Iron Supplementation and Neurodevelopmental Outcome in ELGANs
Status:
Recruiting
Trial end date:
2024-09-01
Target enrollment:
Participant gender:
Summary
This study explores the relationship between iron deficiency and neurological outcome of
extremely premature infants. Premature birth occurs during a critical period of brain
development and maturation, and before adequate transfer of iron across the placenta.
Nutrition has a significant impact on ultimate outcome of survivors of prematurity. One of
the biomarkers of nutrition in the premature infant is iron, and iron supplementation is
essential for growth and brain development at low gestational age. As a result, the Committee
on Nutrition of the American Academy of Pediatrics (AAP) recommends daily oral iron
supplementation, of at least 2-4 mg/kg/day from 2 weeks of age, to prevent iron deficiency in
extremely premature infants. Nevertheless, studies have shown that even with this regular
care dose of iron, started from 2 weeks of age, a significant number of premature infants
will still develop iron-deficiency. Our hypothesis states that starting high dose iron
supplementation early will improve neurological development and outcome in extremely
premature infants (those born at less than 28 weeks gestational age). This study will provide
data showing whether individualized iron supplementation using higher doses of iron, started
earlier (after the first week of life) when guided by periodic screening of their body's iron
status with ferritin levels, will mitigate iron deficiency and promote improved
neurodevelopmental outcome in this vulnerable infant population.
Phase:
N/A
Details
Lead Sponsor:
Ann & Robert H Lurie Children's Hospital of Chicago