Nutritional Status Clinical Trial
Official title:
New Versus Standard Enteral Iron Supplementation Regime in Very Low Birth Weight Infants - A Randomized Controlled Trial
To examine if early iron supplementation (starting oral iron at 14 days of life) would improve the nutritional iron status(measured by serum ferritin) of very low birth weight infants at postnatal age of 60 days, when compared to the standard regime of starting iron at 2 months of life.
Smaller the preterm infants at birth, more susceptible they are to iron deficiency due to
low body iron stores. Despite having low iron stores, very low birth weight (VLBW) infants
are not usually started on iron supplementation till they reach a postnatal age of 6 to 8
weeks. Such delayed supplementation can lead to rapid depletion of iron stores when
erythropoiesis becomes active (by 8 weeks of life).
Depletion of iron stores is the first step in the continuum of changes that occur in iron
deficiency. Iron deficiency induces biochemical defects (such as impaired synthesis of DNA
and collagen) even before any features of microcytic, hypochromic anemia become evident. The
rapidly maturing preterm brain is especially vulnerable to the effects of iron deficiency;
poor school-age performance has been reported among children who had low iron stores in
their neonatal period.
Early iron supplementation i.e. starting iron once the infant reaches full enteral feeds
could potentially improve the iron stores and prevent its depletion. Surprisingly, few
studies are available till date to support (or refute!) this view. The current study was
designed to test the hypothesis whether early iron supplementation would increase the
nutritional iron status (as measured by serum ferritin) at 60 days of life when compared to
the existing regime of starting iron at the age 2 months.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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