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

Not Applicable

Recruiting

• Conditions: Premature Birth
• Interventions: Drug: Iron Supplement

• Registration Number: NCT06624709
• Lead Sponsor: Riccardo Pfister

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-14
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-02
• Study First Posted: 2024-10-03
• Study Start: 2024-11-02
• Last Update Submitted: 2025-05-23
• Last Update Posted: 2025-05-25
• Primary Completion: 2026-09-16
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Daily iron substitution	Iron Supplement	This arm will receive 2-3mg/kg/d of maltofer 7 times per week.
Alternate (4 times/week) iron supplementation	Iron Supplement	This arm will receive 2-3mg/kg/d of maltofer 4 times a day

Primary Outcome Measures

Name	Time	Method
Anemia at 6 months	6 months	Hemoglobin level

Secondary Outcome Measures

Name	Time	Method
Anemia	at 2weeks, 1 month, 2-3 months	Hematocrit level
Ferritin	at 2 weeks, 1 month, 2-3 months and 6 months	Ferritin
Evaluation of abdominal inflammation	at 2 weeks and 2-3 months	Hepcidin level
Evaluation of intestinal microbiota	at 2-3 months	Fecal sequencing
Ret-Hb level	at 2 weeks, 1 month, 2-3 months and 6 months	Ret-Hb level
Transfusion	at 1 month, 2-3 months and 6 months	Number of patients needed a transfusion
Therapeutic level	at 1 month, 2-3 months and 6 months	Number of patients needed to increase the iron substitution to a therapeutic level
Comorbidities	at 6 months	Number of necrotizing enterocolitis (NEC)
Evaluation of weight gain	at 2 weeks, 1 month, 2-3 months and 6 months	Tracking weight in Kilograms
Evaluation of height gain	at 2 weeks, 1 month, 2-3 months and 6 months	Tracking height in Centimeters
Evaluation of the growth's parameter	at 2 weeks, 1 month, 2-3 months and 6 months	Tracking head circumference in Centimeters
Evaluation of abdominal discomfort	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))

Trial Locations

Locations (2)

HUG; 🇨🇭 Geneva, GE, Switzerland

CHUV; 🇨🇭 Lausanne, VD, Switzerland