Iron Supplement
DrugThe 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
NCT Number: NCT06624709
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.
Interested in participating?
Request Info14 day–14 day
All sexes
Interventional
Not applicable
HUG, Geneva, Canton of Geneva, Switzerland
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 6 months
Hemoglobin level
Time frame: at 2weeks, 1 month, 2-3 months
Hemoglobin
Time frame: at 2weeks, 1 month, 2-3 months
Hematocrit level
Time frame: at 2 weeks, 1 month, 2-3 months and 6 months
Ferritin
Time frame: at 2 weeks, 1 month, 2-3 months and 6 months
Ret-Hb level
Time frame: at 1 month, 2-3 months and 6 months
Number of patients needed a transfusion
Time frame: at 1 month, 2-3 months and 6 months
Number of patients needed to increase the iron substitution to a therapeutic level
Time frame: at 2 weeks and 2-3 months
Calprotectin level
Time frame: at 2 weeks and 2-3 months
Hepcidin level
Time frame: at 2-3 months
Fecal sequencing
Time frame: at 6 months
Number of retinopathy of prematurity (ROP)
Time frame: at 6 months
Number of periventricular leukomalacia (PVL)
Time frame: at 6 months
Number of sepsis
Time frame: at 6 months
Number of intraventricular hemorrhage (IVH)
Time frame: at 6 months
Number of bronchopulmonary dysplasia (BPD)
Time frame: at 6 months
Number of necrotizing enterocolitis (NEC)
Time frame: at 2 weeks, 1 month, 2-3 months and 6 months
Tracking weight in Kilograms
Time frame: at 2 weeks, 1 month, 2-3 months and 6 months
Tracking height in Centimeters
Time frame: at 2 weeks, 1 month, 2-3 months and 6 months
Tracking head circumference in Centimeters
Time frame: 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))
Time frame: 3 times per day during hospitalization then 1 time per 2 weeks until 6 months
Classify stools with Bristol scale (1 (severe constipation) -7 (severe diarrhea))
Contact information is provided by the study sponsor or research team.
Céline Ferraz
CONTACT
Riccardo E Pfister, MD, PHD
CONTACT
Riccardo Pfister
Other
Acronym: BienFER
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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