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Article
Blood myo-inositol concentrations in preterm and term infants
To describe relationship between cord blood (representing fetal) myo-inositol concentrations and gestational age (GA) and to determine trends of blood concentrations in enterally and parenterally fed infants from...
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Article
Dose-escalation trial of budesonide in surfactant for prevention of bronchopulmonary dysplasia in extremely low gestational age high-risk newborns (SASSIE)
Initial trials of lung-targeted budesonide (0.25 mg/kg) in surfactant to prevent bronchopulmonary dysplasia (BPD) in premature infants have shown benefit; however, the optimal safe dose is unknown.
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Article
Administration of Inhaled Pulmonary Vasodilators to the Mechanically Ventilated Neonatal Patient
Pulmonary hypertension is a life-threatening condition that affects people of all ages that can occur as an idiopathic disorder at birth or as part of a variety of cardiovascular and infectious disorders. It i...
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Article
Open AccessSafety, dosing, and pharmaceutical quality for studies that evaluate medicinal products (including biological products) in neonates
The study of medications among pediatric patients has increased worldwide since 1997 in response to new legislation and regulations, but these studies have not yet adequately addressed the therapeutic needs of...
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Article
Safety and pharmacokinetics of multiple dose myo-inositol in preterm infants
Preterm 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 pharmacokinet...
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Article
Open AccessIncorporating pharmacodynamic considerations into caffeine therapeutic drug monitoring in preterm neonates
This study sought to assess the pharmacokinetic and pharmacodynamic relationships of caffeine citrate therapy in preterm neonates who had therapeutic drug monitoring (TDM) in the post-extubation period.
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Article
Challenges Associated with Route of Administration in Neonatal Drug Delivery
The administration of drugs to neonates poses significant challenges. The aim of this review was to provide insight into some of these challenges and resolutions that may be encountered with several of the mo...
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Article
Population Pharmacokinetics of Darbepoetin Alfa in Conjunction with Hypothermia for the Treatment of Neonatal Hypoxic-Ischemic Encephalopathy
The aim of this study was to determine the population pharmacokinetics of darbepoetin alfa in hypothermic neonates with hypoxic-ischemic encephalopathy treated with hypothermia.
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Article
Darbepoetin administration to neonates undergoing cooling for encephalopathy: a safety and pharmacokinetic trial
Despite therapeutic hypothermia, neonates with encephalopathy (NE) have high rates of death or disability. Darbepoetin alfa (Darbe) has comparable biological activity to erythropoietin, but has extended circul...
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Article
Ethics of Drug Studies in the Newborn
Drug studies in develo** pediatric patients, especially newborns, create many ethical challenges that can be analyzed in terms of respect for persons, justice, and beneficence/maleficence as outlined in the ...
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Article
Pharmacokinetics and Pharmacodynamics of Antibacterials, Antifungals, and Antivirals Used Most Frequently in Neonates and Infants
Antimicrobials and antivirals are widely used in young infants and neonates. These patients have historically been largely excluded from clinical trials and, as a consequence, the pharmacokinetics and pharmaco...
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Article
Pharmacokinetics and safety of a single intravenous dose of myo-inositol in preterm infants of 23–29 wk
Myo-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. Ph...
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Article
Open AccessProton Pump Inhibitors in Pediatrics
Proton pump inhibitors (PPIs) have become some of the most frequently prescribed medications for treatment of adults and children. Their effectiveness for treatment of peptic conditions in the pediatric popula...
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Article
Randomized, Open-Label, Multicentre Pharmacokinetic Studies of Two Dose Levels of Pantoprazole Granules in Infants and Children Aged 1 Month through <6 Years with Gastro-Oesophageal Reflux Disease
Background and Objective: The primary objective of this study was to characterize the pharmacokinetic profile of pantoprazole delayed-release granules in infants and children aged 1 month to <6 y...
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Article
Single-dose, multiple-dose, and population pharmacokinetics of pantoprazole in neonates and preterm infants with a clinical diagnosis of gastroesophageal reflux disease (GERD)
The pharmacokinetic profile of pantoprazole granules was assessed in neonates and preterm infants with gastroesophageal reflux disease (GERD) in a multicenter, randomized, open-label trial.
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Article
Opioid Tolerance to Sedation and Analgesia
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Article
Adaptation of Fetal Pulmonary Blood Flow to Local Infusion of Tolazoline
ABSTRACT: Although tolazoline is the most commonly used drug in the treatment of neonatal pulmonary hypertension, its mode of action and efficacy remain incompletely understood. In order to study the effects o...
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Article
227 ADAPTATION OF FETAL PULMONARY BLOOD FLOW TO LOCAL INFUSION OF TOLAZOLINE
To study the direct effect of tolazoline (T) in a high resistance pulmonary vascular bed, we infused T in nine chronically prepared fetal sheep with and without calcium channel blockade. An electromagnetic flo...
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Article
422 TOLAZOLINE (T) INDUCED OLIGURIA
T therapy of neonates has been associated with oliguria and renal failure which has not been studied thoroughly. We have reported T dosing in lambs to rapidly reach steady state (SS) plasma T concentrations. T...
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Article
TOLAZOLINE (T) DOSE ADJUSTMENTS BASED UPON NEONATAL PHARMACOKINETICS
T doses in current clinical use were derived without pharmacokinetic studies in infants. We developed a chemically-specific assay for T and measured its pharmacokinetics following pulse and infusion doses (n=1...
