Investigating the role of iron levels in preterm infants with Retinopathy of Prematurity
Iron, Transferrin and Retinopathy of Prematurity (ROP): Towards New Pathophysiological Mechanisms.
This study is trying to see if high iron levels in the blood can affect the development and severity of vision problems in preterm babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 175 (estimated) |
| Ages | 24 Weeks to 31 Weeks |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 3 sites (Paris and 2 other locations) |
| Trial ID | NCT05133999 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess whether increased transferrin saturation in plasma, indicative of iron overload or low transferrin, is an independent risk factor for the development and severity of Retinopathy of Prematurity (ROP) in preterm infants. Infants born at less than 31 weeks of gestation or weighing 1250 grams or less will have their plasma iron parameters measured during the first month of life. The study will screen for ROP as per current recommendations and analyze the relationship between plasma iron levels and ROP outcomes. The findings could clarify the controversial link between iron overload from blood transfusions and ROP.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants born at less than 31 weeks of gestation or weighing 1250 grams or less.
Not a fit: Patients with congenital malformations or life-threatening conditions that are not expected to survive more than a few days may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved screening and management strategies for preterm infants at risk of ROP.
How similar studies have performed: Previous studies on this topic have shown mixed results, indicating that this area of research is still under investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All infants born at \<31 week's post-menstrual age (PMA) or ≤1250g of birthweight * Admitted at two neonatology departments (level III) from birth * With non-opposition consent of two parents Exclusion Criteria: * Congenital malformation * Life-threatening condition (not expected to survive more than a few days) * Absence of health care protection.
Where this trial is running
Paris and 2 other locations
- Pediatrics and neonatal intensive care department - Cochin hospital - Port Royal Maternity — Paris, France (Recruiting)
- Ophtalmology department _ Necker Enfants Malades Hospital — Paris, France (Active_not_recruiting)
- Pediatrics and noenatal intensive care department - Necker-Enfants Malades Hospital — Paris, France (Recruiting)
Study contacts
- Principal investigator: Alejandra DARUICH, MD, PhD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Alejandra DARUICH, MD, PhD
- Email: alejandra.daruich-matet@aphp.fr
- Phone: +33-(0)1-44-38-19-69
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.