Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06624709

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 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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

14 day–14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HUG, Geneva, Canton of Geneva, Switzerland

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Anemia at 6 months

    Time frame: 6 months

    Hemoglobin level

Secondary outcomes

  1. Anemia

    Time frame: at 2weeks, 1 month, 2-3 months

    Hemoglobin

  2. Anemia

    Time frame: at 2weeks, 1 month, 2-3 months

    Hematocrit level

  3. Ferritin

    Time frame: at 2 weeks, 1 month, 2-3 months and 6 months

    Ferritin

  4. Ret-Hb level

    Time frame: at 2 weeks, 1 month, 2-3 months and 6 months

    Ret-Hb level

  5. Transfusion

    Time frame: at 1 month, 2-3 months and 6 months

    Number of patients needed a transfusion

  6. Therapeutic level

    Time frame: at 1 month, 2-3 months and 6 months

    Number of patients needed to increase the iron substitution to a therapeutic level

  7. Evaluation of abdominal inflammation

    Time frame: at 2 weeks and 2-3 months

    Calprotectin level

  8. Evaluation of abdominal inflammation

    Time frame: at 2 weeks and 2-3 months

    Hepcidin level

  9. Evaluation of intestinal microbiota

    Time frame: at 2-3 months

    Fecal sequencing

  10. Comorbidities

    Time frame: at 6 months

    Number of retinopathy of prematurity (ROP)

  11. Comorbidities

    Time frame: at 6 months

    Number of periventricular leukomalacia (PVL)

  12. Comorbidities

    Time frame: at 6 months

    Number of sepsis

  13. Comorbidities

    Time frame: at 6 months

    Number of intraventricular hemorrhage (IVH)

  14. Comorbidities

    Time frame: at 6 months

    Number of bronchopulmonary dysplasia (BPD)

  15. Comorbidities

    Time frame: at 6 months

    Number of necrotizing enterocolitis (NEC)

  16. Evaluation of weight gain

    Time frame: at 2 weeks, 1 month, 2-3 months and 6 months

    Tracking weight in Kilograms

  17. Evaluation of height gain

    Time frame: at 2 weeks, 1 month, 2-3 months and 6 months

    Tracking height in Centimeters

  18. Evaluation of the growth's parameter

    Time frame: at 2 weeks, 1 month, 2-3 months and 6 months

    Tracking head circumference in Centimeters

  19. Evaluation of abdominal discomfort

    Time frame: 3 times per week during hospitalization then 1 time per 2 weeks until 6 months

    Edin scale (0 (better outcome, no pain)-15 (worse outcome, pain))

  20. Evaluation of abdominal discomfort

    Time frame: 3 times per day during hospitalization then 1 time per 2 weeks until 6 months

    Classify stools with Bristol scale (1 (severe constipation) -7 (severe diarrhea))

Study contacts

Contact information is provided by the study sponsor or research team.

Céline Ferraz

CONTACT

[email protected]

+41 79 553 84 54

Riccardo E Pfister, MD, PHD

CONTACT

[email protected]

+41 79 553 44 38

Sponsors and collaborators

Lead sponsor

Riccardo Pfister

Other

Registry information

Acronym: BienFER

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 3, 2024
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.