Study Population

An anthropometric survey of US pre-term and full-term neonates

Posted on by Kayla Korzekwinski

Annals of Human Biology • December 2017

Access article on PubMed.

Abdel-Rahman SM, Paul IM, Delmore P, James L, Fearn L, Atz AM, Poindexter BB, Al-Uzri A, Lewandowski A, Harper BL, Smith PB; Best Pharmaceuticals for Children Act – Pediatric Trials Network.

Anthropometric data prove valuable for screening and monitoring various medical conditions. In young infants, however, only weight, length and head circumference are represented in publicly accessible databases. Our aim was to characterise length and circumferential measures in pre-term and full-term infants up to 90 days post-natal.

Association between early echocardiography, therapy for patent ductus arteriosus, and outcomes in very low birth weight infants

Posted on by Kayla Korzekwinski

Cardiology in the Young • November 2017

Access article on PubMed.

Lee JH, Greenberg RG, Quek BH, Clark RH, Laughon MM, Smith PB, Hornik CP

In very low birth weight infants, persistence of a patent ductus arteriosus results in morbidity and mortality. Therapies to close the ductus are effective, but clinical outcomes may depend on the accuracy of diagnosis and the timing of administration. The objective of the present study was to characterise the association between early echocardiography, therapy for patent ductus arteriosus, and outcomes in very low birth weight infants.

Population Pharmacokinetics of Dexmedetomidine in Infants

Posted on by Kayla Korzekwinski

Journal of Clinical Pharmacology • September 2017

Access article on PubMed.

Greenberg RG, Wu H, Laughon M, Capparelli E, Rowe S, Zimmerman KO, Smith PB, Cohen-Wolkowiez M

Despite limited pharmacokinetic (PK) data, dexmedetomidine is increasingly being used off-label for sedation in infants. This study aimed to characterize the developmental PK changes of dexmedetomidine during infancy.

Use of Population Pharmacokinetics and Electronic Health Records to Assess Piperacillin-Tazobactam Safety in Infants

Posted on by Kayla Korzekwinski

The Pediatric Infectious Disease Journal • September 2017

Access article on PubMed.

Salerno S, Hornik CP, Cohen-Wolkowiez M, Smith PB, Ku LC, Kelly MS, Clark R, Gonzalez D; Best Pharmaceuticals for Children Act–Pediatric Trials Network Steering Committee.

Piperacillin, in combination with tazobactam, is frequently used in infants for treating nosocomial infections, although safety data in this population are limited. Electronic health record (EHR) data can be used to evaluate drug safety in infants, but measures of drug exposure are lacking. To relate simulated piperacillin exposure with adverse events (AEs) in infants using EHR data, we identified infants discharged from 333 neonatal intensive care units managed by the Pediatrix Medical Group between 1997 and 2012.

Population Pharmacokinetics and Exploratory Pharmacodynamics of Lorazepam in Pediatric Status Epilepticus

Posted on by Kayla Korzekwinski

Clinical Pharmacokinetics • August 2017

Access article on PubMed.

Gonzalez D, Chamberlain JM, Guptill JT, Cohen-Wolkowiez M, Harper B, Zhao J, Capparelli EV; Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee.

Lorazepam is one of the preferred agents used for intravenous treatment of status epilepticus (SE). We combined data from two pediatric clinical trials to characterize the population pharmacokinetics of intravenous lorazepam in infants and children aged 3 months to 17 years with active SE or a history of SE.

Late-onset Sepsis in Extremely Premature Infants: 2000-2011

Posted on by Kayla Korzekwinski

The Pediatric Infectious Disease Journal • August 2017

Access article on PubMed.

Greenberg RG, Kandefer S, Do BT, Smith PB, Stoll BJ, Walsh MC, Bell EF, Carlo WA, Laptook AR, Sánchez PJ, Shankaran S, Van Meurs KP, Ball MB, Hale EC, Newman NS, Das A, Higgins RD, Cotton CM, for the Eunice Kennedy Shriver National Institute of Child Health

Late-onset sepsis (LOS) is an important cause of death and neurodevelopmental impairment in premature infants. The purpose of this study was to assess overall incidence of LOS, distribution of LOS-causative organisms and center variation in incidence of LOS for extremely premature infants over time.

In-hospital outcomes of premature infants with severe bronchopulmonary dysplasia

Posted on by Kayla Korzekwinski

Journal of Perinatology • July 2017

Access article on PubMed.

Jackson W, Hornik CP, Messina J, Guglielmo K, Watwe A, Delancy G, Valdez A, MacAuthur T, Peter-Wohl S, Smith PB, Clark R, Laughon MM

This study characterized in-hospital outcomes of premature infants diagnosed with severe bronchopulmonary dysplasia (BPD). A majority of infants diagnosed with severe BPD were discharged home by 44 weeks of postmenstrual age. These results may inform discussions with families regarding the expected hospital course of infants diagnosed with severe BPD.

Timing of Multiorgan Dysfunction among Hospitalized Infants with Fatal Fulminant Sepsis

Posted on by Kayla Korzekwinski

American Journal of Perinatology • June 2017

Access article on PubMed.

Wynn JL, Kelly MS, Benjamin DK, Clark RH, Greenberg R, Benjamin DK Jr, Smith PB

This study sought to identify the progression of specific signs of multiorgan dysfunction among infants with fatal sepsis. Hospitalized infants with fatal LOS manifest respiratory, cardiovascular, renal, immune, and hematologic dysfunction. Knowledge of these factors and their timing may be important for the development and testing of novel therapeutics to reduce sepsis mortality.

Risk Factors and In-Hospital Outcomes Following Tracheostomy in Infants

Posted on by Kayla Korzekwinski

The Journal of Pediatrics • June 2017

Access article on PubMed.

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

Access article on PubMed.

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.