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Iron and Retinopathy of Prematurity (ROP)

NCT05133999 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 175

Last updated 2025-11-20

No results posted yet for this study

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.

Conditions

  • Retinopathy of Prematurity

Interventions

BIOLOGICAL

Plasma determination of iron, transferrin and ferritin

Iron, transferrin and ferritin levels in plasma

OTHER

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

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

Sponsors & Collaborators

  • Fondation VISIO

    collaborator UNKNOWN

  • Fondation Université de Paris

    collaborator UNKNOWN

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Alejandra DARUICH, MD, PhD · Assistance Publique - Hôpitaux de Paris

  • Elsa KERMOVANT, MD, PhD · Assistance Publique - Hôpitaux de Paris

Eligibility

Min Age
24 Weeks
Max Age
31 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-28
Primary Completion
2025-08-18
Completion
2025-08-18

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05133999 on ClinicalTrials.gov