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

Author

Favie, L.M.A., Groenendaal, F. (Floris), Broek, M.P.B. (Thijs) van den, Rademaker, C.M.A., Haan, T.R. (Timo Robert) de, van Straaten, H.L., Dijk, P.H. (Peter), van Heijst, A., Simons, S.H.P. (Sinno), Dijkman, K.P. (Koen), Rijken, M., Zonnenberg, I. (Inge), Cools, F. (Filip), Zecic, A. (Alexandra), Lee, J. (Jacqueline) van der, Nuytemans, D, Bel, F. (Frank) van, Egberts, TC, Huitema, A.D.R. (Alwin), de Brouwer, M.J., Tollenaer, S.M. (S.) de, Jebbink-Akkerman, L., Liem, D. (Djien), Steiner, K. (Katerina), Dudink, J. (Jeroen), de Jonge, R.C.J., Bos, A.A. (Arjan) van den, Sonnaert, M., Camfferman, FA, Favie, L.M.A., Groenendaal, F. (Floris), Broek, M.P.B. (Thijs) van den, Rademaker, C.M.A., Haan, T.R. (Timo Robert) de, van Straaten, H.L., Dijk, P.H. (Peter), van Heijst, A., Simons, S.H.P. (Sinno), Dijkman, K.P. (Koen), Rijken, M., Zonnenberg, I. (Inge), Cools, F. (Filip), Zecic, A. (Alexandra), Lee, J. (Jacqueline) van der, Nuytemans, D, Bel, F. (Frank) van, Egberts, TC, Huitema, A.D.R. (Alwin), de Brouwer, M.J., Tollenaer, S.M. (S.) de, Jebbink-Akkerman, L., Liem, D. (Djien), Steiner, K. (Katerina), Dudink, J. (Jeroen), de Jonge, R.C.J., Bos, A.A. (Arjan) van den, Sonnaert, M., and Camfferman, FA

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 addon 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.

Published
2019
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2. Pharmacokinetics of morphine in encephalopathic neonates treated with therapeutic hypothermia

Author

Favie, L.M.A., Groenendaal, F. (Floris), Broek, M.P.H. (Marcel) van den, Rademaker, C.M.A., Haan, T.R. (Timo Robert) de, Straaten, H.L.M. (Henrica) van, Dijk, P.H. (Peter), van Heijst, A., Dudink, J. (Jeroen), Dijkman, K.P. (Koen), Rijken, M., Zonnenberg, I. (Inge), Cools, F. (Filip), Zecic, A. (Alexandra), Lee, J. (Jacqueline) van der, Nuytemans, D, Bel, F. (Frank) van, Egberts, T.C.G. (Toine), Huitema, A.D.R. (Alwin), de Brouwer, M.J., Tollenaer, S.M. (S.) de, Jebbink-Akkerman, L., Liem, D. (Djien), Steiner, K. (Katerina), Simons, S.H.P. (Sinno), de Jonge, R.C.J., Bos, A.A. (Arjan) van den, Sonnaert, M., Camfferman, FA, Favie, L.M.A., Groenendaal, F. (Floris), Broek, M.P.H. (Marcel) van den, Rademaker, C.M.A., Haan, T.R. (Timo Robert) de, Straaten, H.L.M. (Henrica) van, Dijk, P.H. (Peter), van Heijst, A., Dudink, J. (Jeroen), Dijkman, K.P. (Koen), Rijken, M., Zonnenberg, I. (Inge), Cools, F. (Filip), Zecic, A. (Alexandra), Lee, J. (Jacqueline) van der, Nuytemans, D, Bel, F. (Frank) van, Egberts, T.C.G. (Toine), Huitema, A.D.R. (Alwin), de Brouwer, M.J., Tollenaer, S.M. (S.) de, Jebbink-Akkerman, L., Liem, D. (Djien), Steiner, K. (Katerina), Simons, S.H.P. (Sinno), de Jonge, R.C.J., Bos, A.A. (Arjan) van den, Sonnaert, M., and Camfferman, FA

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

Published
2019
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3. Early treatment versus expectative management of patent ductus arteriosus in preterm infants

Author

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

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 28weeks. 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<28weeks) with an echocardiographic-confirmed PDA with a transductal diameter>1.5mm. Early treatment (between 24 and 72h 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 36weeks. 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 28weeks, with a PDA an expectative management is non-inferior to

Published
2018
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4. Longitudinal study of computerized cardiotocography in early fetal growth restriction

