Study Population

Hospital-acquired Pneumonia and Ventilator-associated Pneumonia in Children: A Prospective Natural History and Case-Control Study

Posted on by Kayla Korzekwinski

Pediatric Infectious Disease Journal • August 2020

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Ericson JE, McGuire J, Michaels MG, Schwarz A, Frenck R, Deville JG, Agarwal S, Bressler AM, Gao J, Spears T, Benjamin DK, Smith PB, Bradley, JS

We examined laboratory and clinical features that might improve pediatric hospital-acquired and ventilator-associated bacterial pneumonias (HABP/VABP) trial efficiency by identifying risk factors predisposing children to HABP/VABP and describing the epidemiology of pediatric HABP/VABP. Food and Drug Administration-defined HABP/VABP occurred in 10%-12% of pediatric patients admitted to ICUs. Risk factors vary by age group.

Probiotic Use and Safety in the Neonatal Intensive Care Unit: A Matched Cohort Study

Posted on by Kayla Korzekwinski

Journal of Pediatrics • July 2020

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Gray KD, Messina JA, Cortina C, Owens T, Fowler M, Foster M, Gbadegesin S, Clark RH, Benjamin DK, Zimmerman KO, Greenberg RG

This study sought to determine the prevalence of probiotic administration in infants born preterm over time, as well as the association between probiotic administration and select adverse outcomes. Probiotic use increased over the study period and varied among neonatal intensive care units. Probiotic administration was associated with a decrease in NEC and death, and an increase in Candida infection, but no increase in bloodstream infection or meningitis.

Authors’ response to thrombocytopenia following exchange transfusion in neonates

Posted on by Kayla Korzekwinski

Journal of Perinatology • July 2020

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Wolf MF, Childers J, Gray KD, Chivily C, Glenn M, Jones L, Kpa M, McMannen T, Reyes I, Zimmerman KO, Clark RH, Greenberg RG

A letter from the author in response to comment on “Exchange transfusion safety and outcomes in neonatal hyperbilirubinemia.”

CYP2B6 Genotype Affects Methadone Disposition in Children as Demonstrated by Physiologically-Based Pharmacokinetic (PBPK) Modeling

Posted on by Kayla Korzekwinski

Clinical Pharmacology and Therapeutics • March 2020

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Gerhart JG, Edginton A, Watt KM, Cohen-Wolkowiez M, Harper B, Muller W, Delmore P, Atz A, Gonzalez D; on behalf of the Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee

Meeting abstract from Annual Meeting of the American-Society-for-Clinical-Pharmacology-and-Therapeutics on March 18-21, 2020.

Systemic Timolol Exposure Following Topical Application to Infantile Hemangiomas (research letter)

Posted on by Kayla Korzekwinski

Journal of the American Academy of Dermatology • March 2020

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Drolet BA, Boakye-Agyeman F, Harper B, Holland K, Lewandowski A, Stefanko N, Melloni C

Off-label ophthalmic timolol has been rapidly adopted for treatment of infantile hemangioma since topical application of β-blockers was presumed to have an improved safety profile compared with that of oral administration. We examined timolol plasma concentrations in children receiving ophthalmic preparations applied to skin hemangiomas. Timolol was detected in 86 of 92 plasma samples (93%). We predicted that young infants would have higher plasma concentrations but found that older infants (6-12 months) had the highest concentrations. Subsequently, we analyzed the effect of hemangioma size and thickness on plasma concentrations. Only hemangioma thickness significantly predicted plasma concentrations.

