Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Premature Birth
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 160
Sex: ALL
Minimum age (years): 14
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Anemia at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Anemia
timeFrame: at 2weeks, 1 month, 2-3 months
measure: Anemia
timeFrame: at 2weeks, 1 month, 2-3 months
measure: Ferritin
timeFrame: at 2 weeks, 1 month, 2-3 months and 6 months
measure: Ret-Hb level
timeFrame: at 2 weeks, 1 month, 2-3 months and 6 months
measure: Transfusion
timeFrame: at 1 month, 2-3 months and 6 months
measure: Therapeutic level
timeFrame: at 1 month, 2-3 months and 6 months
measure: Evaluation of abdominal inflammation
timeFrame: at 2 weeks and 2-3 months
measure: Evaluation of abdominal inflammation
timeFrame: at 2 weeks and 2-3 months
measure: Evaluation of intestinal microbiota
timeFrame: at 2-3 months
measure: Comorbidities
timeFrame: at 6 months
measure: Comorbidities
timeFrame: at 6 months
measure: Comorbidities
timeFrame: at 6 months
measure: Comorbidities
timeFrame: at 6 months
measure: Comorbidities
timeFrame: at 6 months
measure: Comorbidities
timeFrame: at 6 months
measure: Evaluation of weight gain
timeFrame: at 2 weeks, 1 month, 2-3 months and 6 months
measure: Evaluation of height gain
timeFrame: at 2 weeks, 1 month, 2-3 months and 6 months
measure: Evaluation of the growth's parameter
timeFrame: at 2 weeks, 1 month, 2-3 months and 6 months
measure: Evaluation of abdominal discomfort
timeFrame: 3 times per week during hospitalization then 1 time per 2 weeks until 6 months
measure: Evaluation of abdominal discomfort
timeFrame: 3 times per day during hospitalization then 1 time per 2 weeks until 6 months
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: HUG
state: GE
city: Lausanne
country: Switzerland
facility: CHUV
state: VD
Study officials:
References: