Theme: Abstract Submission
Topic: 03. Neonatology / Haematology & Oncology
Authors: S. Ricci - Paediatrics, G. Zorzi - Paediatrics, E. Gasparrini - Paediatrics, B. Perrone - Paediatrics, E. Lanfranchi - Paediatrics, G. Tarantino; Hospital of Jesi, Pediatrics and Neonatology Unit, Jesi, Italy, Hopsital of Ascoli Piceno, Pediatrics, Ascoli Piceno, Italy, Hospital of Macerata, Neonatology and Neonatal follow-up Unit, Macerata, Italy, Salesi Children's Hospital, Division of Neonatology and NICU, Ancona, Italy, Hospital of Fermo, Pediatrics and Neonatology, Fermo, Italy, Pharmanutra Spa, Scientific Department, Pisa, Italy
Abstract
Background and aims: The effects of iron deficiency on the developing brain are permanent and lifealtering.
Iron supplementation is recommended for preterm infants, but there are few data on the prevalence of iron deficiency for newborns with mild-to-moderate prematurity and small for gestational age (SGA). The aim of the study is to investigate the efficacy of prophylaxis with Sucrosomial Iron (SI) in mild-to-moderate preterm and in SGA infants.
Method: Interventional, placebo-controlled, randomized, double-blind, multicenter study. Infants born from 32+0 to 36+6 weeks of gestational age (both adequate weight and SGA) and SGA infants born at term were included. Recruited newborns were divided into 3 groups: Group A: placebo, Group B: 1.4 mg/kg/day of elemental iron from SI, Group C: 2.8 mg/kg/day of elemental iron from SI, from the 1st to the 6th month of life. Mild preterm infants <34+0 and SGA <36+6 weeks were excluded from the placebo arm.
Results: data from 116 infants are reported. Blood parameters at 6 months are showed in table 1 for all infants and for the subgroup of breastfed ones
Table 1
| All infants | Breastfed infants | |||||||
|---|---|---|---|---|---|---|---|---|
| Parameter | Group A | Group B | Group C | P value | Group A | Group B | Group C | P value |
| Hemoglobin (g/dL) | 11.37 ± 1.04 | 12.21 ± 0.90 | 11.90 ± 0.92 | 0.015 | 10.55 ± 1.61 | 12.11 ± 0.73 | 11.76 ± 1.06 | 0.05 |
| Ferritin (ng/ml) | 28 [14.75 - 43.02] | 25.6 [16.5 – 41.20] | 34.5 [20 – 47.05] | 0.585 | 5 [3.5-8] | 20 [9.7-44] | 30 [10.95 – 59.03] | 0.094 |
| Transferrin saturation (%) | 13.94 ± 6.83 | 15.51 ± 7.03 | 16.67 ± 8.04 | 0.476 | 8.80 ± 8.55 | 13.64 ± 7.63 | 16.15 ± 9.11 | 0.369 |
In conclusion, data of this ad interim analysis show that both treatments with SI ameliorate blood parameters in SGA and mild-to moderate preterm infants compared to placebo. The benefit of SI is better for those breastfed infants, who didnʼt receive other iron supplements from milk formula. More data and deeper analysis are needed to establish the best dose of Sucrosomi.al Iron for each population.
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