Iron Overload Clinical Trial
Official title:
Iron Metabolism in Small Pre Term Newborns
Verified date | October 2019 |
Source | HaEmek Medical Center, Israel |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 6 Months |
Eligibility |
Inclusion Criteria: - Very Low Birth Weight and / or borne at 30 weeks or less of gestational age that are scheduled to receive enteral iron supplementation as part of the standard protocol currently used by the Neonatal Intensive Care Unit. - Birth weight will be not an inclusion or exclusion criteria for preterms born at 30 weeks or less. Exclusion Criteria: - Major physical anomalies, - renal or cardiac diseases, - newborns that underwent major surgery during the study period, - acute or chronic fetal blood loss, - hemolytic anemia, - refusal to receive parental consent. |
Country | Name | City | State |
---|---|---|---|
Israel | Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center | Afula |
Lead Sponsor | Collaborator |
---|---|
HaEmek Medical Center, Israel |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of iron status in preterm infants and identify which preterm infants are at risk for iron deficiency or iron overload. | 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. | One year |
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