Search

Your search keyword '"Zecic, Alexandra"' showing total 44 results
Start Over Author "Zecic, Alexandra"
44 results on '"Zecic, Alexandra"'

2. Association between seizures and neurodevelopmental outcome at two- and five years in asphyxiated newborns with therapeutic hypothermia

Author

Langeslag, J.F., primary, Onland, W., additional, Groenendaal, F., additional, de Vries, L.S., additional, van Kaam, A.H., additional, de Haan, T.R., additional, van den Akker, Chris H.P., additional, de Boode, Willem P., additional, Cools, Filip, additional, ter Horst, Henk J., additional, Dijkman, Koen P., additional, Groenendaal, Floris, additional, de Haan, Timo R., additional, Simons, Sinno H.P., additional, Steggerda, Sylke J., additional, Mulder-Tollenaer, Suzanne, additional, and Zecic, Alexandra, additional

Published
2024
Full Text
View/download PDF

4. Expectant Management or Early Ibuprofen for Patent Ductus Arteriosus

Author

Hundscheid, Tim, primary, Onland, Wes, additional, Kooi, Elisabeth M.W., additional, Vijlbrief, Daniel C., additional, de Vries, Willem B., additional, Dijkman, Koen P., additional, van Kaam, Anton H., additional, Villamor, Eduardo, additional, Kroon, André A., additional, Visser, Remco, additional, Mulder-de Tollenaer, Susanne M., additional, De Bisschop, Barbara, additional, Dijk, Peter H., additional, Avino, Daniela, additional, Hocq, Catheline, additional, Zecic, Alexandra, additional, Meeus, Marisse, additional, de Baat, Tessa, additional, Derriks, Frank, additional, Henriksen, Tine B., additional, Kyng, Kasper J., additional, Donders, Rogier, additional, Nuytemans, Debbie H.G.M., additional, Van Overmeire, Bart, additional, Mulder, Antonius L., additional, and de Boode, Willem P., additional

Published
2023
Full Text
View/download PDF

5. Early treatment versus expectative management of patent ductus arteriosus in preterm infants: a multicentre, randomised, non-inferiority trial in Europe (BeNeDuctus trial)

Author

Hundscheid, Tim, Onland, Wes, van Overmeire, Bart, Dijk, Peter, van Kaam, Anton H. L. C., Dijkman, Koen P., Kooi, Elisabeth M. W., Villamor, Eduardo, Kroon, André A., Visser, Remco, Vijlbrief, Daniel C., de Tollenaer, Susanne M., Cools, Filip, van Laere, David, Johansson, Anne-Britt, Hocq, Catheline, Zecic, Alexandra, Adang, Eddy, Donders, Rogier, de Vries, Willem, van Heijst, Arno F. J., and de Boode, Willem P.

Published
2018
Full Text
View/download PDF

10. Multi-centre, randomised non-inferiority trial of early treatment versus expectant management of patent ductus arteriosus in preterm infants (the BeNeDuctus trial): statistical analysis plan

Author

Hundscheid, Tim, Donders, Rogier, Onland, Wes, Kooi, Elisabeth M. W., Vijlbrief, Daniel C., de Vries, Willem B., Nuytemans, Debbie, Van Overmeire, Bart, Mulder, Antonius L., de Boode, Willem-Pieter, Dijk, Peter H., van Kaam, Anton H. L. C., de Baat, Tessa, Dijkman, Koen P., Villamor, Eduardo, Kroon, Andrea, Visser, Remco, de Tollenaer, Susanne Mulder, Cools, Filip, Meeus, Marisse, Johansson, Anne Britt, Derriks, Frank, Hocq, Catheline, Zecic, Alexandra, Henriksen, Tine Brink, Kyng, Kasper Jacobsen, Hundscheid, Tim, Donders, Rogier, Onland, Wes, Kooi, Elisabeth M. W., Vijlbrief, Daniel C., de Vries, Willem B., Nuytemans, Debbie, Van Overmeire, Bart, Mulder, Antonius L., de Boode, Willem-Pieter, Dijk, Peter H., van Kaam, Anton H. L. C., de Baat, Tessa, Dijkman, Koen P., Villamor, Eduardo, Kroon, Andrea, Visser, Remco, de Tollenaer, Susanne Mulder, Cools, Filip, Meeus, Marisse, Johansson, Anne Britt, Derriks, Frank, Hocq, Catheline, Zecic, Alexandra, Henriksen, Tine Brink, and Kyng, Kasper Jacobsen

Abstract

Background Controversy exists about the optimal management of a patent ductus arteriosus (PDA) in preterm infants. A persistent PDA is associated with neonatal mortality and morbidity, but causality remains unproven. Although both pharmacological and/or surgical treatment are effective in PDA closure, this has not resulted in an improved neonatal outcome. In most preterm infants, a PDA will eventually close spontaneously, hence PDA treatment potentially increases the risk of iatrogenic adverse effects. Therefore, expectant management is gaining interest, even in the absence of convincing evidence to support this strategy. Methods/design The BeNeDuctus trial is a multicentre, randomised, non-inferiority trial assessing early pharmacological treatment (24–72 h postnatal age) with ibuprofen versus expectant management of PDA in preterm infants in Europe. Preterm infants with a gestational age of less than 28 weeks and an echocardiographic-confirmed PDA with a transductal diameter of > 1.5 mm are randomly allocated to early pharmacological treatment with ibuprofen or expectant management after parental informed consent. The primary outcome measure is the composite outcome of mortality, and/or necrotizing enterocolitis Bell stage ≥ IIa, and/or bronchopulmonary dysplasia, all established at a postmenstrual age of 36 weeks. Secondary short-term outcomes are comorbidity and adverse events assessed during hospitalization and long-term neurodevelopmental outcome assessed at a corrected age of 2 years. This statistical analysis plan focusses on the short-term outcome and is written and submitted without knowledge of the data. Trial registration ClinicalTrials.gov NTR5479. Registered on October 19, 2015, with the Dutch Trial Registry, sponsored by the United States National Library of Medicine Clinicaltrials.gov NCT02884219 (registered May 2016) and the European Clinical Trials Database EudraCT 2017-001376-28., info:eu-repo/semantics/published

