoyuan District, Linkou, 33305, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples will be collected within 1-week-of-age and then every 2 weeks (± 3 days) until PMA 40 weeks or until infant is discharged from our hospital. Samples are collected from diapers and immediately stored briefly at 4°C, and frozen at -80°C until analyzed. The microbiome profiling will be processed either by 16S rRNA sequencingor shotgun metagenomic sequencing.

MeSH Terms

Conditions

Retinopathy of Prematurity

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Wu WeiChi, M.D., PhD.

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 3, 2021
• Study Start: August 15, 2020
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

TW (1)