Iron Sulfate for Iron Deficiency Anemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Iron Deficiency AnemiaIron Sulfate - Drug
Eligibility
7 - 4
All Sexes
What conditions do you have?
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Study Summary

This trial looks at whether giving iron supplements to premature babies earlier can help improve their neurological development.

Eligible Conditions
  • Iron Deficiency Anemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 22-26 months corrected age

22-26 months corrected age
Neurodevelopmental outcome in participants
Week 40
Adrenal gland hypofunction
Iron insufficiency as assessed by hemoglobin level (g/dL)
Iron insufficiency as assessed by reticulocyte count (%)
Iron insufficiency as assessed by reticulocyte hemoglobin equivalent (Ret-He, pg)
Week 16
Assess whether measurement of ferritin (ng/mL) or hemoglobin (g/dL) is superior in guiding intervention of iron-insufficiency
Assess whether measurement of ferritin (ng/mL) or reticulocyte count (%) is superior in guiding intervention of iron-insufficiency

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Standard iron dose
1 of 2
Early, high-dose iron
1 of 2

Active Control

Experimental Treatment

90 Total Participants · 2 Treatment Groups

Primary Treatment: Iron Sulfate · No Placebo Group · N/A

Early, high-dose iron
Drug
Experimental Group · 1 Intervention: Iron Sulfate · Intervention Types: Drug
Standard iron dose
Drug
ActiveComparator Group · 1 Intervention: Iron Sulfate · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 22-26 months corrected age

Who is running the clinical trial?

Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor
232 Previous Clinical Trials
5,178,168 Total Patients Enrolled
Janine Y Khan, MD, MBAPrincipal InvestigatorAnn & Robert H Lurie Children's Hospital of Chicago

Eligibility Criteria

Age 7 - 4 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Infants who are more than one week old and can tolerate at least 60ml/kg/day of feed through their stomachs are considered eligible for enrollment in the study.
The study included NICU inpatients between 24-0/7 and 30-6/7 weeks of gestation.