8 results on '"de Boer IP"'
Search Results
2. Effect of allopurinol in addition to hypothermia treatment in neonates for hypoxic-ischemic brain injury on neurocognitive outcome (ALBINO): study protocol of a blinded randomized placebo-controlled parallel group multicenter trial for superiority (phase III)
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Benders, MJNL, Klebermass-Schrehof, K, Metsaranta, M, Rudiger, M, Poets, CF, Benders, M, Allegaert, K, Naulaers, G, Guimaraes, H, Stiris, T, Vanhatalo, S, Metsvaht, T, Engel, C, Maiwald, CA, von Oldershausen, G, Bergmann, I, Weiss, M, Wichera, CJBR, Eichhorn, A, Raubuch, M, Schuler, B, van Veldhuizen, CKW, Lameris, B, Jacobs, Y, van der Vlught-Meijer, R, Kliniken, T, Griesmaier, E, Salzburg, U, Brandner, J, Tackoen, M, Reibel, R, Cornette, L, Viellevoye, LR, Saik, P, Kaar, R, Andresson, P, Franz, AR, Carus, CG, Winkler, S, Hoehn, T, Teig, N, Schroth, M, Fusch, C, Thome, UH, Ehrhardt, H, Cattarossi, L, Mauro, I, Baraldi, E, Carnielli, V, Paterlini, MG, Napolitano, M, Faldini, F, Lista, GL, Barbarini, M, Pagani, L, Anna, S, Mastretta, E, Vento, G, Fumagalli, MM, Binotti, NM, van Weissenbruch, MM, van Straaten, HLM, Annink, KV, van Bel, F, Dudink, J, Derks, JB, de Boer, IP, Meijssen, CB, de Haan, TR, van Rooij, LG, van Hillegersberg, JL, van Dongen, M, Dassel, ACM, Dijkman, KP, van Houten, MA, van der Schoor, SRD, Nestaas, E, Mazela, J, Karpinski, L, Vilan, AI, de Pinho, LF, Ferraz, C, Pereira, A, Barroso, R, da Graca, M, Tome, T, Pinto, F, Vento, M, Rodilla, JM, Luz, M, Pico, C, Camprubi, MC, Suazo, JAH, Valverde, E, Lorenzo, JRF, Orgado, JM, Boix, H, Parrilla, FJ, Blanco, D, Moral-Pumarega, MT, Bassler, D, Maletzki, J, Knoepfli, C, Hagmann, C, Kleber, M, Schulzke, S, Stocker, M, Birkenmaier, A, Riedel, T, and ALBINO Study Grp
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Hypothermia therapy ,Perinatal asphyxia ,Allopurinol ,Neonatal oxygen deficiency ,Hypoxic-ischemic encephalopathy ,Cerebral palsy ,Childbirth outcome ,Brain injury - Abstract
BackgroundPerinatal asphyxia and resulting hypoxic-ischemic encephalopathy is a major cause of death and long-term disability in term born neonates. Up to 20,000 infants each year are affected by HIE in Europe and even more in regions with lower level of perinatal care. The only established therapy to improve outcome in these infants is therapeutic hypothermia. Allopurinol is a xanthine oxidase inhibitor that reduces the production of oxygen radicals as superoxide, which contributes to secondary energy failure and apoptosis in neurons and glial cells after reperfusion of hypoxic brain tissue and may further improve outcome if administered in addition to therapeutic hypothermia.MethodsThis study on the effects of ALlopurinol in addition to hypothermia treatment for hypoxic-ischemic Brain Injury on Neurocognitive Outcome (ALBINO), is a European double-blinded randomized placebo-controlled parallel group multicenter trial (Phase III) to evaluate the effect of postnatal allopurinol administered in addition to standard of care (including therapeutic hypothermia if indicated) on the incidence of death and severe neurodevelopmental impairment at 24months of age in newborns with perinatal hypoxic-ischemic insult and signs of potentially evolving encephalopathy. Allopurinol or placebo will be given in addition to therapeutic hypothermia (where indicated) to infants with a gestational age36weeks and a birth weight2500g, with severe perinatal asphyxia and potentially evolving encephalopathy. The primary endpoint of this study will be death or severe neurodevelopmental impairment versus survival without severe neurodevelopmental impairment at the age of two years. Effects on brain injury by magnetic resonance imaging and cerebral ultrasound, electric brain activity, concentrations of peroxidation products and S100B, will also be studied along with effects on heart function and pharmacokinetics of allopurinol after iv-infusion.DiscussionThis trial will provide data to assess the efficacy and safety of early postnatal allopurinol in term infants with evolving hypoxic-ischemic encephalopathy. If proven efficacious and safe, allopurinol could become part of a neuroprotective pharmacological treatment strategy in addition to therapeutic hypothermia in children with perinatal asphyxia.Trial registrationNCT03162653, www.ClinicalTrials.gov, May 22, 2017.