Published
2021

11. Intraparenchymal hemorrhage after serial ventricular reservoir taps in neonates with hydrocephalus and association with neurodevelopmental outcome at 2 years of age

Author

MS Neonatologie, Child Health, Brain, Regenerative Medicine and Stem Cells, Neurochirurgen, Cizmeci, Mehmet N., de Vries, Linda S., Tataranno, Maria Luisa, Zecic, Alexandra, van de Pol, Laura A., Alarcon, Ana, Groenendaal, Floris, Woerdeman, Peter A., MS Neonatologie, Child Health, Brain, Regenerative Medicine and Stem Cells, Neurochirurgen, Cizmeci, Mehmet N., de Vries, Linda S., Tataranno, Maria Luisa, Zecic, Alexandra, van de Pol, Laura A., Alarcon, Ana, Groenendaal, Floris, and Woerdeman, Peter A.

Published
2021

16. Phenobarbital, Midazolam Pharmacokinetics, Effectiveness, and Drug-Drug Interaction in Asphyxiated Neonates Undergoing Therapeutic Hypothermia

Author

on behalf of the PharmaCool study group, Favié, Laurent M A, Groenendaal, Floris, van den Broek, Marcel P H, Rademaker, Carin M A, de Haan, Timo R, van Straaten, Henrica L M, Dijk, Peter H, van Heijst, Arno, Simons, Sinno H P, Dijkman, Koen P, Rijken, Monique, Zonnenberg, Inge A, Cools, Filip, Zecic, Alexandra, van der Lee, Johanna H, Nuytemans, Debbie H G M, van Bel, Frank, Egberts, Toine C G, Huitema, Alwin D R, on behalf of the PharmaCool study group, Favié, Laurent M A, Groenendaal, Floris, van den Broek, Marcel P H, Rademaker, Carin M A, de Haan, Timo R, van Straaten, Henrica L M, Dijk, Peter H, van Heijst, Arno, Simons, Sinno H P, Dijkman, Koen P, Rijken, Monique, Zonnenberg, Inge A, Cools, Filip, Zecic, Alexandra, van der Lee, Johanna H, Nuytemans, Debbie H G M, van Bel, Frank, Egberts, Toine C G, and Huitema, Alwin D R

Abstract

BACKGROUND: Phenobarbital and midazolam are commonly used drugs in (near-)term neonates treated with therapeutic hypothermia for hypoxic-ischaemic encephalopathy, for sedation, and/or as anti-epileptic drug. Phenobarbital is an inducer of cytochrome P450 (CYP) 3A, while midazolam is a CYP3A substrate. Therefore, co-treatment with phenobarbital might impact midazolam clearance.OBJECTIVES: To assess pharmacokinetics and clinical anti-epileptic effectiveness of phenobarbital and midazolam in asphyxiated neonates and to develop dosing guidelines.METHODS: Data were collected in the prospective multicentre PharmaCool study. In the present study, neonates treated with therapeutic hypothermia and receiving midazolam and/or phenobarbital were included. Plasma concentrations of phenobarbital and midazolam including its metabolites were determined in blood samples drawn on days 2-5 after birth. Pharmacokinetic analyses were performed using non-linear mixed effects modelling; clinical effectiveness was defined as no use of additional anti-epileptic drugs.RESULTS: Data were available from 113 (phenobarbital) and 118 (midazolam) neonates; 68 were treated with both medications. Only clearance of 1-hydroxy midazolam was influenced by hypothermia. Phenobarbital co-administration increased midazolam clearance by a factor 2.3 (95% CI 1.9-2.9, p < 0.05). Anticonvulsant effectiveness was 65.5% for phenobarbital and 37.1% for add-on midazolam.CONCLUSIONS: Therapeutic hypothermia does not influence clearance of phenobarbital or midazolam in (near-)term neonates with hypoxic-ischaemic encephalopathy. A phenobarbital dose of 30 mg/kg is advised to reach therapeutic concentrations. Phenobarbital co-administration significantly increased midazolam clearance. Should phenobarbital be substituted by non-CYP3A inducers as first-line anticonvulsant, a 50% lower midazolam maintenance dose might be appropriate to avoid excessive exposure during the first days after

Published
2019

17. Phenobarbital, Midazolam Pharmacokinetics, Effectiveness, and Drug-Drug Interaction in Asphyxiated Neonates Undergoing Therapeutic Hypothermia

Author

Favié, Laurent M.A., Groenendaal, Floris, Van Den Broek, Marcel P.H., Rademaker, Carin M.A., De Haan, Timo R., Van Straaten, Henrica L.M., Dijk, Peter H., Van Heijst, Arno, Simons, Sinno H.P., Dijkman, Koen P., Rijken, Monique, Zonnenberg, Inge A., Cools, Filip, Zecic, Alexandra, Van Der Lee, Johanna H., Nuytemans, Debbie H.G.M., Van Bel, Frank, Egberts, Toine C.G., Huitema, Alwin D.R., Favié, Laurent M.A., Groenendaal, Floris, Van Den Broek, Marcel P.H., Rademaker, Carin M.A., De Haan, Timo R., Van Straaten, Henrica L.M., Dijk, Peter H., Van Heijst, Arno, Simons, Sinno H.P., Dijkman, Koen P., Rijken, Monique, Zonnenberg, Inge A., Cools, Filip, Zecic, Alexandra, Van Der Lee, Johanna H., Nuytemans, Debbie H.G.M., Van Bel, Frank, Egberts, Toine C.G., and Huitema, Alwin D.R.

