NCT06624709 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
| NCT ID | NCT06624709 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Riccardo Pfister |
| Condition | Premature Birth |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2024-11-02 |
| Primary Completion | 2026-09-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2024-11-02 with a primary completion date of 2026-09-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
BienFer is a double-blinded randomized controlled trial about iron substitution and abdominal pain. Premature babies and low birth weight babies have lower iron stores than term newborns and are therefore at greater risk of iron deficiency and anemia. Iron deficiency could have consequences for cerebral development. Ferric substitution reduces the risk of iron deficiency and anemia. It is common to replace premature babies with iron substitution between 2 weeks and 6 months of life. In practice, the medical staff notice that newborn with iron substitution have abdominal pain and constipation. A study in the adult population shows that alternate iron supplementation versus daily supplementation improved iron absorption, with no difference in hemoglobin level and decrease abdominal pain. Studies in children shows that intermittent iron supplementation do not change hemoglobin and ferritin level and improve adherence. There is no data comparing daily versus alternate supplementation in premature babies. The aim of the study is to evaluate if alternate (4 times/week) iron supplementation is equivalent to daily iron substitution for hemoglobin values in premature babies between 28 0/7 weeks amenorrhea (WA) and 34 6/7 WA, and if it reduces abdominal discomfort and inflammation, and if it improves compliance.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06624709 clinical trial?
This trial is open to participants of all sexes, aged 14 Days or older, up to 14 Days, studying Premature Birth. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06624709 currently recruiting?
Yes, NCT06624709 is actively recruiting participants. Contact the research team at celine.ferraz@hcuge.ch for enrollment information.
Where is the NCT06624709 trial being conducted?
This trial is being conducted at Geneva, Switzerland, Lausanne, Switzerland.
Who is sponsoring the NCT06624709 clinical trial?
NCT06624709 is sponsored by Riccardo Pfister. The trial plans to enroll 160 participants.