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1. Identifying effect modifiers of systemic hydrocortisone treatment initiated 7-14 days after birth in ventilated very preterm infants on long-term outcome: secondary analysis of a randomised controlled trial

Author

Halbmeijer, N.M., Sonnaert, M., Swarte, R.M., Koopman-Esseboom, C., Stuijvenberg, M. van, Mulder-de Tollenaer, S., Tan, R., Mohns, T., Bruneel, E., Steiner, K., Kramer, B.W., Debeer, A., Weissenbruch, M.M. van, Marechal, Y., Blom, H., Plaskie, K., Offringa, M., Merkus, M.P., Onland, W., Leemhuis, A.G., Kaam, A.H. van, Halbmeijer, N.M., Sonnaert, M., Swarte, R.M., Koopman-Esseboom, C., Stuijvenberg, M. van, Mulder-de Tollenaer, S., Tan, R., Mohns, T., Bruneel, E., Steiner, K., Kramer, B.W., Debeer, A., Weissenbruch, M.M. van, Marechal, Y., Blom, H., Plaskie, K., Offringa, M., Merkus, M.P., Onland, W., Leemhuis, A.G., and Kaam, A.H. van

Abstract

Contains fulltext : 305092.pdf (Publisher’s version ) (Closed access), OBJECTIVE: To explore clinical effect modifiers of systemic hydrocortisone in ventilated very preterm infants for survival and neurodevelopmental outcome at 2 years' corrected age (CA). DESIGN: Secondary analysis of a randomised placebo-controlled trial. SETTING: Dutch and Belgian neonatal intensive care units. PATIENTS: Infants born <30 weeks' gestational age (GA), ventilator-dependent in the second week of postnatal life. INTERVENTION: Infants were randomly assigned to systemic hydrocortisone (cumulative dose 72.5 mg/kg; n=182) or placebo (n=190). MAIN OUTCOME MEASURES: The composite of death or neurodevelopmental impairment (NDI) at 2 years' CA and its components. Candidate effect modifiers (GA, small for GA, respiratory index, sex, multiple births, risk of moderate/severe bronchopulmonary dysplasia or death) were analysed using regression models with interaction terms and subpopulation treatment effect pattern plots. RESULTS: The composite outcome was available in 356 (96.0%) of 371 patients (one consent withdrawn). For this outcome, treatment effect heterogeneity was seen across GA subgroups (<27 weeks: hydrocortisone (n=141) vs placebo (n=156), 54.6% vs 66.2%; OR 0.61 (95% CI 0.38 to 0.98); ≥27 weeks: hydrocortisone (n=30) vs placebo (n=31), 66.7% vs 45.2%; OR 2.43 (95% CI 0.86 to 6.85); p=0.02 for interaction). This effect was also found for the component death (<27 weeks: 20.1% vs 32.1%; OR 0.53 (95% CI 0.32 to 0.90); ≥27 weeks: 28.1% vs 16.1%; OR 2.04 (95% CI 0.60 to 6.95); p=0.049 for interaction) but not for the component NDI. No differential treatment effects were observed across other subgroups. CONCLUSION: This secondary analysis suggests that in infants <27 weeks' GA, systemic hydrocortisone may improve the outcome death or NDI, mainly driven by its component death. There was insufficient evidence for other selected candidate effect modifiers.

Published
2024

2. 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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3. 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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4. Phenobarbital, Midazolam Pharmacokinetics, Effectiveness, and Drug-Drug Interaction in Asphyxiated Neonates Undergoing Therapeutic Hypothermia

Author

Favie, LMA, Groenendaal, F, Broek, MPB, Rademaker, CMA, de Haan, TR, van Straaten, HL, Dijk, PH, van Heijst, A, Simons, SHP (Sinno), Dijkman, KP, Rijken, M, Zonnenberg, IA, Cools, F, Zecic, A, v.d. Lee, JH, Nuytemans, D, van Bel, F, Egberts, TC, Huitema, ADR, Brouwer, MJ, Tollenaer, SM, Jebbink-Akkerman, L, Liem, D, Steiner, K, Dudink, J, de Jonge, RCJ, Bos, Annelies, Sonnaert, M, Camfferman, FA, Favie, LMA, Groenendaal, F, Broek, MPB, Rademaker, CMA, de Haan, TR, van Straaten, HL, Dijk, PH, van Heijst, A, Simons, SHP (Sinno), Dijkman, KP, Rijken, M, Zonnenberg, IA, Cools, F, Zecic, A, v.d. Lee, JH, Nuytemans, D, van Bel, F, Egberts, TC, Huitema, ADR, Brouwer, MJ, Tollenaer, SM, Jebbink-Akkerman, L, Liem, D, Steiner, K, Dudink, J, de Jonge, RCJ, Bos, Annelies, Sonnaert, M, and Camfferman, FA

