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NCT06624709: BienFER
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
NA trial testing Iron Supplement in Premature Birth in 160 participants. Currently enrolling.
16 September 2026
Quick facts
| Lead sponsor | Riccardo Pfister |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 160 |
| Start date | 2 November 2024 |
| Primary completion | 16 September 2026 |
| Estimated completion | 1 May 2027 |
| Sites | 2 locations across Switzerland |
Drugs / interventions tested
- Iron Supplement — full drug profile →
Conditions studied
- Premature Birth — all drugs for Premature Birth →
Sponsor
Riccardo Pfister
Who can join
Adults 14 Days to 14 Days, any sex, with Premature Birth. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Anemia at 6 months
Time frame: 6 months
Hemoglobin level
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06624709
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Iron Supplement
Trials testing the same drug.
- NCT07095244 — Pediatric Outcomes and Recovery With Peri-Operative Iron Supplement Evaluation · NA · not yet recruiting
- NCT04014855 — Lactoferrin Versus Iron Supplement in Irondeficiency Anemia and Weight Loss in Obese Children · Phase 4 · completed
- NCT03382275 — EXPLorative Data Collection for Patient chAracterIzation, treatmeNt Pathways and Outcomes of IRON Preparations · completed
- NCT03542825 — Oral Lactoferrin Versus Iron Supplementation During Pregnancy · Phase 4 · completed
- NCT03112187 — FLIPS: Ferfer Liposomal Iron Performance Study · Phase 4 · completed
Other recruiting trials for Premature Birth
Currently open trials in the same condition.
- NCT07490912 — Neonatal Data and Biobank to Study Factors Influencing Development in Preterm Infants Born at <32 Weeks' Gestation and/o · recruiting
- NCT07183462 — Azithromycin and Ampicillin for Late PPROM · Phase 4 · recruiting
- NCT07306793 — The Effect of PIOMI and Chronobiological Nutrition on Readiness for Feeding, Full Transition to Oral Feeding and Body We · NA · recruiting
- NCT06554522 — Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa · Phase 4 · recruiting
- NCT06340971 — Air Pollution and Pregnancy · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06624709 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Riccardo Pfister
- Last refreshed: 23 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06624709.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing