Gentamicin Pharmacokinetics in Neonates Undergoing Therapeutic Hypothermia for Hypoxic Ischemic Encephalopathy.

Purpose: The purpose of this study was to review the pharmacokinetic profile of gentamicin among neonates with hypoxic ischemic encephalopathy (HIE) undergoing therapeutic hypothermia (TH) treatment.

Methods: This was a retrospective study of neonates with HIE undergoing TH in the neonatal intensive care unit who received gentamicin between 2009 and 2014. Demographic information, diagnoses, laboratory test results, and medication administration and monitoring information were collected, and data were analyzed using SciPy.

Decreasing Blood Transfusions in Premature Infants Through Quality Improvement.

Background And Objectives: Packed red blood cell transfusions (pRBCT) in preterm infants have been associated with significant morbidity. Although infants <26 weeks' gestational age typically require several pRBCT, preterm infants born between 26 and 34 weeks' gestational age may also require pRBCT during their hospitalization that are potentially preventable. We aimed to reduce pRBCT in this population by 20%.

Ventilation-Induced Lung Injury (VILI) in Neonates: Evidence-Based Concepts and Lung-Protective Strategies.

Supportive care with mechanical ventilation continues to be an essential strategy for managing severe neonatal respiratory failure; however, it is well known to cause and accentuate neonatal lung injury. The pathogenesis of ventilator-induced lung injury (VILI) is multifactorial and complex, resulting predominantly from interactions between ventilator-related factors and patient-related factors. Importantly, VILI is a significant risk factor for developing bronchopulmonary dysplasia (BPD), the most common chronic respiratory morbidity of preterm infants that lacks specific therapies, causes life-long morbidities, and imposes psychosocial and economic burdens.

A simple isocratic LC method for quantification of trace-level inorganic degradation impurities (ferricyanide, ferrocyanide, nitrite, and nitrate) in sodium nitroprusside injection and robustness by quality using design approach.

This study developed and validated a trace-level quantification inorganic impurities method using reversed-phase HPLC and performed the robustness check using quality-by-design approach by varying the multiple factors simultaneously. This method is economical and simple and exhibits its stability-indicating nature [for the determination of ferrocyanide ([Fe(CN)₆] ), ferricyanide ([Fe(CN) ] ), nitrate (NO ), and nitrite (NO )] in sodium nitroprusside (SNP) drug substance and liquid dosage form. Chromatographic separation was achieved using a USP L43 column (ACE PFP, 150 × 4.

A simple and rapid HPLC method for determination of parabens and their degradation products in pharmaceutical dosage forms.

A stability-indicating HPLC method was developed for the simultaneous determination of paraben mixture and its degradation products in effervescent potassium chloride tablets. The chromatographic separation was achieved on a Waters Cortecs C18 column (2.7 μm, 4.

Development and validation of LC-MS method for the determination of heptaethylene glycol monomethyl ether in benzonatate bulk drugs.

A simple and isocratic reverse-phase liquid chromatography with mass spectrometric method has been developed and validated for the determination of heptaethylene glycol monomethyl ether in benzonatate drug substance. Benzonatate is an oral antitussive drug used to relieve and suppress cough in patients older than 10 years. The presence of residual heptaethylene glycol monomethyl ether in the benzonatate drug substance affects the safety, strength, purity and quality of the drug substance.

Quality by design with design of experiments approach for development of a stability-indicating LC method for enzalutamide and its impurities in soft gel dosage formulation.

A novel ultra-performance liquid chromatographic (UPLC) method has been developed and approved for the quantitative determination of enzalutamide (ENZ) and its impurities in drug product dosage form by applying the quality by design with design of experiments approach. An efficient chromatographic separation was achieved on a Waters ACQUITY CSH C (100 × 2.1 mm × 1.

QbD based development of HPLC method for simultaneous quantification of Telmisartan and Hydrochlorothiazide impurities in tablets dosage form.

A simple reverse phase liquid chromatographic gradient method has been developed and validated for the simultaneous determination of specified & un-specified impurities of Telmisartan and Hydrochlorothiazide in combination oral solid dosage forms. The developed method is effective to separate a total of sixteen (16) peaks and quantify eleven (11) specified impurities of Telmisartan and three (3) specified impurities of Hydrochlorothiazide with a minimum chromatographic resolution of 2.5.