Published
2019

18. Pharmacokinetics of morphine in encephalopathic neonates treated with therapeutic hypothermia

Author

Favié, Laurent M.A., Groenendaal, Floris, van den Broek, Marcel P.H., Rademaker, Carin M.A., De Haan, Timo R., Van Straaten, Henrica L.M., Dijk, Peter H., Van Heijst, Arno, Dudink, Jeroen, Dijkman, Koen P., Rijken, Monique, Zonnenberg, Inge A., Cools, Filip, Zecic, Alexandra, van der Lee, Johanna H., Nuytemans, Debbie H.G.M., van Bel, Frank, Egberts, Toine C.G., Huitema, Alwin D.R., the PharmaCool study group, Favié, Laurent M.A., Groenendaal, Floris, van den Broek, Marcel P.H., Rademaker, Carin M.A., De Haan, Timo R., Van Straaten, Henrica L.M., Dijk, Peter H., Van Heijst, Arno, Dudink, Jeroen, Dijkman, Koen P., Rijken, Monique, Zonnenberg, Inge A., Cools, Filip, Zecic, Alexandra, van der Lee, Johanna H., Nuytemans, Debbie H.G.M., van Bel, Frank, Egberts, Toine C.G., Huitema, Alwin D.R., and the PharmaCool study group

Published
2019

19. Pharmacokinetics of morphine in encephalopathic neonates treated with therapeutic hypothermia

Author

Pharmacoepidemiology and Clinical Pharmacology, Afd Pharmacoepi & Clinical Pharmacology, PharmaCool study group, Favié, Laurent M A, Groenendaal, Floris, van den Broek, Marcel P H, Rademaker, Carin M A, de Haan, Timo R, van Straaten, Henrica L M, Dijk, Peter H, van Heijst, Arno, Dudink, Jeroen, Dijkman, Koen P, Rijken, Monique, Zonnenberg, Inge A, Cools, Filip, Zecic, Alexandra, van der Lee, Johanna H, Nuytemans, Debbie H G M, van Bel, Frank, Egberts, Toine C G, Huitema, Alwin D R, Pharmacoepidemiology and Clinical Pharmacology, Afd Pharmacoepi & Clinical Pharmacology, PharmaCool study group, Favié, Laurent M A, Groenendaal, Floris, van den Broek, Marcel P H, Rademaker, Carin M A, de Haan, Timo R, van Straaten, Henrica L M, Dijk, Peter H, van Heijst, Arno, Dudink, Jeroen, Dijkman, Koen P, Rijken, Monique, Zonnenberg, Inge A, Cools, Filip, Zecic, Alexandra, van der Lee, Johanna H, Nuytemans, Debbie H G M, van Bel, Frank, Egberts, Toine C G, and Huitema, Alwin D R

Published
2019

20. Phenobarbital, Midazolam Pharmacokinetics, Effectiveness, and Drug-Drug Interaction in Asphyxiated Neonates Undergoing Therapeutic Hypothermia

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, on behalf of the PharmaCool study group, Favié, Laurent M A, Groenendaal, Floris, van den Broek, Marcel P H, Rademaker, Carin M A, de Haan, Timo R, van Straaten, Henrica L M, Dijk, Peter H, van Heijst, Arno, Simons, Sinno H P, Dijkman, Koen P, Rijken, Monique, Zonnenberg, Inge A, Cools, Filip, Zecic, Alexandra, van der Lee, Johanna H, Nuytemans, Debbie H G M, van Bel, Frank, Egberts, Toine C G, Huitema, Alwin D R, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, on behalf of the PharmaCool study group, Favié, Laurent M A, Groenendaal, Floris, van den Broek, Marcel P H, Rademaker, Carin M A, de Haan, Timo R, van Straaten, Henrica L M, Dijk, Peter H, van Heijst, Arno, Simons, Sinno H P, Dijkman, Koen P, Rijken, Monique, Zonnenberg, Inge A, Cools, Filip, Zecic, Alexandra, van der Lee, Johanna H, Nuytemans, Debbie H G M, van Bel, Frank, Egberts, Toine C G, and Huitema, Alwin D R

Published
2019

21. Phenobarbital, Midazolam Pharmacokinetics, Effectiveness, and Drug-Drug Interaction in Asphyxiated Neonates Undergoing Therapeutic Hypothermia

Author

UMC Utrecht, Apotheek Onderzoek, Brain, Child Health, Infection & Immunity, Regenerative Medicine and Stem Cells, MS Neonatologie, Apotheek Klinische Farmacie, Apotheek Opleiding, Cancer, Favié, Laurent M.A., Groenendaal, Floris, Van Den Broek, Marcel P.H., Rademaker, Carin M.A., De Haan, Timo R., Van Straaten, Henrica L.M., Dijk, Peter H., Van Heijst, Arno, Simons, Sinno H.P., Dijkman, Koen P., Rijken, Monique, Zonnenberg, Inge A., Cools, Filip, Zecic, Alexandra, Van Der Lee, Johanna H., Nuytemans, Debbie H.G.M., Van Bel, Frank, Egberts, Toine C.G., Huitema, Alwin D.R., UMC Utrecht, Apotheek Onderzoek, Brain, Child Health, Infection & Immunity, Regenerative Medicine and Stem Cells, MS Neonatologie, Apotheek Klinische Farmacie, Apotheek Opleiding, Cancer, Favié, Laurent M.A., Groenendaal, Floris, Van Den Broek, Marcel P.H., Rademaker, Carin M.A., De Haan, Timo R., Van Straaten, Henrica L.M., Dijk, Peter H., Van Heijst, Arno, Simons, Sinno H.P., Dijkman, Koen P., Rijken, Monique, Zonnenberg, Inge A., Cools, Filip, Zecic, Alexandra, Van Der Lee, Johanna H., Nuytemans, Debbie H.G.M., Van Bel, Frank, Egberts, Toine C.G., and Huitema, Alwin D.R.