Medications and In-hospital Outcomes in Infants Born at 22-24 Weeks Gestation

Posted on by Kayla Korzekwinski

Journal of Perinatology • February 2020

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Puia-Dumitrescu M, Younge N, Benjamin DK, Lawson K, Hume C, Hill K, Mengistu J, Wilson A, Zimmerman ZO, Ahmad K, Greenberg RG; on behalf of the Best Pharmaceuticals for Children Act – Pediatric Trials Network

This study evaluated the most commonly used medications and in-hospital morbidities and mortality in infants born 22-24 weeks of gestation. It was a multicenter retrospective cohort study of infants born 22-24 weeks of gestation, from 2006-2016, without major congenital anomalies and with available medication data obtained from neonatal intensive care units managed by the Pediatrix Medical Group. A large number of medications were used in periviable infants. There was a high prevalence of in-hospital morbidities, and survival of this population increased over the study period.

Impact of Gastrostomy Tube Placement on Short-Term Weight Gain in Hospitalized Premature Infants

Posted on by Kayla Korzekwinski

Journal of Parenteral and Enteral Nutrition • February 2020

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Puia-Dumitrescu M, Benjamin DK Sr, Smith PB, Greenberg RG, Abuzaid N, Andrews W, Chellani K, Gupta A, Price D, Williams C, Malcolm WF, Clark RH, Zimmerman KO

Gastrostomy tube (G-tube) placement is a long-term alternative to oral or nasogastric feeding for premature infants who cannot safely feed orally or need supplemental nutrition for growth. We compared daily weight changes for G-tube infants 14 and 30 days preplacement and postplacement, excluding the first 7 days post-G-tube insertion. We also estimated a treatment effect model in which infants with a G-tube were matched 1:1 to untreated controls based on propensity scores; main outcome was the average treatment effect (weight gain) for treated infants during the 7, 14, or 30 days immediately prior to discharge.

Validation and human factor analysis study of an infant weight estimation device

Posted on by Kayla Korzekwinski

BMC Pediatrics • January 2020

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Abdel-Rahman SM, Paul IM, Delmore P, Chen JY, Mills M, Greenberg RG, on behalf of the Best Pharmaceuticals for Children Act – Pediatric Trials Network

Weight is critical for the medical management of infants; however, scales can be unavailable or inaccessible in some practice settings. We recently developed and validated a robust infant weight estimation method based on chest circumference (CC) and head circumference (HC). Among 486 infants enrolled, predicted weight was within 10 and 15% of actual weight in 86 and 99%, of infants. This device can be used to estimate weight in infants when calibrated scales are impractical or unavailable.

Population pharmacokinetics of sildenafil in extremely premature infants

Posted on by Kayla Korzekwinski

British Journal of Clinical Pharmacology • December 2019

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Gonzalez D, Laughon MM, Smith PB, Ge S, Ambalavanan N, Atz A, Sokol GM, Hornik CD, Stewart D, Mundakel G, Poindexter BB, Gaedigk R, Mills M, Cohen-Wolkowiez M, Martz K, Hornik CP

We performed a multicentre, open-label trial to characterize the pharmacokinetics (PK) of sildenafil in infants ≤28 weeks gestation and < 365 postnatal days (cohort 1) or < 32 weeks gestation and 3-42 postnatal days (cohort 2). We successfully characterized the PK of sildenafil and DMS in premature infants and applied the model to inform dosing for a follow-up, phase II study.

Dosing of Continuous Fentanyl Infusions in Obese Children: A Population Pharmacokinetic Analysis

Posted on by Kayla Korzekwinski

The Journal of Clinical Pharmacology • December 2019

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Maharaj AR, Wu H, Zimmerman KO, Speicher D, Sullivan JE, Watt K, Al-Uzri A, Payne E, Erinjeri J, Lin S, Harper B, Melloni C, Hornik CP; on behalf of the Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee
The impact of childhood obesity on fentanyl PK is relatively unknown. We developed a population pharmacokinetic (PopPK) model using opportunistically collected samples from a cohort of predominately obese children receiving fentanyl per the standard of care. Use of an allometric relationship between weight and clearance was appropriate for describing the PK of intravenous fentanyl in our cohort. Our proposed model-derived continuous infusion strategy maximized the probability of achieving target steady-state concentrations in children of varying weights.