Premature Birth
Conditions
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.
Interventions
DRUGIron Supplement
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
Sponsors
Riccardo Pfister
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
14 Days to 14 Days
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anemia at 6 months | 6 months | Hemoglobin level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of height gain | at 2 weeks, 1 month, 2-3 months and 6 months | Tracking height in Centimeters |
| Anemia | at 2weeks, 1 month, 2-3 months | Hemoglobin |
| Ferritin | at 2 weeks, 1 month, 2-3 months and 6 months | Ferritin |
| 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 |
| Evaluation of weight gain | at 2 weeks, 1 month, 2-3 months and 6 months | Tracking weight in Kilograms |
| Evaluation of abdominal inflammation | at 2 weeks and 2-3 months | Calprotectin level |
| Evaluation of intestinal microbiota | at 2-3 months | Fecal sequencing |
| Comorbidities | at 6 months | Number of retinopathy of prematurity (ROP) |
| 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 week during hospitalization then 1 time per 2 weeks until 6 months | Edin scale (0 (better outcome, no pain)-15 (worse outcome, pain)) |
| Therapeutic level | at 1 month, 2-3 months and 6 months | Number of patients needed to increase the iron substitution to a therapeutic level |
Countries
Switzerland
Contacts
Primary ContactCéline Ferraz
Backup ContactRiccardo E Pfister, MD, PHD
Outcome results
None listed