Iron and Retinopathy of Prematurity (ROP)

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Nov 16, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a condition called Retinopathy of Prematurity (ROP), which affects premature infants and can lead to vision problems. The researchers want to see if the amount of iron in the blood, specifically a measure called transferrin saturation, is linked to the development and severity of ROP. They will be looking at preterm infants who are born before 31 weeks of pregnancy or weigh less than 1250 grams. The study will involve measuring certain iron levels in these infants during their first month of life and checking for signs of ROP as currently recommended.

To participate, infants must meet specific criteria, such as being born very prematurely or at a low birth weight and being cared for in a specialized neonatal unit. Parents need to provide consent for their participation. The trial is currently recruiting participants, and it aims to better understand the relationship between iron levels and ROP, which could help improve care for these vulnerable infants. If eligible, parents can expect regular screenings and blood tests for their babies during the study.

Gender

ALL

Eligibility 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.