Published
2019

22. Pharmacokinetics of morphine in encephalopathic neonates treated with therapeutic hypothermia

Author

UMC Utrecht, Apotheek Opleiding, Brain, Child Health, Infection & Immunity, Regenerative Medicine and Stem Cells, MS Neonatologie, Apotheek Klinische Farmacie, Apotheek Onderzoek, Favié, Laurent M.A., Groenendaal, Floris, van den Broek, Marcel P.H., Rademaker, Carin M.A., De Haan, Timo R., Van Straaten, Henrica L.M., Dijk, Peter H., Van Heijst, Arno, Dudink, Jeroen, Dijkman, Koen P., Rijken, Monique, Zonnenberg, Inge A., Cools, Filip, Zecic, Alexandra, van der Lee, Johanna H., Nuytemans, Debbie H.G.M., van Bel, Frank, Egberts, Toine C.G., Huitema, Alwin D.R., the PharmaCool study group, UMC Utrecht, Apotheek Opleiding, Brain, Child Health, Infection & Immunity, Regenerative Medicine and Stem Cells, MS Neonatologie, Apotheek Klinische Farmacie, Apotheek Onderzoek, Favié, Laurent M.A., Groenendaal, Floris, van den Broek, Marcel P.H., Rademaker, Carin M.A., De Haan, Timo R., Van Straaten, Henrica L.M., Dijk, Peter H., Van Heijst, Arno, Dudink, Jeroen, Dijkman, Koen P., Rijken, Monique, Zonnenberg, Inge A., Cools, Filip, Zecic, Alexandra, van der Lee, Johanna H., Nuytemans, Debbie H.G.M., van Bel, Frank, Egberts, Toine C.G., Huitema, Alwin D.R., and the PharmaCool study group

Published
2019

24. Population Pharmacokinetics of Amoxicillin in Term Neonates Undergoing Moderate Hypothermia

Author

Bijleveld, Yuma A, Mathôt, Ron A A, van der Lee, Johanna H, Groenendaal, Floris, Dijk, Peter H, van Heijst, Arno, Simons, Sinno H P, Dijkman, Koen P, van Straaten, Henrica L M, Rijken, Monique, Zonnenberg, Inge A, Cools, Filip, Zecic, Alexandra, Nuytemans, Debbie H G M, van Kaam, Anton H, de Haan, Timo R, and PharmaCool study group

Subjects
Pharmacology, amoxicillin, Journal Article, Pharmacokinetics, Therapeutic hypothermia, Pharmacology (medical), neonate, perinatal asphyxia
Abstract

The pharmacokinetics (PK) of amoxicillin in asphyxiated newborns undergoing moderate hypothermia were quantified using prospective data (N = 125). The population PK was described by a 2-compartment model with a priori birthweight (BW) based allometric scaling. Significant correlations were observed between clearance (Cl) and postnatal age (PNA), gestational age (GA), body temperature (TEMP), and urine output (UO). For a typical patient with GA 40 weeks, BW 3,000 g, 2 days PNA (i.e., TEMP 33.5°C), and normal UO, Cl was 0.26 L/h (interindividual variability (IIV) 41.9%) and volume of distribution of the central compartment was 0.34 L/kg (IIV of 114.6%). For this patient, Cl increased to 0.41 L/h at PNA 5 days and TEMP 37.0°C. The respective contributions of both covariates were 23% and 27%. Based on Monte Carlo simulations we recommend 50 and 75 mg/kg/24h amoxicillin in three doses for patients with GA 36-37 and 38-42 weeks, respectively.

Published
2018

25. Early treatment versus expectative management of patent ductus arteriosus in preterm infants: a multicentre, randomised, non-inferiority trial in Europe (BeNeDuctus trial)

Author

UCL - (SLuc) Service de néonatologie, UCL - SSS/IREC/SLUC - Pôle St.-Luc, Hundscheid, Tim, Onland, Wes, van Overmeire, Bart, Dijk, Peter, van Kaam, Anton H. L. C., Dijkman, Koen P., Kooi, Elisabeth M. W., Villamor, Eduardo, Kroon, André A., Visser, Remco, Vijlbrief, Daniel C., de Tollenaer, Susanne M., Cools, Filip, van Laere, David, Johansson, Anne-Britt, Hocq, Catheline, Zecic, Alexandra, Adang, Eddy, Donders, Rogier, de Vries, Willem, van Heijst, Arno F. J., de Boode, Willem P., UCL - (SLuc) Service de néonatologie, UCL - SSS/IREC/SLUC - Pôle St.-Luc, Hundscheid, Tim, Onland, Wes, van Overmeire, Bart, Dijk, Peter, van Kaam, Anton H. L. C., Dijkman, Koen P., Kooi, Elisabeth M. W., Villamor, Eduardo, Kroon, André A., Visser, Remco, Vijlbrief, Daniel C., de Tollenaer, Susanne M., Cools, Filip, van Laere, David, Johansson, Anne-Britt, Hocq, Catheline, Zecic, Alexandra, Adang, Eddy, Donders, Rogier, de Vries, Willem, van Heijst, Arno F. J., and de Boode, Willem P.

Abstract

BACKGROUND: Much controversy exists about the optimal management of a patent ductus arteriosus (PDA) in preterm infants, especially in those born at a gestational age (GA) less than 28 weeks. No causal relationship has been proven between a (haemodynamically significant) PDA and neonatal complications related to pulmonary hyperperfusion and/or systemic hypoperfusion. Although studies show conflicting results, a common understanding is that medical or surgical treatment of a PDA does not seem to reduce the risk of major neonatal morbidities and mortality. As the PDA might have closed spontaneously, treated children are potentially exposed to iatrogenic adverse effects. A conservative approach is gaining interest worldwide, although convincing evidence to support its use is lacking. METHODS: This multicentre, randomised, non-inferiority trial is conducted in neonatal intensive care units. The study population consists of preterm infants (GA < 28 weeks) with an echocardiographic-confirmed PDA with a transductal diameter > 1.5 mm. Early treatment (between 24 and 72 h postnatal age) with the cyclooxygenase inhibitor (COXi) ibuprofen (IBU) is compared with an expectative management (no intervention intended to close a PDA). The primary outcome is the composite of mortality, and/or necrotising enterocolitis (NEC) Bell stage ≥ IIa, and/or bronchopulmonary dysplasia (BPD) defined as the need for supplemental oxygen, all at a postmenstrual age (PMA) of 36 weeks. Secondary outcome parameters are short term sequelae of cardiovascular failure, comorbidity and adverse events assessed during hospitalization and long-term neurodevelopmental outcome assessed at a corrected age of 2 years. Consequences regarding health economics are evaluated by cost effectiveness analysis and budget impact analysis. DISCUSSION: As a conservative approach is gaining interest, we investigate whether in preterm infants, born at a GA less than 28 weeks, with a PDA an expectative management is non-inferi

