Trial reportPediatric research2016
Safety and pharmacokinetics of multiple dose myo-inositol in preterm infants.
Trial report in Pediatric research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01030575 (Phase II Randomized, Double-Masked, Placebo-Controlled, Safety, Pharmacokinetic, and Dose-Ranging Study of Multiple Doses of Inositol in Premature Infants), which is not on this map. Cited by 17 papers, 3 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.
Phase II Randomized, Double-Masked, Placebo-Controlled, Safety, Pharmacokinetic, and Dose-Ranging Study of Multiple Doses of Inositol in Premature Infants
Who cites it
17 citing papers in PubMed, 3 syntheses or guidelines pooled it, 26 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
- Trial
- Screening of Unexplored FDA-approved Inactive Ingredients as Stabilizers for Monoclonal Antibody Products.Pharmaceutical research · 2026Article
- The role of nutritional interventions in the prevention and treatment of chronic lung disease of prematurity.Pediatric research · 2026Review
- AnCancer discovery · 2022Article
- Blood myo-inositol concentrations in preterm and term infants.Journal of perinatology : official journal of the California Perinatal Association · 2021Article
- A clinical study on plasma biomarkers for deciding the use of adjuvant corticosteroid therapy in bronchopulmonary dysplasia of premature infants.International journal of medical sciences · 2021Observational
- Overview of Inositol and Inositol Phosphates on Chemoprevention of Colitis-Induced Carcinogenesis.Molecules (Basel, Switzerland) · 2020Review
- Role of inositol to improve surfactant functions and reduce IL-6 levels: A potential adjuvant strategy for SARS-CoV-2 pneumonia?Medical hypotheses · 2020Article
- Respiratory metabolites in bronchoalveolar lavage fluid (BALF) and exhaled breath condensate (EBC) can differentiate horses affected by severe equine asthma from healthy horses.BMC veterinary research · 2020Article
- Inositol and antioxidant supplementation: Safety and efficacy in pregnancy.Diabetes/metabolism research and reviews · 2019Review
- Opportunities in posthemorrhagic hydrocephalus research: outcomes of the Hydrocephalus Association Posthemorrhagic Hydrocephalus Workshop.Fluids and barriers of the CNS · 2018Review
- Turkish Neonatal Society guideline on prevention and management of bronchopulmonary dysplasia.Turk pediatri arsivi · 2018Article
- Bronchopulmonary Dysplasia: An Update of Current Pharmacologic Therapies and New Approaches.Clinical medicine insights. Pediatrics · 2018Review
- Role of cytokines and treatment algorithms in retinopathy of prematurity.Current opinion in ophthalmology · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
26 authors at 18 institutions in 2 countries.
Funding
Abstract
backgroundPreterm infants with respiratory distress syndrome (RDS) given inositol had reduced bronchopulmonary dysplasia (BPD), death and severe retinopathy of prematurity (ROP). We assessed the safety and pharmacokinetics of daily inositol to select a dose providing serum levels previously associated with benefit, and to learn if accumulation occurred when administered throughout the normal period of retinal vascularization.
methodsInfants ≤ 29 wk GA (n = 122, 14 centers) were randomized and treated with placebo or inositol at 10, 40, or 80 mg/kg/d. Intravenous administration converted to enteral when feedings were established, and continued to the first of 10 wk, 34 wk postmenstrual age (PMA) or discharge. Serum collection employed a sparse sampling population pharmacokinetics design. Inositol urine losses and feeding intakes were measured. Safety was prospectively monitored.
resultsAt 80 mg/kg/d mean serum levels reached 140 mg/l, similar to Hallman's findings. Levels declined after 2 wk, converging in all groups by 6 wk. Analyses showed a mean volume of distribution 0.657 l/kg, clearance 0.058 l/kg/h, and half-life 7.90 h. Adverse events and comorbidities were fewer in the inositol groups, but not significantly so.
conclusionMultiple dose inositol at 80 mg/kg/d was not associated with increased adverse events, achieves previously effective serum levels, and is appropriate for investigation in a phase III trial.
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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.