Single blinded parallel group interventional randomised control trial to assess the benefits of early iron supplementation at 2 weeks post gestational age in preterm very low birth weight infants.

The effects of iron deficiency are extensive and involve multiple organ systems. Poor physical growth, gastrointestinal disturbances, thyroid dysfunction, altered immunity and temperature instability has been attributed to iron deficiency in very low birth weight (VLBW, birth weight <1500g) infants. Anaemia, a late sign of iron deficiency, signals significant depletion of iron stores, causing significant structural and functional impairments in neurodevelopment as well as long-term cognitive abnormalities, seemingly irreversible even with iron supplementation. Maternal-fetal iron transport predominantly takes place in the third trimester, making premature birth a potential factor leading to significant iron deficiency during a crucial phase of neurodevelopment.Early iron (EI) supplementation holds the potential to enhance iron stores and avert depletion. The optimal timing for commencing prophylactic enteral iron supplementation in preterm very low birth weight (VLBW) infants is debated internationally by various bodies, with recommendations spanning from 2 to 8 weeks, and the resolution of this matter is yet to be achieved.Most international bodies also recommend delayed initiation of prophylactic enteral iron supplementation considering the potentially increased risk of free radical mediated morbidities in preterm neonates. However, in earlier studies there was no evidence of adverse effects after early enteral iron supplementation. Moreover previous studies using serum ferritin as an outcome measure have yielded conflicting results on the benefits of early supplementation of iron. SF, while a reliable biomarker for iron, is also an acute phase protein elevated during systemic inflammation, potentially masking the presence of iron deficiency.In such situations, the Reticulocyte Haemoglobin Equivalent (RET-He) emerges as a more valuable and an early marker unaffected by inflammation and infection. RET-He value reflects the iron available for production of red blood cells which recently released from bone marrow in the previous 3–4 days. This lets us detect changes in iron status far earlier unlike traditional haematological parameters like HGB, MCV, MCH, or HYPO-He, which may indicate iron deficiencies relatively late. The clinical utility of RET-He as an early marker with cut off <29pg for iron deficiency anaemia has been established, with high sensitivity, specificity, and negative predictive values,making ita valuable parameter in advanced haematological analysis. Hence, a study is essential to examine the benefits of early iron supplementation (at 2 weeks postnatal age) in preterm very low birth weight (VLBW) infants, as compared with late supplementation at 4 weeks, with RET-He serving as the primary outcome measure.