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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 14 days
Maximum Age: 14 days
Healthy Volunteers: t
View:

• Premature babies between 28 0/7WA and 34 6/7 WA

• Parental consent, postnatal

• Age of 2 weeks

Locations
Other Locations
Switzerland
HUG
RECRUITING
Geneva
CHUV
RECRUITING
Lausanne
Contact Information
Primary
Céline Ferraz
celine.ferraz@hcuge.ch
+41 79 553 84 54
Backup
Riccardo E Pfister, MD, PHD
riccardo.pfister@hug.ch
+41 79 553 44 38
Time Frame
Start Date: 2024-11-02
Estimated Completion Date: 2027-05
Participants
Target number of participants: 160
Treatments
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.
Sponsors
Leads: Riccardo Pfister

This content was sourced from clinicaltrials.gov