Published
2018

26. Early treatment versus expectative management of patent ductus arteriosus in preterm infants: A multicentre, randomised, non-inferiority trial in Europe (BeNeDuctus trial)

Author

MS Neonatologie, Child Health, Infection & Immunity, Hundscheid, Tim, Onland, Wes, van Overmeire, Bart, Dijk, Peter H., van Kaam, Anton H.L.C., Dijkman, Koen P., Kooi, Elisabeth M.W., Villamor, Eduardo, Kroon, André A., Visser, Remco, Vijlbrief, Daniel C., de Tollenaer, Susanne M., Cools, Filip, van Laere, David, Johansson, Anne Britt, Hocq, Catheline, Zecic, Alexandra, Adang, Eddy, Donders, Rogier, de Vries, Willem, van Heijst, Arno F.J., de Boode, Willem P., MS Neonatologie, Child Health, Infection & Immunity, Hundscheid, Tim, Onland, Wes, van Overmeire, Bart, Dijk, Peter H., van Kaam, Anton H.L.C., Dijkman, Koen P., Kooi, Elisabeth M.W., Villamor, Eduardo, Kroon, André A., Visser, Remco, Vijlbrief, Daniel C., de Tollenaer, Susanne M., Cools, Filip, van Laere, David, Johansson, Anne Britt, Hocq, Catheline, Zecic, Alexandra, Adang, Eddy, Donders, Rogier, de Vries, Willem, van Heijst, Arno F.J., and de Boode, Willem P.

Published
2018

27. Outcome of Infants with Therapeutic Hypothermia after Perinatal Asphyxia and Early-Onset Sepsis

Author

Hakobyan, Mariam, primary, Dijkman, Koen P., additional, Laroche, Sabrina, additional, Naulaers, Gunnar, additional, Rijken, Monique, additional, Steiner, Katerina, additional, van Straaten, Henrica L.M., additional, Swarte, Renate M.C., additional, ter Horst, Hendrik J., additional, Zecic, Alexandra, additional, Zonnenberg, Inge A., additional, and Groenendaal, Floris, additional

Published
2018
Full Text
View/download PDF

29. Evaluation of a System-Specific Function To Describe the Pharmacokinetics of Benzylpenicillin in Term Neonates Undergoing Moderate Hypothermia

Author

Bijleveld, Yuma A., primary, de Haan, Timo R., additional, van der Lee, Johanna H., additional, Groenendaal, Floris, additional, Dijk, Peter H., additional, van Heijst, Arno, additional, de Jonge, Rogier C. J., additional, Dijkman, Koen P., additional, van Straaten, Henrica L. M., additional, Rijken, Monique, additional, Zonnenberg, Inge A., additional, Cools, Filip, additional, Zecic, Alexandra, additional, Nuytemans, Debbie H. G. M., additional, van Kaam, Anton H., additional, and Mathôt, Ron A. A., additional

Published
2018
Full Text
View/download PDF

30. Phenobarbital, Midazolam Pharmacokinetics, Effectiveness, and Drug-Drug Interaction in Asphyxiated Neonates Undergoing Therapeutic Hypothermia.

Author

Favié, Laurent M.A., Groenendaal, Floris, van den Broek, Marcel P.H., Rademaker, Carin M.A., de Haan, Timo R., van Straaten, Henrica L.M., Dijk, Peter H., van Heijst, Arno, Simons, Sinno H.P., Dijkman, Koen P., Rijken, Monique, Zonnenberg, Inge A., Cools, Filip, Zecic, Alexandra, van der Lee, Johanna H., Nuytemans, Debbie H.G.M., van Bel, Frank, Egberts, Toine C.G., and Huitema, Alwin D.R.

Subjects
THERAPEUTIC hypothermia, MIDAZOLAM, NEWBORN infants, PHARMACOKINETICS, CYTOCHROME P-450, INDUCED hypothermia
Abstract

Background: Phenobarbital and midazolam are commonly used drugs in (near-)term neonates treated with therapeutic hypothermia for hypoxic-ischaemic encephalopathy, for sedation, and/or as anti-epileptic drug. Phenobarbital is an inducer of cytochrome P450 (CYP) 3A, while midazolam is a CYP3A substrate. Therefore, co-treatment with phenobarbital might impact midazolam clearance. Objectives: To assess pharmacokinetics and clinical anti-epileptic effectiveness of phenobarbital and midazolam in asphyxiated neonates and to develop dosing guidelines. Methods: Data were collected in the prospective multicentre PharmaCool study. In the present study, neonates treated with therapeutic hypothermia and receiving midazolam and/or phenobarbital were included. Plasma concentrations of phenobarbital and midazolam including its metabolites were determined in blood samples drawn on days 2–5 after birth. Pharmacokinetic analyses were performed using non-linear mixed effects modelling; clinical effectiveness was defined as no use of additional anti-epileptic drugs. Results: Data were available from 113 (phenobarbital) and 118 (midazolam) neonates; 68 were treated with both medications. Only clearance of 1-hydroxy midazolam was influenced by hypothermia. Phenobarbital co-administration increased midazolam clearance by a factor 2.3 (95% CI 1.9–2.9, p < 0.05). Anticonvulsant effectiveness was 65.5% for phenobarbital and 37.1% for add-on midazolam. Conclusions: Therapeutic hypothermia does not influence clearance of phenobarbital or midazolam in (near-)term neonates with hypoxic-ischaemic encephalopathy. A phenobarbital dose of 30 mg/kg is advised to reach therapeutic concentrations. Phenobarbital co-administration significantly increased midazolam clearance. Should phenobarbital be substituted by non-CYP3A inducers as first-line anticonvulsant, a 50% lower midazolam maintenance dose might be appropriate to avoid excessive exposure during the first days after birth. [ABSTRACT FROM AUTHOR]

