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

NCT06624709 | Recruiting DMC

• 1 other identifier: 2021-02374
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

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.

Conditions

Premature Birth

Outcome Measures

Primary Outcomes (1)

• Anemia at 6 months

  Hemoglobin level

  6 months

Secondary Outcomes (20)

• Anemia

  at 2weeks, 1 month, 2-3 months

• Anemia

  at 2weeks, 1 month, 2-3 months

• Ferritin

  at 2 weeks, 1 month, 2-3 months and 6 months

• Ret-Hb level

  at 2 weeks, 1 month, 2-3 months and 6 months

• Transfusion

  at 1 month, 2-3 months and 6 months

Study Arms (2)

Alternate (4 times/week) iron supplementation

ACTIVE COMPARATOR

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

Drug: Iron Supplement

Daily iron substitution

SHAM COMPARATOR

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

Drug: Iron Supplement

Interventions

Iron Supplement DRUG

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

Alternate (4 times/week) iron supplementation; Daily iron substitution

Eligibility Criteria

• Age: 14 Days - 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Premature babies between 28 0/7WA and 34 6/7 WA
• Parental consent, postnatal
• Age of 2 weeks

You may not qualify if:

• 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

Sponsors & Collaborators

• Riccardo Pfister: lead

Study Sites (2)

HUG

Geneva, Canton of Geneva, 1211, Switzerland

RECRUITING

CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

MeSH Terms

Conditions

Premature Birth

Interventions

Iron-Dextran Complex

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates

Central Study Contacts

Céline Ferraz

CONTACT

+41 79 553 84 54; celine.ferraz@hcuge.ch

Riccardo E Pfister, MD, PHD

CONTACT

+41 79 553 44 38; riccardo.pfister@hug.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of neonatology department, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: September 14, 2024
• First Posted: October 3, 2024
• Study Start: November 2, 2024
• Primary Completion (Estimated): September 16, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 25, 2025

Record last verified: 2024-10

Locations

CH (2)