A novel RP-HPLC refractive index detector method development and validation for determination of trace-level alcohols (un-sulfated) in sodium lauryl sulfate raw material.

The main aim of the study is to develop and validate a simple and rapid liquid chromatographic analytical method for simultaneous determination of trace level of un-sulfated alcohol impurities in sodium lauryl sulfate using high-performance liquid chromatography with a refractive index detector. The chromatographic separation was achieved using flow rate of 3.0 ml/min with a Waters Symmetry C (150 × 4.

Mask versus Prongs for Nasal Continuous Positive Airway Pressure in Preterm Infants: A Systematic Review and Meta-Analysis.

Nasal continuous positive airway pressure (NCPAP) is an effective method of respiratory support for preterm infants. Nasal masks and binasal prongs are two interfaces available to deliver NCPAP, and it is unclear if one is superior to the other. We conducted a systematic review and meta-analysis, using the methodology recommended by the Cochrane Collaboration, to compare the efficacy and safety of nasal masks versus binasal prongs to deliver NCPAP in preterm infants <37 weeks of gestation.

Lowest PaCO2 on the first day of life predicts mortality and morbidity among infants with congenital diaphragmatic hernia.

Objective: To evaluate the association between hypercarbia in the first 24 h of life and clinical outcomes in infants with congenital diaphragmatic hernia (CDH).

Study Design: Retrospective review of patients entered into the CDHSG registry between 2007-2014. Half of the identified patients were analyzed to identify the PaCO2 value most predictive of mortality.

Identifying a quality improvement project.

An important step on the roadmap to a successful quality improvement (QI) project is careful selection of topics and aims to be addressed by QI projects. Using information from a variety of data monitoring systems as well as individual events and experiences, leaders of neonatal units and QI teams should first identify quality and safety gaps in their unit. They should then use an explicit, formal process for selecting the best projects to which their limited time and resources should be allocated.

Video Laryngoscopy vs. Direct Laryngoscopy in Teaching Neonatal Endotracheal Intubation: A Simulation-Based Study.

Background: Neonatal endotracheal intubation is a life-saving procedural skill where best practices have been developed from expert opinion. Few empirical studies have examined how this skill should be taught.

Objective: To determine whether a video laryngoscope (VL) assisted intubation training curriculum compared to a traditional direct laryngoscope (DL) assisted curriculum improves neonatal intubation performance of novice intubators in a simulated setting.

Predicting neonatal intubation competency in trainees.

Background And Objectives: Pediatric residency training programs are graduating residents who are not competent in neonatal intubation, a vital skill needed for any pediatrician involved in delivery room resuscitations. However, a precise definition of competency during training is lacking. The objective of this study was to more precisely define the trajectory toward competency in neonatal intubation for pediatric residents, as a framework for later evaluating complementary training tools.

Speaking up and sharing information improves trainee neonatal resuscitations.

Objectives: To identify teamwork behaviors associated with improving efficiency and quality of simulated resuscitation training.

Methods: Secondary analysis of a randomized controlled trial of trainees undergoing neonatal resuscitation training was performed. Trainees at a large academic center (n = 100) were randomized to receive standard curriculum (n = 36) versus supplemental team training curriculum (n = 62).

Treatment of patent ductus arteriosus with bidirectional flow in neonates.

Background: Patent ductus arteriosus is a common occurrence among prematurely born neonates and is believed to play a role in the development of other complications of prematurity including intraventricular hemorrhage, bronchopulmonary dysplasia, and necrotizing enterocolitis. The clinical decision to treat the patent ductus arteriosus is complicated by the lack of evidence available regarding clinical conditions under which closure should be attempted.

Study Aims: To compare clinical outcomes for neonates who underwent treatment of patent ductus arteriosus exhibiting bidirectional blood flow versus those with flow that was left to right.

Safety and effectiveness of indomethacin versus ibuprofen for treatment of patent ductus arteriosus.

We compared the rates of medical closure of patent ductus arteriosus (PDA) and complications (renal dysfunction, necrotizing enterocolitis, spontaneous intestinal perforation, and intraventricular hemorrhage) between infants treated with indomethacin and infants treated with ibuprofen. We performed a retrospective comparative cohort study of infants treated with indomethacin or ibuprofen for symptomatic PDA at Duke University Medical Center between November 2005 and November 2007. We identified 65 infants who received indomethacin and 57 who received ibuprofen.