Improve Screening Criteria for Retinopathy of Prematurity in Two French Center

NCT05152862 | Completed

• 1 other identifier: 2021/0053
• Study Type: observational
• Target: 886
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to assess whether a delay of the first examination can be safely considered in French population. Secondary objectives are to describe retinopathy of prematurity (ROP) in a population of premature from two French tertiary NICU and to identify co-morbidities associated with the development of severe ROP.

Conditions

Retinopathy of Prematurity

Keywords

birth weight; gestational age; premature; retina; screening

Outcome Measures

Primary Outcomes (1)

• Number of infants with type 1 or 2 ROP found at routine screening.

  Number

  Day 0

Secondary Outcomes (3)

• Time from first retinal examination to treatment of ROP

  Day 0

• Postnatal age / SAC at first by gestational age

  Day 0

• Time from first retinal examination to diagnostic of severe ROP

  Day 0

Interventions

Laser PROCEDURE

Retinal laser photocoagulation

Anti VEGF PROCEDURE

Anti-VEGF intravitreous injection

Eligibility Criteria

• Age: 0 Years - 31 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Cohort will be selected among all premature born between January 2016 and November 2020 and hospitalized in Centre Hospitalier Sud Francilien (Corbeil Essonnes 91) and Hopital Robert Debré (Paris 75).

You may qualify if:

• Infant with gestational age \< 31 weeks and/or birth weight \< 1250 g
• With at least one retinal examination
• holders of the parental rights informed and not objecting to the study

You may not qualify if:

• infants died before 28 days PNA
• infants with hydrocephaly.
• infants with significant congenital malformations or genetic abnormalities.

Sponsors & Collaborators

• Centre Hospitalier Sud Francilien: lead

Study Sites (1)

LEROUX Pauline

Corbeil-Essonnes, France, 91106, France

Location

MeSH Terms

Conditions

Retinopathy of Prematurity; Birth Weight; Premature Birth

Interventions

Lasers

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Pauline LEROUX, MD

  Centre Hospitalier Sud Francilien

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 10, 2021
• Study Start: March 21, 2022
• Primary Completion: June 16, 2022
• Study Completion: June 16, 2022
• Last Updated: November 26, 2024

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)