Author

Wolf, H. (Hans Uwe), Arabin, B. (Birgit), Lees, C. (Christoph), Oepkes, D., Prefumo, F. (F.), Thilaganathan, B. (Baskaran), Todros, T. (Tullia), Visser, G.H. (Gerhard Henk), Bilardo, C.M. (Caterina Maddalena), Derks, J.B. (Jan), Diemert, A. (Anke), Duvekot, J.J. (Hans), Ferrazzi, E. (Enrico), Frusca, T. (T.), Hecher, K. (Kurt), Marlow, N. (Neil), Martinelli, P. (Pasquale), Ostermayer, E. (Eva), Papageorghiou, A.T. (A.), Scheepers, H.C.J. (Hubertina), Schlembach, D. (Dietmar), Schneider, K.T.M. (K. T.M.), Valcamonico, A. (Adriana), Wassenaer-Leemhuis, A.G. (Aleid) van, Ganzevoort, W. (Wessel), Aktas, A. (Ayse), Borgione, S. (Silvia), Brezinka, C.A. (Christoph), Calvert, S. (Sandra), Chaoui, R. (R.), Cornette, J.M.J. (Jerome M. J.), Diehl, T. (Thilo), Eyck, J. (Jim) van, Fratelli, N. (N.), van Haastert, I.-L. (Inge-Lot), Johnson, S. (Samantha), Lobmaier, S. (Silvia), Lopriore, E., Mansi, G. (Giuseppina), Missfelder-Lobos, H. (H.), Martelli, P. (Paola), Maso, G. (G.), Maurer-Fellbaum, U. (Ute), Van Charante, N.M. (Nico Mensing), Tollenaer, S.M. (S.) de, Moore, T. (Tamanna), Napolitano, R. (Raffaele), Oberto, M. (M.), Ogge, G. (G.), Post, J.A.M. (Joris) van der, Preston, L. (Lucy), Raimondi, F. (Francesco), Reiss, I.K.M. (Irwin), Rigano, S. (Serena), Schuit, E. (Ewoud), Skabar, A. (Aldo), Spaanderman, M.E.A., Weisglas–Kuperus, N. (Nynke), Zimmermann, A. (Andrea), Wolf, H. (Hans Uwe), Arabin, B. (Birgit), Lees, C. (Christoph), Oepkes, D., Prefumo, F. (F.), Thilaganathan, B. (Baskaran), Todros, T. (Tullia), Visser, G.H. (Gerhard Henk), Bilardo, C.M. (Caterina Maddalena), Derks, J.B. (Jan), Diemert, A. (Anke), Duvekot, J.J. (Hans), Ferrazzi, E. (Enrico), Frusca, T. (T.), Hecher, K. (Kurt), Marlow, N. (Neil), Martinelli, P. (Pasquale), Ostermayer, E. (Eva), Papageorghiou, A.T. (A.), Scheepers, H.C.J. (Hubertina), Schlembach, D. (Dietmar), Schneider, K.T.M. (K. T.M.), Valcamonico, A. (Adriana), Wassenaer-Leemhuis, A.G. (Aleid) van, Ganzevoort, W. (Wessel), Aktas, A. (Ayse), Borgione, S. (Silvia), Brezinka, C.A. (Christoph), Calvert, S. (Sandra), Chaoui, R. (R.), Cornette, J.M.J. (Jerome M. J.), Diehl, T. (Thilo), Eyck, J. (Jim) van, Fratelli, N. (N.), van Haastert, I.-L. (Inge-Lot), Johnson, S. (Samantha), Lobmaier, S. (Silvia), Lopriore, E., Mansi, G. (Giuseppina), Missfelder-Lobos, H. (H.), Martelli, P. (Paola), Maso, G. (G.), Maurer-Fellbaum, U. (Ute), Van Charante, N.M. (Nico Mensing), Tollenaer, S.M. (S.) de, Moore, T. (Tamanna), Napolitano, R. (Raffaele), Oberto, M. (M.), Ogge, G. (G.), Post, J.A.M. (Joris) van der, Preston, L. (Lucy), Raimondi, F. (Francesco), Reiss, I.K.M. (Irwin), Rigano, S. (Serena), Schuit, E. (Ewoud), Skabar, A. (Aldo), Spaanderman, M.E.A., Weisglas–Kuperus, N. (Nynke), and Zimmermann, A. (Andrea)

Abstract

Objectives: To explore whether, in early fetal growth restriction (FGR), the longitudinal pattern of fetal heart rate (FHR) short-term variation (STV) can be used to identify imminent fetal distress and whether abnormalities of FHR recordings are associated with 2-year infant outcome. Methods: The original TRUFFLE study assessed whether, in early FGR, delivery based on ductus venosus (DV) Doppler pulsatility index (PI), in combination with safety-net criteria of very low STV on cardiotocography (CTG) and/or recurrent FHR decelerations, could improve 2-year infant survival without neurological impairment in comparison with delivery based on CTG monitoring only. This was a secondary analysis of women who delivered before 32 weeks and had consecutive STV data recorded > 3 days before delivery and known infant outcome at 2 years of age. Women who received corticosteroids within 3 days of delivery were excluded. Individual regression line algorithms of all STV values, except the last one before delivery, were calculated. Life tables and Cox regression analysis were used to calculate the daily risk for low STV or very low STV and/or FHR decelerations (below DV group safety-net criteria) and to assess which parameters were associated with this risk. Furthermore, it was assessed whether STV pattern, last STV value or recurrent FHR decelerations were associated with 2-year infant outcome. Results: One hundred and forty-nine women from the original TRUFFLE study met the inclusion criteria. Using the individual STV regression lines, prediction of a last STV below the cut-off used by the CTG monitoring group had sensitivity of 42% and specificity of 91%. For each day after study inclusion, the median risk for low STV (CTG group cut-off) was 4% (interquartile range (IQR), 2–7%) and for very low STV and/or recurrent FHR decelerations (below DV group safety-net criteria) was 5% (IQR, 4–7%). Measures of STV pattern, fetal Doppler (arterial or venous), birth-weight multiples of the

Published
2017
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