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
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Riccardo Pfister
- Enrollment
- 160
- Locations
- 2
- Primary Endpoint
- Anemia at 6 months
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Investigator)
Eligibility Criteria
- Ages
- 14 Days to 14 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Alternate (4 times/week) iron supplementation
This arm will receive 2-3mg/kg/d of maltofer 4 times a day
Intervention: Iron Supplement (Drug)
Daily iron substitution
This arm will receive 2-3mg/kg/d of maltofer 7 times per week.
Intervention: Iron Supplement (Drug)
Outcomes
Primary Outcomes
Anemia at 6 months
Time Frame: 6 months
Hemoglobin level
Secondary Outcomes
- Anemia(at 2weeks, 1 month, 2-3 months)
- Ferritin(at 2 weeks, 1 month, 2-3 months and 6 months)
- Evaluation of abdominal inflammation(at 2 weeks and 2-3 months)
- Evaluation of intestinal microbiota(at 2-3 months)
- Ret-Hb level(at 2 weeks, 1 month, 2-3 months and 6 months)
- Transfusion(at 1 month, 2-3 months and 6 months)
- Therapeutic level(at 1 month, 2-3 months and 6 months)
- Comorbidities(at 6 months)
- Evaluation of weight gain(at 2 weeks, 1 month, 2-3 months and 6 months)
- Evaluation of height gain(at 2 weeks, 1 month, 2-3 months and 6 months)
- Evaluation of the growth's parameter(at 2 weeks, 1 month, 2-3 months and 6 months)
- Evaluation of abdominal discomfort(3 times per day during hospitalization then 1 time per 2 weeks until 6 months)
Investigators
Riccardo Pfister
Head of neonatology department, Principal Investigator, Clinical Professor
University Hospital, Geneva