Published
2019
Full Text
View/download PDF

31. Outcome of Infants with Therapeutic Hypothermia after Perinatal Asphyxia and Early-Onset Sepsis.

Author

Hakobyan, Mariam, Dijkman, Koen P., Laroche, Sabrina, Naulaers, Gunnar, Rijken, Monique, Steiner, Katerina, van Straaten, Henrica L.M., Swarte, Renate M.C., ter Horst, Hendrik J., Zecic, Alexandra, Zonnenberg, Inge A., and Groenendaal, Floris

Subjects
ASPHYXIA neonatorum, NEONATAL sepsis, THERAPEUTIC hypothermia, STREPTOCOCCUS agalactiae, SEPSIS, BIRTH weight
Abstract

Background: Animal models suggest that neuroprotective effects of therapeutic hypothermia (TH) after perinatal asphyxia are reduced in infants with early-onset sepsis. Objectives: To assess the outcome of infants with perinatal asphyxia, neonatal encephalopathy, and TH in the presence of early-onset sepsis. Methods: In a retrospective cohort of 1,084 infants with perinatal asphyxia and TH, the outcome of 42 infants (gestational age 36.1–42.6 weeks and birth weight 2,280–5,240 g) with proven sepsis (n = 14) and probable sepsis (n = 28) was analyzed. Death, cerebral palsy, or a delayed development at 2 years was considered an adverse outcome. Results: Sepsis was caused mostly by group B streptococci (n = 17), other Gram-positive bacteria (n = 5), and Candida albicans (n = 1). Of the 42 infants, 9 (21.4%) died, and 5 (11.9%) showed impairments on follow-up. The outcome is comparable to the previously reported outcome of infants with TH without early-onset sepsis. Conclusion: A good outcome was reported in the majority of infants with perinatal asphyxia, TH, and early-onset sepsis. Cooling should not be withheld from these infants. [ABSTRACT FROM AUTHOR]

Published
2019
Full Text
View/download PDF

32. Pharmacokinetics of morphine in encephalopathic neonates treated with therapeutic hypothermia.

Author

Favié, Laurent M. A., Groenendaal, Floris, van den Broek, Marcel P. H., Rademaker, Carin M. A., de Haan, Timo R., van Straaten, Henrica L. M., Dijk, Peter H., van Heijst, Arno, Dudink, Jeroen, Dijkman, Koen P., Rijken, Monique, Zonnenberg, Inge A., Cools, Filip, Zecic, Alexandra, van der Lee, Johanna H., Nuytemans, Debbie H. G. M., van Bel, Frank, Egberts, Toine C. G., Huitema, Alwin D. R., and null, null

Subjects
MORPHINE, HYPOTHERMIA, CAUSES of death, RESPIRATORY diseases, POISONOUS gases
Abstract

Objective: Morphine is a commonly used drug in encephalopathic neonates treated with therapeutic hypothermia after perinatal asphyxia. Pharmacokinetics and optimal dosing of morphine in this population are largely unknown. The objective of this study was to describe pharmacokinetics of morphine and its metabolites morphine-3-glucuronide and morphine-6-glucuronide in encephalopathic neonates treated with therapeutic hypothermia and to develop pharmacokinetics based dosing guidelines for this population. Study design: Term and near-term encephalopathic neonates treated with therapeutic hypothermia and receiving morphine were included in two multicenter cohort studies between 2008–2010 (SHIVER) and 2010–2014 (PharmaCool). Data were collected during hypothermia and rewarming, including blood samples for quantification of morphine and its metabolites. Parental informed consent was obtained for all participants. Results: 244 patients (GA mean (sd) 39.8 (1.6) weeks, BW mean (sd) 3,428 (613) g, male 61.5%) were included. Morphine clearance was reduced under hypothermia (33.5°C) by 6.89%/°C (95% CI 5.37%/°C– 8.41%/°C, p<0.001) and metabolite clearance by 4.91%/°C (95% CI 3.53%/°C– 6.22%/°C, p<0.001) compared to normothermia (36.5°C). Simulations showed that a loading dose of 50 μg/kg followed by continuous infusion of 5 μg/kg/h resulted in morphine plasma concentrations in the desired range (between 10 and 40 μg/L) during hypothermia. Conclusions: Clearance of morphine and its metabolites in neonates is affected by therapeutic hypothermia. The regimen suggested by the simulations will be sufficient in the majority of patients. However, due to the large interpatient variability a higher dose might be necessary in individual patients to achieve the desired effect. Trial registration: . [ABSTRACT FROM AUTHOR]

Published
2019
Full Text
View/download PDF

33. The Thompson Encephalopathy Score and Short-Term Outcomes in Asphyxiated Newborns Treated With Therapeutic Hypothermia

Author

Thorsen, Patricia, Jansen-van der Weide, Martine C, Groenendaal, Floris, Onland, Wes, van Straaten, Henrika L M, Zonnenberg, Inge, Vermeulen, Jeroen R., Dijk, Peter H, Dudink, Jeroen, Rijken, Monique, van Heijst, Arno, Dijkman, Koen P, Cools, Filip, Zecic, Alexandra, van Kaam, Anton H, de Haan, Timo R, Thorsen, Patricia, Jansen-van der Weide, Martine C, Groenendaal, Floris, Onland, Wes, van Straaten, Henrika L M, Zonnenberg, Inge, Vermeulen, Jeroen R., Dijk, Peter H, Dudink, Jeroen, Rijken, Monique, van Heijst, Arno, Dijkman, Koen P, Cools, Filip, Zecic, Alexandra, van Kaam, Anton H, and de Haan, Timo R

