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NCT04691843 · ClinicalTrials.gov registry record · Phase 3
Iron Supplementation and Neurodevelopmental Outcome in ELGANs
A Phase 3 study, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
- Completed
- Registry status
- Phase 3
- Development phase
- 51
- Enrollment target
NCT04691843 is a Phase 3 study that has completed, run by Ann & Robert H Lurie Children's Hospital of Chicago. The registered enrollment target is 51 participants.
The verdict
NCT04691843, a Phase 3 study, has completed, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 51 participants
- Enrollment target
Study 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.
Interventions
- DRUG Iron Sulfate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2021-02-01 |
| Est. Completion | 2024-08-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04691843
The ClinicalTrials.gov registry entry for NCT04691843 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ann & Robert H Lurie Children's Hospital of Chicago, which has 159 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Iron Sulfate is the first listed.
NCT04691843 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04691843 about?
NCT04691843 is a clinical study titled "Iron Supplementation and Neurodevelopmental Outcome in ELGANs". 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 u...
What is the current status of trial NCT04691843?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 51 participants. The study started on 2021-02-01. Estimated completion is 2024-08-31.
What interventions are being tested in trial NCT04691843?
The interventions under investigation include: Iron Sulfate (DRUG).
Who is sponsoring clinical trial NCT04691843?
This trial is sponsored by Ann & Robert H Lurie Children's Hospital of Chicago, which has 159 total clinical trials registered on ClinicalTrials.gov.
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