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Study identifier: NCT06624709 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Premature Birth  ·  Sponsor: Riccardo Pfister

PhaseNA
Planned participants160
Who can joinAll sexes, 14 Days to 14 Days
Healthy volunteersYes

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Céline Ferraz  ·  +41 79 553 84 54  ·  celine.ferraz@hcuge.ch

Riccardo E Pfister, MD, PHD  ·  +41 79 553 44 38  ·  riccardo.pfister@hug.ch

Always discuss trial participation with your own doctor first.

Locations (2)

HUGGeneva, Canton of Geneva, SwitzerlandRecruiting
CHUVLausanne, Canton of Vaud, SwitzerlandRecruiting

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Source record: clinicaltrials.gov/study/NCT06624709