Inositol for respiratory distress syndrome in preterm infants.

ABSTRACT

BACKGROUND: Inositol is an essential nutrient required by human cells in culture for growth and survival. Inositol promotes maturation of several components of surfactant and may play a critical role in fetal and early neonatal life. OBJECTIVES: To assess the effectiveness/safety of supplementary inositol in preterm infants with respiratory distress syndrome (RDS) in reducing adverse neonatal outcomes. SEARCH METHODS: The Cochrane Central Register of Controlled Trials (The Cochrane Library), MEDLINE, EMBASE, CINAHL, Clinicaltrials.gov and Controlled-trials.com were searched in May, 2011. The reference lists of identified randomized controlled trials (RCTs), personal files and Web of Science were searched. SELECTION CRITERIA All RCTs of inositol supplementation to preterm infants with a control group that received a placebo or no intervention were included. Outcomes of interest were neonatal death, infant death, bronchopulmonary dysplasia (BPD), retinopathy of prematurity (ROP), intraventricular hemorrhage (IVH), necrotizing enterocolitis (NEC), and sepsis. DATA COLLECTION AND ANALYSIS: Data on neonatal outcomes were abstracted independently by the three review authors and any discrepancy was resolved through consensus. Outcomes were reported as relative risk (RR), risk difference (RD) and number needed to treat to benefit (NNT). MAIN RESULTS: Four published and one ongoing randomized controlled trials were identified. Study quality varied and interim analyses had occurred in all trial that provided data for the outcomes. Neonatal death was found to be significantly reduced [three trials, 355 neonates, typical RR 0.53 (95% CI 0.31 to 0.91); RD -0.09 (95% CI -0.17 to -0.03); NNT 11 (95% CI 6 to 33). Infant deaths were reduced [three trials, 355 infants, typical RR 0.55 (95% CI 0.40 to 0.77); RD -0.18 (95% CI -0.27 to -0.08); NNT 6 (95% CI 4 to 13). ROP, stage ≥ 3 was significantly reduced [two trials, 262 infants, typical RR 0.09 (95% CI 0.01 to 0.67); typical RD -0.08 (95% CI -0.13 to -0.03); NNT 13 (95% CI 8 to 33)]. IVH grade > II was significantly decreased [three trials, 355 infants typical RR 0.53 (95% CI 0.31 to 0.90; typical RD -0.09 (95% CI -0.16 to -0.02); NNT 11 (95% CI 6 to 50). Neither sepsis nor NEC differed significantly between groups. One ongoing pharmacokinetics study of inositol in preterm infants was identified. AUTHORS' CONCLUSIONS: Inositol supplementation results in statistically significant and clinically important reductions in important short-term adverse neonatal outcomes. A multicenter randomized controlled trial of appropriate size is justified to confirm these findings.