Iron Metabolism in Small Pre Term Newborns
Recruitment status was Recruiting
Iron is an essential micronutrient that plays an important role in cellular functions of all microorganisms. Both iron deficiency and iron excess during the early weeks of life can have severe effects on neurodevelopment that may persist into adulthood and may not be corrected by restoration of normal iron levels.
Iron overload remains a significant concern in preterm infants because they have low levels of iron-binding proteins and immature antioxidant systems.
The aim of the study is to evaluate if iron supplementation is required/necessary in VLBW Very Low Birth Weight (less than 1500 grams) and to assess the efficacy and safety of the iron supplementation practice for VLBW preterm infants as implemented in the Neonatal Intensive Care Unit (NICU) at the Ha'Emek Medical Center, Afula, Israel.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Iron Metabolism in Small Pre Term Newborns|
- Assessment of iron status in preterm infants and identify which preterm infants are at risk for iron deficiency or iron overload. [ Time Frame: One year ] [ Designated as safety issue: Yes ]Assessment of the iron status in preterm infants and correlated them with clinical parameters: the blood transfusions given and the amount of blood obtained for routine laboratory analysis, and amount of daily iron intake through diet (human milk or formula)and identify which preterm infants are at risk for iron deficiency or iron overload.
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: Iron suplementation
Iron supplementation with IPC in a dose of 4 mg/kg/day of elemental iron started not before 4 weeks of age and as soon as 120 ml/kg/day of enteral feedings is tolerated given together with the first morning meal
Drug: Iron preparation
Iron supplementation with IPC in a dose of 4 mg/kg/day of elemental iron started not before 4 weeks of age and as soon as 120 ml/kg/day of enteral feedings is tolerated given together with the first morning meal. Serum samples will be obtained at 3 different times:
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01443195
|Contact: Ariel Koren, MD||972-4-6495576 ext firstname.lastname@example.org|
|Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center||Recruiting|
|Afula, Israel, 18101|
|Contact: Ariel Koren, MD 972-4-6495576 ext 5576 email@example.com|
|Sub-Investigator: Ariel Koren, MD|
|Principal Investigator: Carina Levin, MD|