Comparing iron supplementation methods in premature babies
The Benefit in Terms of Improvement in Haemoglobin Level at 6 Months in Premature Babies Receiving Alternate Iron Substitution 4 Times a Week Compared to a Daily Substitution
This study is testing if giving iron to premature babies four times a week instead of every day can help their blood levels while causing less tummy pain and constipation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 14 Days to 14 Days |
| Sex | All |
| Sponsor | University Hospital, Geneva Academic / other |
| Locations | 2 sites (Geneva, Canton of Geneva and 1 other locations) |
| Trial ID | NCT06624709 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of alternate iron supplementation four times a week versus daily iron supplementation in premature infants aged 2 weeks to 6 months. The study aims to determine if the alternate method can improve hemoglobin levels while reducing abdominal pain and constipation, which are common side effects of iron supplementation. By utilizing a double-blinded randomized controlled design, the trial seeks to provide robust data on the efficacy and tolerability of these two approaches to iron supplementation in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are premature babies born between 28 and 34 weeks of gestation who are at least 2 weeks old.
Not a fit: Patients with severe anemia, significant congenital disorders, or specific gastrointestinal complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved iron supplementation practices that enhance the health and development of premature infants.
How similar studies have performed: Previous studies have shown that alternate iron supplementation can improve adherence and reduce side effects, but this specific comparison in premature infants is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Premature babies between 28 0/7WA and 34 6/7 WA * Parental consent, postnatal * Age of 2 weeks Exclusion Criteria: * anemia \< 80g/l at 2 weeks of age * Intraventricular Hemorrhage stage III and IV * Necrotizing Enterocolitis * Enteral feeding less than 100ml/kg/j after 2 weeks of life * Congenital disorder
Where this trial is running
Geneva, Canton of Geneva and 1 other locations
- Hug — Geneva, Canton of Geneva, Switzerland (Recruiting)
- Chuv — Lausanne, Canton of Vaud, Switzerland (Recruiting)
Study contacts
- Study coordinator: Céline Ferraz
- Email: celine.ferraz@hcuge.ch
- Phone: +41 79 553 84 54
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.