Neurological development and iron supplementation in healthy late-preterm neonates: a randomized double-blind controlled trial

R Luciano; D M Romeo; G Mancini; S Sivo; C Dolci; C Velli; A Turriziani Colonna; G Vento; C Romagnoli; E M Mercuri

doi:10.1007/s00431-021-04181-1

Neurological development and iron supplementation in healthy late-preterm neonates: a randomized double-blind controlled trial

Eur J Pediatr. 2022 Jan;181(1):295-302. doi: 10.1007/s00431-021-04181-1. Epub 2021 Jul 21.

Authors

R Luciano¹, D M Romeo², G Mancini³, S Sivo², C Dolci³, C Velli², A Turriziani Colonna³, G Vento⁴, C Romagnoli⁵, E M Mercuri⁶

Affiliations

¹ Neonatology Unit, Department of Woman and Child Health and Public Health, Child Health Area, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Catholic University of Sacred Heart, Rome, Italy. ritapaolamaria.luciano@policlinicogemelli.it.
² Pediatric Neurology Unit, Fondazione Policlinico A. Gemelli IRCCS, Rome, Italy.
³ Department of Woman and Child Health and Public Health, Child Health Area, Catholic University of Sacred Heart, Rome, Italy.
⁴ Neonatology Unit, Department of Woman and Child Health and Public Health, Child Health Area, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Catholic University of Sacred Heart, Rome, Italy.
⁵ Neonatology Unit, Department of Woman and Child Health and Public Health, Child Health Area, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome, Italy.
⁶ Pediatric Neurology Unit, Department of Woman and Child Health and Public Health, Child Health Area, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Catholic University of Sacred Heart, Rome, Italy.

Abstract

Late-preterm infants (LPT) are at increased risk for long-term neurodevelopmental sequelae and iron deficiency. The aim of the study is to assess the positive effect of iron supplementation on psychomotor development in healthy LPT. We designed a randomized placebo-controlled double-blind trial dividing the newborns into two groups. Every patient was assessed using the Griffiths Mental Development Scales (GMDS)-II edition at 12-month post-conceptional age. The study was performed at the Neonatology Unit of our Hospital, in Italy. Sixty-six healthy LPT infants born between 34^0⁄7 and 36^6⁄7 weeks of gestational age were enrolled in the study. One group received martial prophylaxis from the third week of life to 6 months of post-conceptional age (2 mg/kg/day of iron pidolate), the other received placebo. Fifty-two of the enrolled infants were assessed using the GMDS at 12-month of post-conceptional age. Statistical analysis of the mean scores of the Griffiths subscales was performed. There was a difference in the mean developmental quotient (DQ) (p < 0.01) between the two groups: iron group mean DQ 121.45 ± 10.53 vs placebo group mean DQ 113.25 ± 9.70. Moreover, mean scores of the Griffiths subscales A, B, and D showed significant differences between the two groups (scale A p < 0.05, scale B p < 0.02, scale D p < 0.01, respectively).Conclusions: We recommend that all LPT neonates receive iron supplementation during the first 6 months of life in order to improve their 1-year neurodevelopmental quotient. What is Known: • Late-preterm infants (LPT) are at increased risk for long-term neurodevelopmental sequelae and also for iron deficiency. • Iron deficiency is an independent risk factor for adverse neurological outcomes. What is New: • Healthy late-preterm who received iron supplementation during the first 6 months of life achieved better neurological outcomes at 12-month post-conceptional age than LPT who received placebo. • Our study strongly supports the need for the implementation of martial prophylaxis in LPT neonates.

Keywords: Iron deficiency; Iron supplementation; Late preterm; Psychomotor development.

Publication types

Randomized Controlled Trial

MeSH terms

Dietary Supplements
Gestational Age
Humans
Infant
Infant, Newborn
Infant, Premature
Iron Deficiencies*
Iron*

Substances

Iron