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

Обзор

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.

Вмешательства

• Препарат Iron 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

Первичные конечные точки

• Anemia at 6 months [Срок оценки: 6 months]

Вторичные конечные точки (12)

• Anemia [Срок оценки: at 2weeks, 1 month, 2-3 months]
• Anemia [Срок оценки: at 2weeks, 1 month, 2-3 months]
• Ferritin [Срок оценки: at 2 weeks, 1 month, 2-3 months and 6 months]
• Ret-Hb level [Срок оценки: at 2 weeks, 1 month, 2-3 months and 6 months]
• Transfusion [Срок оценки: at 1 month, 2-3 months and 6 months]
• Therapeutic level [Срок оценки: at 1 month, 2-3 months and 6 months]
• Evaluation of abdominal inflammation [Срок оценки: at 2 weeks and 2-3 months]
• Evaluation of abdominal inflammation [Срок оценки: at 2 weeks and 2-3 months]
• Evaluation of intestinal microbiota [Срок оценки: at 2-3 months]
• Comorbidities [Срок оценки: at 6 months]
• Comorbidities [Срок оценки: at 6 months]
• Comorbidities [Срок оценки: at 6 months]

Критерии участия

Критерии включения

• Premature babies between 28 0/7WA and 34 6/7 WA
• Parental consent, postnatal
• Age of 2 weeks

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Швейцария · 2 центра

• HUG — Geneva
• CHUV — Lausanne

Идентификаторы

NCT: NCT06624709 · 2021-02374

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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