Neonates

Risk Factors and In-Hospital Outcomes Following Tracheostomy in Infants

Posted on by Kayla Korzekwinski

The Journal of Pediatrics • June 2017

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Lee JH, Smith PB, Quek MBH, Laughon MM, Clark RH, Hornik CP

This study analyzed an electronic medical record from 348 NICUs from 1997–2012 and evaluated the associations between infant demographics, diagnoses, and pre-tracheostomy cardio-pulmonary support with in-hospital mortality. It also determined the trends in use of infant tracheostomy over time. Tracheostomy is uncommonly performed in hospitalized infants, but the associated mortality is high. Risk factors for increased in-hospital mortality after tracheostomy include GA near term, SGA, and pulmonary diagnoses.

Effectiveness of Granulocyte Colony-Stimulating Factor in Hospitalized Infants with Neutropenia

Posted on by Kayla Korzekwinski

American Journal of Perinatology • April 2017

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Lee JA, Sauer B, Tuminski W, Cheong J, Fitz-Henley J 2nd, Mayers M, Ezuma-Igwe C, Arnold C, Hornik CP, Clark RH, Benjamin DK Jr, Smith PB, Ericson JE; Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee.

The objective of this study was to determine the time to hematologic recovery and the incidence of secondary sepsis and mortality among neutropenic infants treated or not treated with granulocyte colony-stimulating factor (G-CSF). We identified all neutropenic infants discharged from 348 neonatal intensive care units from 1997 to 2012. Neutropenia was defined as an absolute neutrophil count ≤ 1,500/µL for ≥ 1 day during the first 120 days of life.

Respiratory Support for Very Low Birth Weight Infants Receiving Dexamethasone

Posted on by Kayla Korzekwinski

The Journal of Pediatrics • April 2017

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Virkud YV, Hornik CP, Benjamin DK, Laughon MM, Clark RH, Greenberg RG, Smith PB.

To assess how neonatal intensive care units followed the American Academy of Pediatrics guidelines for use of dexamethasone in preterm infants by evaluating respiratory support at the time of dexamethasone administration. This is an observational study of infants discharged from one of 290 neonatal intensive care units from 2003 to 2010. The cohort included very low birth weight (<1500 g birth weight) infants born at ≤32 weeks gestational age. The main outcome was respiratory support at time of exposure to dexamethasone.

Risk factors for group B streptococcal disease in neonates of mothers with negative antenatal testing

Posted on by Kayla Korzekwinski

Journal of Perinatology • February 2017

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Parente V, Clark RH, Ku L, Fennell C, Johnson M, Morris E, Romaine A, Benjamin DK, Smith PB, Greenberg R

The aim of this study was to identify risk factors for early-onset group B Streptococcus (EOGBS) disease in neonates of mothers with negative antenatal screening. Maternal age <18 years and black race were the strongest predictors of EOGBS. Further research investigating contributors to the discordance between screening results and neonatal outcomes in these populations is needed.

Metronidazole Metabolism in Neonates and the Interplay Between Ontogeny and Genetic Variation

Posted on by Kayla Korzekwinski

The Journal of Clinical Pharmacology • February 2017

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Wang LA, Gonzalez D, Leeder JS, Tyndale RF, Pearce RE, Benjamin DK Jr, Kearns GL, Cohen-Wolkowiez M; Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee.

Metronidazole is commonly used to treat intra-abdominal infections in neonates. The parent drug is converted to 5 metabolites, with 2-hydroxy-metronidazole being the most clinically significant, as it possesses 30–65% of the antimicrobial activity of the parent compound. In vitro studies have demonstrated that cytochrome P450 2A6 (CYP2A6) is the primary catalyst responsible for metronidazole hydroxylation. This enzyme is initially expressed at low levels at birth, with expression increasing over the course of the first year of life to reach adult levels. CYP2A6 is known to be a highly polymorphic gene with more than 45 variant alleles that result in inactive to ultra-rapid metabolizer phenotypes. Additionally, certain allelic variants such as CYP2A6*17 have amino acid changes that alter metabolism for some but not other substrates, resulting in different metabolizing phenotypes for the same genotype. The role of genetic variation on variable metronidazole metabolism in neonates has not been previously described, nor has the effect of CYP2A6*17 on metronidazole been characterized. As such, the objective of this study was to evaluate the effect of CYP2A6 genetic variation on the pharmacokinetics of metronidazole in a small cohort of preterm neonates.

