Investigating Iron Dosing in Premature Infants
Pilot Non-inferiority Study Investigating Daily Versus Every Other Day Dosing of Oral Iron in Premature Infants.
This study tests if giving iron to premature infants every other day works just as well as daily doses to keep their iron levels healthy while causing fewer stomach issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 26 Weeks to 32 Weeks |
| Sex | All |
| Sponsor | CHRISTUS Health Academic / other |
| Locations | 1 site (San Antonio, Texas) |
| Trial ID | NCT06555315 on ClinicalTrials.gov |
What this trial studies
This trial examines the effectiveness of administering oral iron every other day compared to daily dosing in premature infants to achieve similar iron replete status by 36 weeks post-menstrual age. The study focuses on very low birth weight infants who are at high risk for iron deficiency due to their premature birth and rapid growth. By utilizing a randomized control design, the trial aims to determine if less frequent dosing can maintain iron levels while potentially reducing gastrointestinal side effects. The findings could provide insights into optimal iron supplementation strategies for this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are hospitalized premature infants born between 26 to 32 weeks of gestation who are on full enteral feeds and have started oral iron supplementation.
Not a fit: Patients with congenital anomalies, chromosomal abnormalities, or conditions affecting iron metabolism will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved iron supplementation protocols for premature infants, enhancing their health outcomes and neurodevelopment.
How similar studies have performed: Previous studies in older populations have shown that every other day iron supplementation is effective, suggesting potential for success in this novel application for premature infants.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children (Minor \< 18 years of age) * Neonates * Hospitalized * Premature infants who are on full enteral feeds and are started on oral iron * Premature infants who completed 26 0/7 to 32 6/7 weeks' gestation at birth Exclusion Criteria: • Infants with known congenital anomalies or chromosomal abnormalities (such as Trisomy 18 or Trisomy 21), conditions that affect iron metabolism (such as thalassemia or hemochromatosis), bleeding disorders or coagulopathy, and received iron parenterally prior to randomization
Where this trial is running
San Antonio, Texas
- CHRISTUS Children's — San Antonio, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Pratik K Parikh, MD — CHRISTUS Health
- Study coordinator: Rosario Ocampo
- Email: rosario.ocampo@christushealth.org
- Phone: 210-704-4996
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.