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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alternate (4 times/week) iron supplementation | Active Comparator | This arm will receive 2-3mg/kg/d of maltofer 4 times a day |
|
| Daily iron substitution | Sham Comparator | This arm will receive 2-3mg/kg/d of maltofer 7 times per week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron Supplement | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Anemia at 6 months | Hemoglobin level | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Anemia | Hemoglobin | at 2weeks, 1 month, 2-3 months |
| Anemia | Hematocrit level | at 2weeks, 1 month, 2-3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Céline Ferraz | Contact | +41 79 553 84 54 | celine.ferraz@hcuge.ch | |
| Riccardo E Pfister, MD, PHD | Contact | +41 79 553 44 38 | riccardo.pfister@hug.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HUG | Recruiting | Geneva | Canton of Geneva | 1211 | Switzerland |
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| Ferritin | Ferritin | at 2 weeks, 1 month, 2-3 months and 6 months |
| Ret-Hb level | Ret-Hb level | at 2 weeks, 1 month, 2-3 months and 6 months |
| Transfusion | Number of patients needed a transfusion | at 1 month, 2-3 months and 6 months |
| Therapeutic level | Number of patients needed to increase the iron substitution to a therapeutic level | at 1 month, 2-3 months and 6 months |
| Evaluation of abdominal inflammation | Calprotectin level | at 2 weeks and 2-3 months |
| Evaluation of abdominal inflammation | Hepcidin level | at 2 weeks and 2-3 months |
| Evaluation of intestinal microbiota | Fecal sequencing | at 2-3 months |
| Comorbidities | Number of retinopathy of prematurity (ROP) | at 6 months |
| Comorbidities | Number of periventricular leukomalacia (PVL) | at 6 months |
| Comorbidities | Number of sepsis | at 6 months |
| Comorbidities | Number of intraventricular hemorrhage (IVH) | at 6 months |
| Comorbidities | Number of bronchopulmonary dysplasia (BPD) | at 6 months |
| Comorbidities | Number of necrotizing enterocolitis (NEC) | at 6 months |
| Evaluation of weight gain | Tracking weight in Kilograms | at 2 weeks, 1 month, 2-3 months and 6 months |
| Evaluation of height gain | Tracking height in Centimeters | at 2 weeks, 1 month, 2-3 months and 6 months |
| Evaluation of the growth's parameter | Tracking head circumference in Centimeters | at 2 weeks, 1 month, 2-3 months and 6 months |
| Evaluation of abdominal discomfort | Edin scale (0 (better outcome, no pain)-15 (worse outcome, pain)) | 3 times per week during hospitalization then 1 time per 2 weeks until 6 months |
| Evaluation of abdominal discomfort | Classify stools with Bristol scale (1 (severe constipation) -7 (severe diarrhea)) | 3 times per day during hospitalization then 1 time per 2 weeks until 6 months |
| CHUV | Recruiting | Lausanne | Canton of Vaud | 1011 | Switzerland |
|
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D007505 | Iron-Dextran Complex |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003911 | Dextrans |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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