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- 2019
3. Maternal allopurinol administration during suspected fetal hypoxia: a novel neuroprotective intervention? A multicentre randomised placebo controlled trial.
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Kaandorp JJ, Benders MJ, Schuit E, Rademaker CM, Oudijk MA, Porath MM, Oetomo SB, Wouters MG, van Elburg RM, Franssen MT, Bos AF, de Haan TR, Boon J, de Boer IP, Rijnders RJ, Jacobs CJ, Scheepers LH, Gavilanes DA, Bloemenkamp KW, Rijken M, van Meir CA, von Lindern JS, Huisjes AJ, Bakker SC, Mol BW, Visser GH, Van Bel F, and Derks JB
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- Adult, Aldehydes blood, Allopurinol blood, Dinoprost analogs & derivatives, Dinoprost blood, Double-Blind Method, Female, Fetal Blood chemistry, Humans, Ketones blood, Male, Maternal-Fetal Exchange, Oxypurinol blood, Pregnancy, S100 Calcium Binding Protein beta Subunit blood, Allopurinol therapeutic use, Enzyme Inhibitors therapeutic use, Fetal Hypoxia drug therapy, Xanthine Oxidase antagonists & inhibitors
- Abstract
Objective: To determine whether maternal allopurinol treatment during suspected fetal hypoxia would reduce the release of biomarkers associated with neonatal brain damage., Design: A randomised double-blind placebo controlled multicentre trial., Patients: We studied women in labour at term with clinical indices of fetal hypoxia, prompting immediate delivery., Setting: Delivery rooms of 11 Dutch hospitals., Intervention: When immediate delivery was foreseen based on suspected fetal hypoxia, women were allocated to receive allopurinol 500 mg intravenous (ALLO) or placebo intravenous (CONT)., Main Outcome Measures: Primary endpoint was the difference in cord S100ß, a tissue-specific biomarker for brain damage., Results: 222 women were randomised to receive allopurinol (ALLO, n=111) or placebo (CONT, n=111). Cord S100ß was not significantly different between the two groups: 44.5 pg/mL (IQR 20.2-71.4) in the ALLO group versus 54.9 pg/mL (IQR 26.8-94.7) in the CONT group (difference in median -7.69 (95% CI -24.9 to 9.52)). Post hoc subgroup analysis showed a potential treatment effect of allopurinol on the proportion of infants with a cord S100ß value above the 75th percentile in girls (ALLO n=5 (12%) vs CONT n=10 (31%); risk ratio (RR) 0.37 (95% CI 0.14 to 0.99)) but not in boys (ALLO n=18 (32%) vs CONT n=15 (25%); RR 1.4 (95% CI 0.84 to 2.3)). Also, cord neuroketal levels were significantly lower in girls treated with allopurinol as compared with placebo treated girls: 18.0 pg/mL (95% CI 12.1 to 26.9) in the ALLO group versus 32.2 pg/mL (95% CI 22.7 to 45.7) in the CONT group (geometric mean difference -16.4 (95% CI -24.6 to -1.64))., Conclusions: Maternal treatment with allopurinol during fetal hypoxia did not significantly lower neuronal damage markers in cord blood. Post hoc analysis revealed a potential beneficial treatment effect in girls., Trial Registration Number: NCT00189007, Dutch Trial Register NTR1383., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)
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- 2015
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4. Antenatal allopurinol for reduction of birth asphyxia induced brain damage (ALLO-Trial); a randomized double blind placebo controlled multicenter study.
