Early versus late enteral prophylactic iron supplementation in preterm very low birth weight infants: a randomised controlled trial.
Study Goal
To determine whether early iron supplementation (2 mg/kg/day) at 2 weeks postnatal age improves serum ferritin levels compared to late supplementation at 6 weeks in preterm very low birth weight infants.
Results Summary
Early iron supplementation significantly increased serum ferritin and hemoglobin levels at 12 weeks compared to late supplementation, with no significant differences in neonatal morbidities, anthropometric parameters, or transfusion requirements between groups.
Population
Preterm very low birth weight (VLBW) infants in a tertiary care center in southern India.
Effective Dosage
2 mg/kg/day elemental iron
Duration
From 2 weeks to 12 weeks postnatal age
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
early iron (EI) supplementation (2 mg/kg/day elemental iron) at 2 weeks postnatal age | increase | serum ferritin level at 12 weeks | preterm very low birth weight (VLBW) infants | 82±5 vs 63±3 ng/mL | significantly higher | #1 |
early iron (EI) supplementation (2 mg/kg/day elemental iron) at 2 weeks postnatal age | increase | haemoglobin at 12 weeks | preterm very low birth weight (VLBW) infants | 10.1±0.4 vs 9.2±0.4 g/dL | significantly higher | #2 |
early iron (EI) supplementation (2 mg/kg/day elemental iron) at 2 weeks postnatal age | increase | mean corpuscular haemoglobin concentration at 12 weeks | preterm very low birth weight (VLBW) infants | 31±0.5 vs 29.4±0.5 g/dL | significantly higher | #3 |
late iron (LI) supplementation at 6 weeks postnatal age | decrease | ferritin at 6 weeks compared with 2 weeks | preterm very low birth weight (VLBW) infants | - | significant decrease | #4 |
early iron (EI) supplementation (2 mg/kg/day elemental iron) at 2 weeks postnatal age | increase | ferritin at 6 weeks compared with 2 weeks | preterm very low birth weight (VLBW) infants | - | significant increase | #5 |
early iron (EI) supplementation (2 mg/kg/day elemental iron) at 2 weeks postnatal age | no change | incidences of neonatal morbidities (necrotising enterocolitis, periventricular leukomalacia, retinopathy of prematurity) | preterm very low birth weight (VLBW) infants | - | no significant differences | #6 |
early iron (EI) supplementation (2 mg/kg/day elemental iron) at 2 weeks postnatal age | no change | anthropometric parameters | preterm very low birth weight (VLBW) infants | - | no significant differences | #7 |
early iron (EI) supplementation (2 mg/kg/day elemental iron) at 2 weeks postnatal age | no change | blood transfusion requirements | preterm very low birth weight (VLBW) infants | - | no significant differences | #8 |
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.