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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Iron Supplement.
- Who it may be relevant to
- Registry conditions: Premature Birth. Basic parameters: 14 Days — 14 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Iron Supplement
The interventional group will receive 2-3mg/kg/day of iron supplementation 4 times per week and the sham comparator will receive 2-3mg/kg/day of iron supplementation 7 times per week
Primary outcome measures
- Anemia at 6 months [Time frame: 6 months]
Secondary outcome measures (12)
- Anemia [Time frame: at 2weeks, 1 month, 2-3 months]
- Anemia [Time frame: at 2weeks, 1 month, 2-3 months]
- Ferritin [Time frame: at 2 weeks, 1 month, 2-3 months and 6 months]
- Ret-Hb level [Time frame: at 2 weeks, 1 month, 2-3 months and 6 months]
- Transfusion [Time frame: at 1 month, 2-3 months and 6 months]
- Therapeutic level [Time frame: at 1 month, 2-3 months and 6 months]
- Evaluation of abdominal inflammation [Time frame: at 2 weeks and 2-3 months]
- Evaluation of abdominal inflammation [Time frame: at 2 weeks and 2-3 months]
- Evaluation of intestinal microbiota [Time frame: at 2-3 months]
- Comorbidities [Time frame: at 6 months]
- Comorbidities [Time frame: at 6 months]
- Comorbidities [Time frame: at 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Switzerland · 2 centers
- HUG — Geneva
- CHUV — Lausanne
Identifiers
NCT: NCT06624709 · 2021-02374