Genetic biomarkers for retinopathy of prematurity

Not Applicable

Completed

• Conditions: Retinopathy of prematurity; Eye Diseases

• Registration Number: ISRCTN16889608
• Lead Sponsor: Institute of Environmental Health (ISAMB) of the Lisbon School of Medicine

Brief Summary

2023 Results article in https://doi.org/10.1007/s00417-023-06072-7 (added 09/06/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-22
• Study Completion: 2022-08-30
• Last Update Posted: 20 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

Preterm infants and their mothers, with at least one of the following newborn characteristics:
1. Born before 32 weeks of gestational age
2. Born with a birth weight of less than 1500 g

Exclusion Criteria

1. Infants:
1.1. The existence of major congenital malformations
1.2. Ophthalmological pathologies, congenital or acquired (during the first 12 weeks of life) not related to ROP with the exception of conjunctivitis, keratitis and congenital obstruction of the tear-nasal canal
2. Mothers:
2.1. Diabetes
2.2. Gestation resulting from artificial fertilization
2.3. Insufficient clinical data
3. Legal guardians:
3.1. Absence of informed consent

It should be noted that when the mother is excluded, the infant can still form part of the study, provided informed consent is given.

Study & Design

• Study Type: Observational
• Study Design: Not specified