Safety of Enalapril in Infants Admitted to the Neonatal Intensive Care Unit

Posted on by Kayla Korzekwinski

Pediatric Cardiology • January 2017

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Ku LC, Zimmerman K, Benjamin DK, Clark RH, Hornik CP, Smith PB; Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee.

Enalapril is used to treat hypertension and congestive heart failure in infants. However, enalapril is not labeled for neonates, and safety data in infants are sparse. To evaluate the safety of enalapril in young infants, we conducted a retrospective cohort study of infants who were exposed to enalapril in the first 120 days of life and were cared for in 348 neonatal intensive care units from 1997 to 2012.

Use of Reflux Medications in Premature Infants After Hospital Discharge

Posted on by Kayla Korzekwinski

Pediatrics • December 2016

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Smith PB

Medications are frequently used to treat gastroesophageal reflux (GER) in premature infants. However, diagnostic modalities for GER are poor and clinical diagnosis is highly variable. Despite the frequent use of GER medications in premature infants, short- or long-term benefits of GER medications in this population are undocumented. Studies in premature infants have failed to show a correlation between apnea, bradycardia, or respiratory symptoms typically thought to be due to GER. This study sought to fill these information gaps.

Population Pharmacokinetics of Fluconazole in Premature Infants with Birth Weights Less than 750 Grams

Posted on by Kayla Korzekwinski

Antimicrobial Agents and Chemotherapy • August 2016

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Momper JD, Capparelli EV, Wade KC, Kantak A, Dhanireddy R, Cummings JJ, Nedrelow JH, Hudak ML, Mundakel GT, Natarajan G, Gao J, Laughon M, Smith PB, Benjamin DK Jr.

Fluconazole is an effective agent for prophylaxis of invasive candidiasis in premature infants. The objective of this study was to characterize the population pharmacokinetics (PK) and dosing requirements of fluconazole in infants with birth weights of <750 g. As part of a randomized clinical trial, infants born at <750 g birth weight received intravenous (i.v.) or oral fluconazole at 6 mg/kg of body weight twice weekly.

Fluconazole Prophylaxis for the Prevention of Candidiasis in Premature Infants: A Meta-analysis Using Patient-level Data

Posted on by Kayla Korzekwinski

Clinical Infectious Diseases • August 2016

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Ericson JE, Kaufman DA, Kicklighter SD, Bhatia J, Testoni D, Gao J, Smith PB, Prather KO, Benjamin DK Jr; Fluconazole Prophylaxis Study Team on behalf of the Best Pharmaceuticals for Children Act–Pediatric Trials Network Steering Committee.

Invasive candidiasis (IC) is an important cause of sepsis in premature infants and is associated with a high risk of death and neurodevelopmental impairment. Prevention of IC has become a major focus in very low birth weight infants, with fluconazole increasingly used as prophylaxis. We identified all randomized, placebo-controlled trials evaluating fluconazole prophylaxis in premature infants conducted in the United States.

Electronic Health Records and Pharmacokinetic Modeling to Assess the Relationship between Ampicillin Exposure and Seizure Risk in Neonates

Posted on by Kayla Korzekwinski

Journal of Pediatrics • August 2016

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Hornik CP, Benjamin DK Jr, Smith PB, Pencina MJ, Tremoulet AH, Capparelli EV, Ericson JE, Clark RH, Cohen-Wolkowiez M; Best Pharmaceuticals for Children Act—Pediatric Trials Network.

This was a retrospective observational cohort study of electronic health record (EHR) data combined with pharmacokinetic model derived drug exposure predictions. We used the EHR from 348 Pediatrix Medical Group neonatal intensive care units from 1997 to 2012. We included all infants 24-41 weeks gestational age, 500-5400 g birth weight, first exposed to ampicillin prior to 25 days postnatal age. In this cohort of hospitalized infants, higher ampicillin exposure was associated with seizures as documented in the EHR.