CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 175 enrolled
Drug / intervention
Plasma determination of iron, transferrin and ferritin +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05133999
NCT05133999N/ACompleted

Iron, Transferrin and Retinopathy of Prematurity (ROP): Towards New Pathophysiological Mechanisms.

Assistance Publique - Hôpitaux de Paris·observational·Posted Nov 24, 2021·Updated Nov 20, 2025

In Brief

An observational study evaluating Plasma determination of iron, transferrin and ferritin and Fundus Examination by wide field digital imaging camera (PanocamTM camera) for Retinopathy of Prematurity. Completed, enrolled 175 participants across 3 sites.

Detailed Summary

The purpose of this study is to determine whether increased transferrin saturation in plasma (that reflects iron overload and/or low transferrin) is an independent risk factor for ROP development and severity. Preterm infants born at \<31 week's post-menstrual age (PMA) or ≤1250g of birth weight will be included. Iron parameters in plasma will be measured during the first month of life. Retinopathy of prematurity (ROP) will be screened as currently recommended. The relationship between plasma iron parameters and ROP development and/or severity will be established.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesFrance

Timeline

N/ACompletedFinished
20222023202420252026
First PostedNov 24, 2021
Enrollment StartApr 28, 2022
Primary CompletionAug 18, 2025
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 4.6 years ago

Interventions

Plasma determination of iron, transferrin and ferritinbiological

Iron, transferrin and ferritin levels in plasma

Fundus Examination by wide field digital imaging camera (PanocamTM camera)other

ROP screening using wide field digital retinal imaging according to current recommendations.