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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Anemia at 6 months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 14 Days 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Premature babies between 28 0/7WA and 34 6/7 WA
- •Parental consent, postnatal
- •Age of 2 weeks
排除标准
- •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
研究组 & 干预措施
Alternate (4 times/week) iron supplementation
This arm will receive 2-3mg/kg/d of maltofer 4 times a day
干预措施: Iron Supplement (Drug)
Daily iron substitution
This arm will receive 2-3mg/kg/d of maltofer 7 times per week.
干预措施: Iron Supplement (Drug)
结局指标
主要结局
Anemia at 6 months
时间窗: 6 months
Hemoglobin level
次要结局
- 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)
研究者
Riccardo Pfister
Head of neonatology department, Principal Investigator, Clinical Professor
University Hospital, Geneva