Iron Supplementation and Neurodevelopmental Outcome in ELGANs

• Status: Recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Criteria

Inclusion Criteria:

• NICU inpatients between 24-0/7 and 30-6/7 weeks of gestation

• Infants older than one week of age and tolerating at least 60ml/kg/day of enteral feeds.

• Parental permission obtained prior to start of study

Exclusion Criteria:

• In extremis during consent window (as judged by primary attending provider)

• Known or suspected genetic disorder

• Unable to return for follow-up evaluation at 2 years of age