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Kaandorp JJ, Benders MJ, Rademaker CM, Torrance HL, Oudijk MA, de Haan TR, Bloemenkamp KW, Rijken M, van Pampus MG, Bos AF, Porath MM, Oetomo SB, Willekes C, Gavilanes AW, Wouters MG, van Elburg RM, Huisjes AJ, Bakker SC, van Meir CA, von Lindern J, Boon J, de Boer IP, Rijnders RJ, Jacobs CJ, Uiterwaal CS, Mol BW, Visser GH, van Bel F, and Derks JB
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- Asphyxia Neonatorum blood, Asphyxia Neonatorum complications, Asphyxia Neonatorum epidemiology, Biomarkers blood, Double-Blind Method, Female, Fetal Hypoxia blood, Fetal Hypoxia complications, Humans, Hypoxia-Ischemia, Brain blood, Hypoxia-Ischemia, Brain etiology, Infant, Newborn, Multivariate Analysis, Nerve Growth Factors blood, Netherlands epidemiology, Phosphopyruvate Hydratase blood, Pilot Projects, Pregnancy, Prospective Studies, Regression Analysis, S100 Calcium Binding Protein beta Subunit, S100 Proteins blood, Xanthine Oxidase antagonists & inhibitors, Allopurinol therapeutic use, Asphyxia Neonatorum prevention & control, Fetal Hypoxia prevention & control, Free Radical Scavengers therapeutic use, Hypoxia-Ischemia, Brain prevention & control, Prenatal Care methods
- Abstract
Background: Hypoxic-ischaemic encephalopathy is associated with development of cerebral palsy and cognitive disability later in life and is therefore one of the fundamental problems in perinatal medicine. The xanthine-oxidase inhibitor allopurinol reduces the formation of free radicals, thereby limiting the amount of hypoxia-reperfusion damage. In case of suspected intra-uterine hypoxia, both animal and human studies suggest that maternal administration of allopurinol immediately prior to delivery reduces hypoxic-ischaemic encephalopathy., Methods/design: The proposed trial is a randomized double blind placebo controlled multicenter study in pregnant women at term in whom the foetus is suspected of intra-uterine hypoxia.Allopurinol 500 mg IV or placebo will be administered antenatally to the pregnant woman when foetal hypoxia is suspected. Foetal distress is being diagnosed by the clinician as an abnormal or non-reassuring foetal heart rate trace, preferably accompanied by either significant ST-wave abnormalities (as detected by the STAN-monitor) or an abnormal foetal blood scalp sampling (pH < 7.20).Primary outcome measures are the amount of S100B (a marker for brain tissue damage) and the severity of oxidative stress (measured by isoprostane, neuroprostane, non protein bound iron and hypoxanthine), both measured in umbilical cord blood. Secondary outcome measures are neonatal mortality, serious composite neonatal morbidity and long-term neurological outcome. Furthermore pharmacokinetics and pharmacodynamics will be investigated.We expect an inclusion of 220 patients (110 per group) to be feasible in an inclusion period of two years. Given a suspected mean value of S100B of 1.05 ug/L (SD 0.37 ug/L) in the placebo group this trial has a power of 90% (alpha 0.05) to detect a mean value of S100B of 0.89 ug/L (SD 0.37 ug/L) in the 'allopurinol-treated' group (z-test2-sided). Analysis will be by intention to treat and it allows for one interim analysis., Discussion: In this trial we aim to answer the question whether antenatal allopurinol administration reduces hypoxic-ischaemic encephalopathy in neonates exposed to foetal hypoxia., Trial Registration Number: Clinical Trials, protocol registration system: NCT00189007.
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- 2010
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5. Azathioprine treatment during lactation.
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Zelinkova Z, De Boer IP, Van Dijke MJ, Kuipers EJ, and Van Der Woude CJ
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- Adult, Azathioprine pharmacokinetics, Breast Feeding, Female, Follow-Up Studies, Humans, Immunosuppressive Agents pharmacokinetics, Immunosuppressive Agents therapeutic use, Lactation drug effects, Milk, Human drug effects, Pregnancy, Azathioprine therapeutic use, Crohn Disease drug therapy, Lactation metabolism, Milk, Human metabolism
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- 2009
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6. Comparing brain white matter on sequential cranial ultrasound and MRI in very preterm infants.
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Leijser LM, Liauw L, Veen S, de Boer IP, Walther FJ, and van Wezel-Meijler G
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- Brain physiopathology, Child, Preschool, Follow-Up Studies, Gestational Age, Humans, Infant, Infant, Newborn, Infant, Premature, Infant, Premature, Diseases diagnostic imaging, Infant, Premature, Diseases pathology, Predictive Value of Tests, Psychomotor Performance physiology, Retrospective Studies, Severity of Illness Index, Brain growth & development, Brain pathology, Child Development physiology, Echoencephalography, Infant, Premature, Diseases physiopathology, Magnetic Resonance Imaging
- Abstract
Introduction: Periventricular white matter (WM) echodensities, frequently seen in preterm infants, can be associated with suboptimal neurodevelopment. Major WM injury is well detected on cranial ultrasound (cUS). cUS seems less sensitive for diffuse or more subtle WM injury. Our aim was to assess the value of cUS and magnetic resonance imaging (MRI) for evaluating WM changes and the predictive value of cUS and/or MRI findings for neurodevelopmental outcome in very preterm infants with normal to severely abnormal WM on sequential high-quality cUS., Materials and Methods: Very preterm infants (<32 weeks) who had sequential cUS and one MRI within the first three postnatal months were included. Periventricular WM on cUS and MRI was compared and correlated with neurodevelopmental outcome at 2 years corrected age., Results: Forty preterm infants were studied; outcome data were available in 32. WM changes on sequential cUS were predictive of WM changes on MRI. Severely abnormal WM on cUS/MRI was predictive of adverse outcome, and normal-mildly abnormal WM of favorable outcome. Moderately abnormal WM on cUS/MRI was associated with variable outcome. Additional MRI slightly increased the predictive value of cUS in severe WM changes., Conclusion: Sequential cUS in preterm infants is reliable for detecting WM changes and predicting favorable and severely abnormal outcome. Conventional and diffusion-weighted MRI sequences before term equivalent age in very preterm infants, suggested on cUS to have mild to moderately abnormal WM, do not seem to be warranted.
