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Iron Supplement

Iron Supplementation for Premature Babies' Neurodevelopment

Phase 3
Recruiting
Led By Janine Y Khan, MD, MBA
Research Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
NICU inpatients between 24-0/7 and 30-6/7 weeks of gestation
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 22-26 months corrected age
Awards & highlights

Study Summary

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

Who is the study for?
This trial is for extremely premature infants born between 24 and nearly 31 weeks of gestation, who are more than one week old and can tolerate at least 60ml/kg/day of enteral feeds. Infants with genetic disorders or those in critical condition during the consent window, as well as those unable to return for a follow-up evaluation at age two, cannot participate.Check my eligibility
What is being tested?
The study tests whether high-dose iron supplementation started early (after the first week of life) improves neurological development in these infants. It compares regular care doses with higher doses guided by periodic screening using ferritin levels to assess body iron status.See study design
What are the potential side effects?
While not explicitly stated here, common side effects of iron supplements may include stomach upset, constipation or diarrhea, nausea, and vomiting. In this vulnerable population, close monitoring will be essential.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My baby was born between 24 and 30 weeks of pregnancy and is in the NICU.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~22-26 months corrected age
This trial's timeline: 3 weeks for screening, Varies for treatment, and 22-26 months corrected age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Neurodevelopmental outcome in participants
Secondary outcome measures
Adrenal gland hypofunction
Iron insufficiency as assessed by hemoglobin level (g/dL)
Iron insufficiency as assessed by reticulocyte count (%)
+1 more
Other outcome measures
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 Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Early, high-dose ironExperimental Treatment1 Intervention
Iron supplementation will start at 3mg/kg/day when infant is on enteral feeds of 60mL/kg/day and at least one week old, then increased to 6mg/kg/day when enteral feeds are at 100mL/kg/day. Iron dosing will be adjusted to maintain ferritin level of 70-400ng/mL. At 36 weeks corrected age, iron supplementation will be adjusted to the dose routinely used for preterm infants.
Group II: Standard iron doseActive Control1 Intervention
Iron supplementation of 4mg/kg/day will start when infant is on full enteral feedings of 120-150mL/kg/day and at least two weeks old. Iron dosing will be adjusted for weight at weekly intervals to maintain dosing at 4mg/kg/day.

Find a Location

Who is running the clinical trial?

Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor
258 Previous Clinical Trials
5,189,040 Total Patients Enrolled
Janine Y Khan, MD, MBAPrincipal InvestigatorAnn & Robert H Lurie Children's Hospital of Chicago

Media Library

Iron Sulfate (Iron Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04691843 — Phase 3
Iron-Deficiency Anemia Research Study Groups: Standard iron dose, Early, high-dose iron
Iron-Deficiency Anemia Clinical Trial 2023: Iron Sulfate Highlights & Side Effects. Trial Name: NCT04691843 — Phase 3
Iron Sulfate (Iron Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04691843 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are taking part in this clinical experiment?

"Affirmative. The relevant information on clinicaltrials.gov denotes that this research trial has been enrolling patients since February 1st 2021 and is still ongoing, as per the last edit of July 28th 2021. A total of 90 individuals are needed from one medical centre for successful completion of the study."

Answered by AI

What are the primary applications of Iron Sulfate?

"Iron Sulfate is typically prescribed for folate deficiency but can be effective in the management of hypochromic anemia, breastfeeding women, and iron-deficient anemia."

Answered by AI

Is recruitment still ongoing for this clinical trial?

"Affirmative. Clinicaltrials.gov records show that this experiment is presently recruiting participants, which was initially published on February 1st 2021 and the latest update being July 28th 2021. The total amount of participants required for this trial are 90 individuals at a single medical facility."

Answered by AI

Is the elderly population being included in this clinical investigation?

"As per this clinical trial's requirements for eligibility, participants must be aged between 7 Days and 4 Weeks."

Answered by AI

What eligibility criteria must be met in order to join this medical experiment?

"Qualified patients for this medical trial should have iron-deficiency and be between the ages of seven days to four weeks old. The study is hoping to enroll up to ninety participants."

Answered by AI

What precedent has been set for the use of Iron Sulfate in research studies?

"Presently, 78 Iron Sulfate trials are in progress globally with 35 of those reaching Phase 3. Sioux Falls, South dakota is one hub for this clinical research; however, many other locations worldwide have trials involving the investigational drug."

Answered by AI

Who else is applying?

What state do they live in?
Iowa
Illinois
What site did they apply to?
Prentice Women's Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
Recent research and studies
clinicaltrials.govStudy
Iron Supplementation and Neurodevelopmental Outcome in ELGANs
Janine Yasmin Khan 2021. "Iron Supplementation and Neurodevelopmental Outcome in ELGANs". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04691843.
~8 spots leftby Sep 2024
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