Iron supplementation for very low birth weight infants
Enteral Iron Supplementation and Intestinal Health in Preterm Infants
This study is testing whether giving very low birth weight infants different amounts of iron can improve their gut health and reduce inflammation.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 183 (estimated) |
| Ages | 1 Day to 6 Months |
| Sex | All |
| Sponsor | University of South Florida Academic / other |
| Locations | 1 site (Tampa, Florida) |
| Trial ID | NCT04497012 on ClinicalTrials.gov |
What this trial studies
This randomized double-blinded study investigates the effects of enteral iron supplementation on intestinal health in very low birth weight infants. Participants will be assigned to receive either a low dose (2 mg/kg/day) or a high dose (6 mg/kg/day) of iron, with the primary outcomes focusing on microbiome health, inflammation levels, and intestinal barrier function. The study will recruit infants from a single academic NICU, and various biological samples will be collected to assess the impact of iron supplementation over time.
Who should consider this trial
Good fit: Ideal candidates are infants weighing less than 1500 grams at birth who are expected to survive beyond two weeks and have not yet started oral iron supplementation.
Not a fit: Patients with congenital intestinal defects or those who have a history of intestinal infections or perforations will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve intestinal health and overall outcomes for very low birth weight infants suffering from anemia.
How similar studies have performed: Other studies have shown promising results with iron supplementation in similar populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \<1500 g at birth, expected to live beyond 2 weeks, not yet started on oral iron supplementation (OIS), with mother at least 18 years of age, and parental consent. Exclusion Criteria: * congenital intestinal defects, history of intestinal infection or perforation before OIS. Infants who require epogen for religious reason to prevent them from getting blood transfusions will be excluded from the study.
Where this trial is running
Tampa, Florida
- Tampa General Hospital — Tampa, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Marcia Kneusel
- Email: mkneusel@usf.edu
- Phone: 813-844-3395
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.