Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2025-12-24 @ 10:38 PM
NCT ID:
NCT00642135
Eligibility Criteria:
Inclusion Criteria:
* Premature newborns, neonates and infants of less 18 months-old indoor in the neonatology clinical department of Robert Debre Hospital with cardiologic monitoring
* Presenting a risk of retinopathy of prematurity or fundus anomaly (chorioretinal and/or disk anomalies).
* Needing a bilateral fundus
* Parents, tutor or legal representing of the patient had been informed of objectives of the study and had given their written consent.
* Covered by French social security or CMU
Exclusion Criteria:
* Neonates of less 1000g at inclusion
* Premature newborn of less 30 weeks of gestational age at inclusion
* Contra-indication to one of the evaluated drugs
* Any treatment that could provoke a dangerous drug interaction for the patient if associated with one of the drug of the study
* Anatomical predisposition to glaucoma, hypertension or any other contra-indication noted by the physician
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Months
Study:
NCT00642135
Study Brief:
Protocol Section:
NCT00642135