Alexandra Howlett1, Arne Ohlsson, Nishad Plakkal. 1. Department of Pediatrics,Division ofNeonatology, FoothillsMedicalCentre,Calgary,Canada. alixe.howlett@albertahealthservices.ca.
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.
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, infantdeath, 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.
Authors: Daniel J Raiten; Alison L Steiber; Susan E Carlson; Ian Griffin; Diane Anderson; William W Hay; Sandra Robins; Josef Neu; Michael K Georgieff; Sharon Groh-Wargo; Tanis R Fenton Journal: Am J Clin Nutr Date: 2016-01-20 Impact factor: 7.045
Authors: Dale L Phelps; Kristi L Watterberg; Tracy L Nolen; Carol A Cole; C Michael Cotten; William Oh; Brenda B Poindexter; Kristin M Zaterka-Baxter; Abhik Das; Conra Backstrom Lacy; Ann Marie Scorsone; Michele C Walsh; Edward F Bell; Kathleen A Kennedy; Kurt Schibler; Gregory M Sokol; Matthew M Laughon; Satyanarayana Lakshminrusimha; William E Truog; Meena Garg; Waldemar A Carlo; Abbot R Laptook; Krisa P Van Meurs; David P Carlton; Amanda Graf; Sara B DeMauro; Luc P Brion; Seetha Shankaran; Faruk H Orge; Richard J Olson; Helen Mintz-Hittner; Michael B Yang; Kathryn M Haider; David K Wallace; Mina Chung; Denise Hug; Irena Tsui; Martin S Cogen; John P Donahue; Michael Gaynon; Amy K Hutchinson; Don L Bremer; Graham Quinn; Yu-Guang He; William R Lucas; Timothy W Winter; Stephen D Kicklighter; Kartik Kumar; Patricia R Chess; Tarah T Colaizy; Anna Marie Hibbs; Namasivayam Ambalavanan; Heidi M Harmon; Elisabeth C McGowan; Rosemary D Higgins Journal: JAMA Date: 2018-10-23 Impact factor: 56.272
Authors: Dale L Phelps; Robert M Ward; Rick L Williams; Kristi L Watterberg; Abbot R Laptook; Lisa A Wrage; Tracy L Nolen; Timothy R Fennell; Richard A Ehrenkranz; Brenda B Poindexter; C Michael Cotten; Mikko K Hallman; Ivan D Frantz; Roger G Faix; Kristin M Zaterka-Baxter; Abhik Das; M Bethany Ball; T Michael O'Shea; Conra Backstrom Lacy; Michele C Walsh; Seetha Shankaran; Pablo J Sánchez; Edward F Bell; Rosemary D Higgins Journal: Pediatr Res Date: 2013-09-04 Impact factor: 3.756