Published
2016

34. Altered gentamicin pharmacokinetics in term neonates undergoing controlled hypothermia

Author

MS Neonatologie, Child Health, Brain, Regenerative Medicine and Stem Cells, Onderzoek met verpleegkundig onderzoekers V&B, Geboortecentrum Zorg, Apotheek Klinische Farmacie, Apotheek Opleiding, Infection & Immunity, Bijleveld, Yuma A., De Haan, Timo R., Van Der Lee, Hanneke J H, Groenendaal, Floris, Dijk, Peter H., Van Heijst, Arno, De Jonge, Rogier C J, Dijkman, Koen P., Van Straaten, Henrica L M, Rijken, Monique, Zonnenberg, Inge A., Cools, Filip, Zecic, Alexandra, Nuytemans, Debbie H G M, Van Kaam, Anton H., Mathot, Ron A A, Brouwer, Mieke J., Van Den Broek, Marcel P., Rademaker, Carin M A, Liem, Djien, Steiner, Katerna, Simons, Sinno H P, Bos, Annelies A., Mulder-De Tollenaer, S. M., Groot Jebbink-Akkerman, L. J M, Sonnaert, Michel, Camfferman, Fleur Anne, MS Neonatologie, Child Health, Brain, Regenerative Medicine and Stem Cells, Onderzoek met verpleegkundig onderzoekers V&B, Geboortecentrum Zorg, Apotheek Klinische Farmacie, Apotheek Opleiding, Infection & Immunity, Bijleveld, Yuma A., De Haan, Timo R., Van Der Lee, Hanneke J H, Groenendaal, Floris, Dijk, Peter H., Van Heijst, Arno, De Jonge, Rogier C J, Dijkman, Koen P., Van Straaten, Henrica L M, Rijken, Monique, Zonnenberg, Inge A., Cools, Filip, Zecic, Alexandra, Nuytemans, Debbie H G M, Van Kaam, Anton H., Mathot, Ron A A, Brouwer, Mieke J., Van Den Broek, Marcel P., Rademaker, Carin M A, Liem, Djien, Steiner, Katerna, Simons, Sinno H P, Bos, Annelies A., Mulder-De Tollenaer, S. M., Groot Jebbink-Akkerman, L. J M, Sonnaert, Michel, and Camfferman, Fleur Anne

Published
2016

35. The Thompson Encephalopathy Score and Short-Term Outcomes in Asphyxiated Newborns Treated With Therapeutic Hypothermia

Author

MS Neonatologie, Brain, Child Health, Regenerative Medicine and Stem Cells, Thorsen, Patricia, Jansen-van der Weide, Martine C, Groenendaal, Floris, Onland, Wes, van Straaten, Henrika L M, Zonnenberg, Inge, Vermeulen, Jeroen R., Dijk, Peter H, Dudink, Jeroen, Rijken, Monique, van Heijst, Arno, Dijkman, Koen P, Cools, Filip, Zecic, Alexandra, van Kaam, Anton H, de Haan, Timo R, MS Neonatologie, Brain, Child Health, Regenerative Medicine and Stem Cells, Thorsen, Patricia, Jansen-van der Weide, Martine C, Groenendaal, Floris, Onland, Wes, van Straaten, Henrika L M, Zonnenberg, Inge, Vermeulen, Jeroen R., Dijk, Peter H, Dudink, Jeroen, Rijken, Monique, van Heijst, Arno, Dijkman, Koen P, Cools, Filip, Zecic, Alexandra, van Kaam, Anton H, and de Haan, Timo R

Published
2016

36. The Thompson Encephalopathy Score and Short-Term Outcomes in Asphyxiated Newborns Treated With Therapeutic Hypothermia

Author

Thorsen, Patricia, primary, Jansen-van der Weide, Martine C., additional, Groenendaal, Floris, additional, Onland, Wes, additional, van Straaten, Henrika L.M., additional, Zonnenberg, Inge, additional, Vermeulen, Jeroen R., additional, Dijk, Peter H., additional, Dudink, Jeroen, additional, Rijken, Monique, additional, van Heijst, Arno, additional, Dijkman, Koen P., additional, Cools, Filip, additional, Zecic, Alexandra, additional, van Kaam, Anton H., additional, and de Haan, Timo R., additional

Published
2016
Full Text
View/download PDF

37. Effect of Treatment of Subclinical Neonatal Seizures Detected With aEEG: Randomized, Controlled Trial

Author

van Rooij, Linda G. M., primary, Toet, Mona C., additional, van Huffelen, Alexander C., additional, Groenendaal, Floris, additional, Laan, Wijnand, additional, Zecic, Alexandra, additional, de Haan, Timo, additional, van Straaten, Irma L. M., additional, Vrancken, Sabine, additional, van Wezel, Gerda, additional, van der Sluijs, Jaqueline, additional, ter Horst, Henk, additional, Gavilanes, Danilo, additional, Laroche, Sabrina, additional, Naulaers, Gunnar, additional, and de Vries, Linda S., additional

Published
2010
Full Text
View/download PDF

38. Lactic Acidosis in a Newborn With Adrenal Calcifications

Author

Zecic, Alexandra, primary, Smet, Joél E, additional, Praeter, Claudine M De, additional, Vanhaesebrouck, Piet, additional, Viscomi, Carlo, additional, Broecke, Caroline Van Den, additional, Paepe, Boel De, additional, Lohse, Peter, additional, Martin, Jean-Jacques, additional, Jackson, Joshua G, additional, Campbell, Colin R, additional, Meirleir, Linda J De, additional, Zeviani, Massimo, additional, Seneca, Sara H, additional, Lissens, Willy, additional, and Coster, Rudy N Van, additional

Published
2009
Full Text
View/download PDF

40. Phototherapy-mediated syndrome of inappropriate secretion of antidiuretic hormone in an in utero selective serotonin reuptake inhibitor-exposed newborn infant

Author

Vanhaesebrouck, Piet, De Bock, Freia, Zecic, Alexandra, De Praeter, Claudine, Smets, Koenraad, De Coen, Kris, and Goossens, Linde