Published
2019

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

Author

Favie, LMA, Groenendaal, F, van den Broek, MPH, Rademaker, CMA, de Haan, TR, van Straaten, HLM (Henrica / Henriette), Dijk, PH, van Heijst, A, Dudink, J, Dijkman, KP, Rijken, M, Zonnenberg, IA, Cools, F, Zecic, A, v.d. Lee, JH, Nuytemans, D, van Bel, F, Egberts, TCG (Toine), Huitema, ADR, Brouwer, MJ, Tollenaer, SM, Jebbink-Akkerman, L, Liem, D, Steiner, K, Simons, SHP (Sinno), de Jonge, RCJ, Bos, AA (Annelies), Sonnaert, M, Camfferman, FA, Favie, LMA, Groenendaal, F, van den Broek, MPH, Rademaker, CMA, de Haan, TR, van Straaten, HLM (Henrica / Henriette), Dijk, PH, van Heijst, A, Dudink, J, Dijkman, KP, Rijken, M, Zonnenberg, IA, Cools, F, Zecic, A, v.d. Lee, JH, Nuytemans, D, van Bel, F, Egberts, TCG (Toine), Huitema, ADR, Brouwer, MJ, Tollenaer, SM, Jebbink-Akkerman, L, Liem, D, Steiner, K, Simons, SHP (Sinno), de Jonge, RCJ, Bos, AA (Annelies), Sonnaert, M, and Camfferman, FA

Published
2019

6. Evaluation of a system-specific function to describe the pharmacokinetics of benzylpenicillin in term neonates undergoing moderate hypothermia

Author

Bijleveld, Y. (Yuma), Haan, T.R. (Timo Robert) de, Lee, J.H. (Johanna) van der, Groenendaal, F. (Floris), Dijk, P.H. (Peter), Heijst, A.F.J. (Arno) van, Jonge, R.C.J. (Rogier) de, Dijkman, K.P. (Koen), Straaten, H.L.M. (Henrica) van, Rijken, M. (Monique), Zonnenberg, I. (Inge), Cools, F. (Filip), Zecic, A. (Alexandra), Nuytemans, K., Kaam, A.H. (Anton) van, Mathot, R.A. (Ron), Brouwer, M.J. (Mieke J.), Broek, M.P.H. (Marcel) van den, Rademaker, C.M.A. (Carin), Liem, D. (Djien), Steiner, K. (Katerina), Simons, S.H.P. (Sinno), Bos, A.A. (Annelies), Mulder-De Tollenaer, S.M. (S. M.), Jebbink-Akkerman, L.J.M.G. (L.J.M. Groot), Sonnaert, M. (Michel), Camfferman, F.A. (Fleur), Bijleveld, Y. (Yuma), Haan, T.R. (Timo Robert) de, Lee, J.H. (Johanna) van der, Groenendaal, F. (Floris), Dijk, P.H. (Peter), Heijst, A.F.J. (Arno) van, Jonge, R.C.J. (Rogier) de, Dijkman, K.P. (Koen), Straaten, H.L.M. (Henrica) van, Rijken, M. (Monique), Zonnenberg, I. (Inge), Cools, F. (Filip), Zecic, A. (Alexandra), Nuytemans, K., Kaam, A.H. (Anton) van, Mathot, R.A. (Ron), Brouwer, M.J. (Mieke J.), Broek, M.P.H. (Marcel) van den, Rademaker, C.M.A. (Carin), Liem, D. (Djien), Steiner, K. (Katerina), Simons, S.H.P. (Sinno), Bos, A.A. (Annelies), Mulder-De Tollenaer, S.M. (S. M.), Jebbink-Akkerman, L.J.M.G. (L.J.M. Groot), Sonnaert, M. (Michel), and Camfferman, F.A. (Fleur)

Abstract

The pharmacokinetic (PK) properties of intravenous (i.v.) benzylpenicillin in term neonates undergoing moderate hypothermia after perinatal asphyxia were evaluated, as they have been unknown until now. A system-specific modeling approach was applied, in which our recently developed covariate model describing developmental and temperature-induced changes in amoxicillin clearance (CL) in the same patient study population was incorporated into a population PK model of benzylpenicillin with a priori birthweight (BW)-based allometric scaling. Pediatric population covariate models describing the developmental changes in drug elimination may constitute system-specific information and may therefore be incorporated into PK models of drugs cleared through the same pathway. The performance of this system-specific model was compared to that of a reference model. Furthermore, Monte-Carlo simulations were performed to evaluate the optimal dose. The systemspecific model performed as well as the reference model. Significant correlations were found between CL and postnatal age (PNA), gestational age (GA), body temperature (TEMP), urine output (UO; system-specific model), and multiorgan failure (reference model). For a typical patient with a GA of 40 weeks, BW of 3, 000 g, PNA of 2 days (TEMP, 33.5°C), and normal UO (2 ml/kg/h), benzylpenicillin CL was 0.48 liter/h (interindividual variability [IIV] of 49%) and the volume of distribution of the central compartment was 0.62 liter/kg (IIV of 53%) in the system-specific model. Based on simulations, we advise a benzylpenicillin i.v. dose regimen of 75, 000 IU/kg/day every 8 h (q8h), 150, 000 IU/kg/day q8h, and 200, 000 IU/kg/day q6h for patients with GAs of 36 to 37 weeks, 38 to 41 weeks, and ≥42 weeks, respectively. Thesystem-specific model may be used for other drugs cleared through the same pathway accelerating model development.

Published
2018
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