Early versus late enteral prophylactic iron supplementation in preterm very low birth weight infants: a randomised controlled trial

OBJECTIVES: To evaluate whether preterm very low birth weight (VLBW) infants receiving early iron (EI) supplementation (2 mg/kg/day elemental iron) at 2 weeks postnatal age have improved serum ferritin levels compared with late iron (LI) supplementation at 6 weeks postnatal age. DESIGN: Single-blinded parallel-group interventional randomised controlled trial. SETTING: Tertiary care centre in southern India. INTERVENTIONS: Randomised at 2 weeks postnatal age to EI and LI groups and evaluated at 2, 6 and 12 weeks postnatal age. OUTCOME: The primary outcome was serum ferritin level at 12 weeks, and the secondary outcomes were the incidence of neonatal morbidities, haemoglobin level, anthropometric parameters and blood transfusion requirements. RESULTS: Of the 104 babies randomised, outcomes were analysed in 46 and 47 babies in EI and LI groups, respectively. Serum ferritin level was significantly higher (p<0.001) at 12 weeks (82±5 vs 63±3 ng/mL) in the EI group. Haemoglobin (10.1±0.4 vs 9.2±0.4 g/dL) and mean corpuscular haemoglobin concentration (31±0.5 vs 29.4±0.5 g/dL) were also significantly (p<0.001) higher at 12 weeks in the EI group. There was a significant decrease of ferritin in the LI group and significant increase in ferritin in the EI group at 6 weeks compared with 2 weeks. There were no significant differences in the incidences of neonatal morbidities (necrotising enterocolitis, periventricular leukomalacia, retinopathy of prematurity), anthropometric parameters and blood transfusion requirements between the two groups. CONCLUSIONS: EI supplementation in preterm VLBW infants improves serum ferritin and haemoglobin levels. TRIAL REGISTRATION: CTRI/2013/01/003277.