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 (BienFER)

Riccardo Pfister

Status: Enrolling

Conditions: Premature Birth

Treatments: Drug: Iron Supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT06624709

2021-02374

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 14 to 14 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups

Alternate (4 times/week) iron supplementation

Active Comparator group

Description:

This arm will receive 2-3mg/kg/d of maltofer 4 times a day

Treatment:

Drug: Iron Supplement

Daily iron substitution

Sham Comparator group

Description:

This arm will receive 2-3mg/kg/d of maltofer 7 times per week.

Treatment:

Drug: Iron Supplement