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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Biological, Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5 months
Maximum Age: 7 months
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Ophtalmology department _ Necker Enfants Malades Hospital
ACTIVE_NOT_RECRUITING
Paris
Pediatrics and neonatal intensive care department - Cochin hospital - Port Royal Maternity
RECRUITING
Paris
Pediatrics and noenatal intensive care department - Necker-Enfants Malades Hospital
RECRUITING
Paris
Contact Information
Primary
Alejandra DARUICH, MD, PhD
alejandra.daruich-matet@aphp.fr
+33-(0)1-44-38-19-69
Backup
Prissile BAKOUBOULA, PhD
prissile.bakouboula@aphp.fr
+33-(0)1-71-19-64-94
Time Frame
Start Date: 2022-04-28
Estimated Completion Date: 2025-09
Participants
Target number of participants: 175
Treatments
Preterm infants
infants born at \<31 week's post-menstrual age (PMA) or ≤1250g of birth weight
Related Therapeutic Areas
Sponsors
Collaborators: Fondation Université de Paris, Fondation VISIO
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov