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Iron and Retinopathy of Prematurity (ROP) - Trial NCT05133999

Access comprehensive clinical trial information for NCT05133999 through Pure Global AI's free database. This phase not specified trial is sponsored by Assistance Publique - Hรดpitaux de Paris and is currently Recruiting. The study focuses on Retinopathy of Prematurity. Target enrollment is 175 participants.

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NCT05133999
Recruiting
biological
Trial Details
ClinicalTrials.gov โ€ข NCT05133999
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Iron and Retinopathy of Prematurity (ROP)
Iron, Transferrin and Retinopathy of Prematurity (ROP): Towards New Pathophysiological Mechanisms.

Study Focus

Plasma determination of iron, transferrin and ferritin

Observational

biological

Sponsor & Location

Assistance Publique - Hรดpitaux de Paris

Paris,Paris,Paris, France

Timeline & Enrollment

N/A

Apr 28, 2022

Sep 01, 2024

175 participants

Primary Outcome

ROP screening,Levels of transferrin saturation in plasma at 1 week of life

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 โ‰ค1250g 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.

ICD-10 Classifications

Retinopathy of prematurity
Other proliferative retinopathy
Background retinopathy and retinal vascular changes
Diabetic retinopathy
Retinal disorder, unspecified

Data Source

ClinicalTrials.gov

NCT05133999

Non-Device Trial