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- 2008
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7. Pediatric outcome in Rhesus hemolytic disease treated with and without intrauterine transfusion.
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De Boer IP, Zeestraten EC, Lopriore E, van Kamp IL, Kanhai HH, and Walther FJ
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- Birth Weight, Child Development physiology, Child, Preschool, Cohort Studies, Female, Follow-Up Studies, Gestational Age, Humans, Infant, Infant, Newborn, Intensive Care Units, Neonatal, Phototherapy methods, Pregnancy, Probability, Reference Values, Retrospective Studies, Rh Isoimmunization diagnosis, Rh Isoimmunization mortality, Risk Assessment, Survival Rate, Treatment Outcome, Blood Transfusion, Intrauterine methods, Erythrocyte Transfusion methods, Exchange Transfusion, Whole Blood methods, Rh Isoimmunization therapy
- Abstract
Objective: To study the short-term morbidity in Rhesus hemolytic disease of infants treated either with or without intrauterine transfusions (IUT)., Study Design: All term and near term infants (gestational age > or = 36 weeks) with neonatal Rhesus hemolytic disease admitted to our center between January 2000-March 2005 were retrospectively included in the study. We recorded the duration of phototherapy, the need of exchange transfusions, and the need of top-up red blood cell transfusions until 6 months of age., Results: A total of 89 infants were included, of whom 52 received at least one IUT. Duration of phototherapy in the IUT and no-IUT group was 3.8 and 5.1 days, respectively (P = .01). The percentage of infants requiring an exchange transfusion in the IUT group was 71% compared to 65% in the no-IUT group (P = .64). The percentage of infants requiring a top-up transfusion in the IUT and no-IUT group was 77% and 26.5%, respectively (P < .01)., Conclusion: Infants with Rhesus hemolytic disease treated with IUT required less days of phototherapy and more top-up red blood cell transfusions than neonates without IUT. However, the need for exchange transfusion was similar in both groups.
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- 2008
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8. Botulinum toxin in cervical dystonia: low dosage with electromyographic guidance.
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Brans JW, de Boer IP, Aramideh M, Ongerboer de Visser BW, and Speelman JD
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- Adult, Aged, Animals, Botulinum Toxins adverse effects, Dose-Response Relationship, Drug, Electromyography, Female, Humans, Injections, Intramuscular, Male, Mice, Middle Aged, Neck, Retrospective Studies, Treatment Outcome, Botulinum Toxins therapeutic use, Dystonia drug therapy
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Sixty patients with idiopathic cervical dystonia were treated a total of 240 times with botulinum toxin type A (BTA). Selected muscles were injected with BTA under electromyographic (EMG) guidance. The clinical effect was measured on the Tsui scale and a 10-point anchored visual analogue scale. A dosage of 150-300 mouse units was used in 77% of the treatments (mean 204 mouse units). Based on the Tsui scale, 45% of 240 treatments were still effective at the moment of reinjection (median improvement 2 points). Based on the 10-point anchored visual analogue scale, 73% of treatments were successful (median improvement 3 points). Forty-eight patients (80%) responded favourably to the treatment. Side-effects were mild and transient. Dysphagia occurred in 9% of treatments. Antibody production was investigated in 41 patients and was negative in all. A striking difference from previous reports is the lower dosage used in this study. The clinical response, however, was similar to that of other studies. We conclude that a dosage of 200-400 mouse units BTA (Dysport) may also be effective in the treatment of cervical dystonia, but with fewer side effects. EMG guidance and application of BTA into deep cervical muscles may further improve the clinical effect.
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- 1995
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