Status:
COMPLETED
Iron Supplementation and Neurodevelopmental Outcome in ELGANs
Lead Sponsor:
Ann & Robert H Lurie Children's Hospital of Chicago
Conditions:
Iron-deficiency
Eligibility:
All Genders
7-4 years
Phase:
PHASE3
Brief 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 maturatio...
Detailed Description
This is a prospective, randomized, unblinded, controlled study of early, high-dose iron for neuroprotection in extremely preterm infants born between 24 0/7 weeks and 30 6/7 weeks gestation. This stud...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2024
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT04691843
Start Date
February 1 2021
End Date
August 31 2024
Last Update
November 12 2024
Active Locations (1)
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1
Prentice Women's Hospital
Chicago, Illinois, United States, 60611