Subjects
Phototherapy -- Research, Serotonin uptake inhibitors -- Research, Vasopressin -- Research
Abstract

Although selective serotonin reuptake inhibitors (SSRIs) have gained wide acceptance in the off-label treatment of mental disorders in pregnant women, there seems to be an increased risk for serotonergic adverse effects in newborn infants who are exposed to SSRIs during late pregnancy. Hyponatremia as a result of the syndrome of inappropriate secretion of antidiuretic hormone (SIADH) is a relatively common serious side effect of the use of SSRIs in (mostly elderly) adults. Severe hyponatremia as a result of an SIADH is proposed here as part of a neonatal serotonin toxicity syndrome in a newborn infant who was exposed prenatally to an SSRI. The definite reversal to normal serum sodium levels after fluid restriction, the lack of any alternative cause for the SIADH, and the positive temporal relation with a high score on a widely used adverse drug reaction probability scale offer solid support for the hypothesis of a causal relationship between the SIADH and the prenatal sertraline exposure in our neonate. Moreover, accumulative data on the acute enhancement of serotonergic transmission by intense illumination led us to hypothesize that phototherapy used to treat hyperbilirubinemia in the newborn infant could have been the ultimate environmental trigger for this proposed new cause of iatrogenic neonatal SIADH. The speculative role of phototherapy as a physical trigger for this drug-related adverse event should be confirmed in other cases by thorough study of the serotonin metabolism, assay of SSRI levels in cord blood, and serial measurement of plasma levels in exposed neonates. As phototherapy is used frequently in jaundiced neonates and an apparently increasing number of infants are born to mothers who take SSRIs, serotonin toxicity in neonates deserves increased attention. URL: www.pediatrics.org/cgi/doi/10.1542/peds.2004-2329; neonate, hyponatremia, selective serotonin reuptake inhibitor, syndrome of inappropriate secretion of antidiuretic hormone, serotonin syndrome, phototherapy.

Published
2005

43. Introduction of Hypothermia for Neonates with Perinatal Asphyxia in the Netherlands and Flanders.

Author

Groenendaal, Floris, Casaer, alexandra, Dijkman, Koen P., Gavilanes, antonio W.D., de Haan, Timo R., ter Horst, Henk J., Laroche, Sabine, Naulaers, Gunnar, Rijken, Monique, van Straaten, Henrica L.M., Steiner, Katerina, Swarte, Renate M.C., Zecic, alexandra, and Zonnenberg, Inge a.

Subjects
HYPOTHERMIA, ASPHYXIA neonatorum, HUMAN abnormalities, METABOLIC disorders, MORTALITY, CEREBRAL palsy
Abstract

Background: Therapeutic hypothermia was introduced in the Netherlands and Flanders, Belgium, in 2008. Since then, an increasing number of patients has been treated - up to 166 in 2010. Complications and outcome were registered in an online database. Objectives: The aim of this study was to analyse complications and outcome after implementation. Methods: Data were retrieved from an online database to which all centres had contributed. Results: In 3 years, 332 patients were treated. Excluding 24 patients with congenital abnormalities or metabolic disorders, mortality was 31.8%. Of the 210 survivors without congenital malformations, 21 had cerebral palsy, another 19 a developmental delay of more than 3 months at the age of at least 24 months, and 2 had severe hearing loss. The total adverse outcome, combining death and adverse neurodevelopment, in 308 patients without congenital malformations is 45.5%, which is similar to that of the large trials. Conclusions: The introduction of therapeutic hypothermia for neonates with perinatal asphyxia in the Netherlands and Flanders has been rapid and successful, with results similar to findings in the randomised controlled trials. Copyright © 2013 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Published
2013
Full Text
View/download PDF

44. Mutation of TBCE causes hypoparathyroidism–retardation–dysmorphism and autosomal recessive Kenny–Caffey syndrome.

Author

Parvari, Ruti, Hershkovitz, Eli, Grossman, Nili, Gorodischer, Rafael, Loeys, Bart, Zecic, Alexandra, Mortier, Geert, Gregory, Simon, Sharony, Reuven, Kambouris, Marios, Sakati, Nadia, Meyer, Brian F., Al Aqeel, Aida I., Al Humaidan, Abdul Karim, Al Zanhrani, Fatma, Al Swaid, Abdulrahman, Al Othman, Johara, Diaz, George A., Weiner, Rory, and Khan, K. Tahseen S.

Subjects
GENETIC mutation, MICROTUBULES, HYPOPARATHYROIDISM
Abstract

The syndrome of congenital hypoparathyroidism, mental retardation, facial dysmorphism and extreme growth failure (HRD or Sanjad-Sakati syndrome; OMIM 241410) is an autosomal recessive disorder reported almost exclusively in Middle Eastern populations[SUP1-3]. A similar syndrome with the additional features of osteosclerosis and recurrent bacterial infections has been classified as autosomal recessive Kenny-Caffey syndrome[SUP4] (AR-KCS; OMIM 244460). Both traits have previously been mapped to chromosome 1q43-44 (refs 5,6) and, despite the observed clinical variability, share an ancestral haplotype, suggesting a common founder mutation[SUP7]. We describe refinement of the critical region to an interval of roughly 230 kb and identification of deletion and truncation mutations of TBCE in affected individuals. The gene TBCE encodes one of several chaperone proteins required for the proper folding of α-tubulin subunits and the formation of α-β-tubulin heterodimers. Analysis of diseased fibroblasts and lymphoblastoid cells showed lower microtubule density at the microtubule-organizing center (MTOC) and perturbed microtubule polarity in diseased cells. Immunofluorescence and ultrastructural studies showed disturbances in subcellular organelles that require microtubules for membrane trafficking, such as the Golgi and late endosomal compartments. These findings demonstrate that HRD and AR-KCS are chaperone diseases caused by a genetic defect in the tubulin assembly pathway, and establish a potential connection between tubulin physiology and the development of the parathyroid. [ABSTRACT FROM AUTHOR]

Published
2002

Catalog

Books, media, physical & digital resources
See catalog results