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

Sponsor
Riccardo Pfister
Study ID
NCT06624709
Status
Recruiting
Apply to this trial

Conditions

  • Premature Birth

Eligibility Criteria

Sex
ALL
Age
14 Days - 14 Days
Healthy Volunteers
Accepted

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

Study Details

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.

Key Dates

First listed
Oct 3, 2024
Start date
Nov 2, 2024
Status verified
Oct 2024
Primary completion
Sep 16, 2026
Completion
May 31, 2027

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Alternate (4 times/week) iron supplementation
    This arm will receive 2-3mg/kg/d of maltofer 4 times a day
  • Sham Comparator: Daily iron substitution
    This arm will receive 2-3mg/kg/d of maltofer 7 times per week.

Primary Outcome Measure

Anemia at 6 months [ Time Frame: 6 months ]

Central Contacts

Related Studies