Trial reportPediatric research2013
Pharmacokinetics and safety of a single intravenous dose of myo-inositol in preterm infants of 23-29 wk.
Trial report in Pediatric research, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 15 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
15 citing papers in PubMed, 4 syntheses or guidelines pooled it, 25 citations in OpenAlex.
- Eligibility Criteria and Representativeness of Randomized Clinical Trials That Include Infants Born Extremely Premature: A Systematic Review.The Journal of pediatrics · 2021Pooled it
- Inositol in preterm infants at risk for or having respiratory distress syndrome.The Cochrane database of systematic reviews · 2019Pooled it
- The efficacy and safety of inositol supplementation in preterm infants to prevent retinopathy of prematurity: a systematic review and meta-analysis.BMC ophthalmology · 2019Pooled it
- A systematic review of randomized controlled trials for the prevention of bronchopulmonary dysplasia in infants.Journal of perinatology : official journal of the California Perinatal Association · 2014Pooled it
- Trial
- Safety and pharmacokinetics of multiple dose myo-inositol in preterm infants.Pediatric research · 2016Trial
- Strategies for the prevention of bronchopulmonary dysplasia.Frontiers in pediatrics · 2024Review
- Pharmacokinetics ofInternational journal of molecular sciences · 2022Article
- Pharmacotherapy in Bronchopulmonary Dysplasia: What Is the Evidence?Frontiers in pediatrics · 2022Review
- Blood myo-inositol concentrations in preterm and term infants.Journal of perinatology : official journal of the California Perinatal Association · 2021Article
- Role of inositol to improve surfactant functions and reduce IL-6 levels: A potential adjuvant strategy for SARS-CoV-2 pneumonia?Medical hypotheses · 2020Article
- Opportunities in posthemorrhagic hydrocephalus research: outcomes of the Hydrocephalus Association Posthemorrhagic Hydrocephalus Workshop.Fluids and barriers of the CNS · 2018Review
- Methodological issues in the design and analyses of neonatal research studies: Experience of the NICHD Neonatal Research Network.Seminars in perinatology · 2016Article
- Quantification of myo-inositol, 1,5-anhydro- D-sorbitol, and D-chiro-inositol using high-performance liquid chromatography with electrochemical detection in very small volume clinical samples.Biomedical chromatography : BMC · 2015Article
- Inositol Analysis by HPLC and Its Stability in Scavenged Sample Conditions.Medicinal chemistry · 2015Article
Corrections and comments
- Erratum issued
- Erratum issued
Authors and funding
24 authors at 17 institutions in 2 countries.
Funding
Abstract
backgroundMyo-inositol given to preterm infants with respiratory distress has reduced death, increased survival without bronchopulmonary dysplasia, and reduced severe retinopathy of prematurity in two randomized trials. Pharmacokinetic (PK) studies in extremely preterm infants are needed before efficacy trials.
methodsInfants born in 23-29 wk of gestation were randomized to a single intravenous (i.v.) dose of inositol at 60 or 120 mg/kg or placebo. Over 96 h, serum levels (sparse sampling population PK) and urine inositol excretion were determined. Population PK models were fit using a nonlinear mixed-effects approach. Safety outcomes were recorded.
resultsA single-compartment model that included factors for endogenous inositol production, allometric size based on weight, gestational age strata, and creatinine clearance fit the data best. The central volume of distribution was 0.5115 l/kg, the clearance was 0.0679 l/kg/h, endogenous production was 2.67 mg/kg/h, and the half-life was 5.22 h when modeled without the covariates. During the first 12 h, renal inositol excretion quadrupled in the 120 mg/kg group, returning to near-baseline value after 48 h. There was no diuretic side effect. No significant differences in adverse events occurred among the three groups (P > 0.05).
conclusionA single-compartment model accounting for endogenous production satisfactorily described the PK of i.v. inositol.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.