Congenital Heart Disease in Children

Neuroprotection

Allopurinol powder for solution for infusion (PFI) 20 mg/kg body weight per administration will be administered early postnatally (within 45 minutes and 12 hours after the first dose), preoperatively (12 hours before surgery), intraoperatively (during surgery) and postoperatively (24 hours after surgery) to the neonate in case of a prenatal CCHD diagnosis. Allopurinol PFI will be administered only pre-, intra- and postoperatively to the neonate in case of a postnatal CCHD diagnosis.

Allopurinol

Mannitol powder for solution (PFI) placebo will be administered early postnatally (within 45 minutes and 12 hours after birth), preoperatively (12 hours before surgery), intraoperatively (during surgery), and postoperatively (24 hours after surgery) to the neonate in case of a prenatal CCHD diagnosis. Mannitol PFI-placebo will be administered only pre-, intra- and postoperatively to the neonate in case of a postnatal CCHD diagnosis.

Mannitol

VU University Medical Center (VUmc)

Academic Medical Center (AMC)

University Medical Center Groningen (UMCG)

Leiden University Medical Center (LUMC)

Radboud University Medical Center Nijmegen (Radboudumc)

Erasmus Medical Center Rotterdam (Erasmus MC)

University Medical Center Utrecht (UMC Utrecht)

Cerebrum and Cardiac Protection With Allopurinol in Neonates With Critical Congenital Heart Disease Requiring Cardiac Surgery With Cardiopulmonary Bypass

The presence or absence of relevant (moderate/severe) parenchymatous (ischemic or hemorrhagic) brain injury on postoperative MRI will be assessed, using the T1/T2/DWI and SWI weighted images.

This decision is based on the circulatory and respiratory status of the child before the planned postoperative MRI, as included in local guidelines (not part of this protocol) of each participating center.

Defined as death until one month postoperatively.

An MRI score, which includes diffusion-weighted imaging as well as assessment of the deep grey matter, white matter, and cerebellum [Weeke L, et al. J Pediatr 2018]. The score will be compared between groups (allopurinol vs placebo).

To assess whether there are differences between groups (allopurinol vs placebo) in volume (mm3) of hypoxic-ischemic brain lesions using a fully automatic method for detection and quantification of ischemic lesions in diffusion-weighted MR images [Murphy K, et al. Neuroimage Clin 2017].

Video recordings will be analyzed following the global general movement categories (normal, poor repertoire, cramped-synchronized, or chaotic) and the motor optimality score [Einspieler C, et al. Dev Med Child Neurol. 2016]. A higher score expresses a more optimal performance. Scores will be compared between groups (allopurinol vs placebo).

To assess motor, cognitive, speech and language development using the Bayley Scales of Infant and Toddler Development - Third Edition - NL (Bayley-III-NL). An average Bayley-III-NL score is 100, one standard deviation (SD) above or below the mean concerns 15 points. Scores will be compared between groups (allopurinol vs placebo).

Both 'hot' executive functions (snack and gift delay tasks) and 'cool' executive functions (six boxes, memory for location, and visual search task) will be tested and scored. A higher score indicates a better performance. The results of the executive function tasks will be compared with healthy children from the PreCool study [Veen A, Veen I van der, Heurter AMH, et al. Pre-Cool cohortonderzoek, technisch rapport tweejarigen cohort. Amsterdam: Kohnstamm Instituut Rapport 877, Projectnummer 20379]. A higher score reflects a more optimal perfomance. Scores will be compared between groups (allopurinol vs placebo).

The TNO-AZL Questionnaire for Preschool Children's Health-Related Quality of Life (TAPQoL) will be assessed to give insight in the quality of life of both children with CCHD and their parents. A higher score indicates a better quality of life. Scores will be compared between groups (allopurinol vs placebo).

dr. M.J.N.L. Benders

Professor, Head of Neonatology, MD

ZonMw: The Netherlands Organisation for Health Research and Development

University Medical Center Groningen

Leiden University Medical Center

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

VU University Medical Center

Erasmus Medical Center

University Medical Center Nijmegen

ACE Pharmaceuticals BV

Patients were randomized to this arm will receive a bolus of N-acetylcysteine in an hour of 150 mg/kg after the beginning of the operation. After the bolus will start a 6-hour infusion of 50mg/kg/h of N-acetylcysteine.

Patients were randomized to this arm will receive a bolus of methylprednisolone in an hour of 500 mg after the beginning of the operation. After the bolus will start a 6-hour infusion of placebo (Ringer's acetate).

Patients were randomized to this arm will receive placebo (Ringer's acetate) in an hour after the beginning of the operation. After the bolus will start a 6-hour infusion of placebo (Ringer's acetate).

Ischemic Reperfusion Injury

Insufficiency; Hepatic, Postoperative

Liver Tumour

Methylprednisolone is a glucocorticoid, which is an adrenocortical steroid. The chemical name for methylprednisolone is pregna-1,4-diene-3,20-dione, 11,17,21-trihydroxy-6-methyl-, (6α,11β)-and the molecular weight is 374.48. It is an analog of naturally occurring glucocorticoid (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Methylprednisolone is used for their potent anti-inflammatory effects in disorders of many organ systems, it modify the body's immune responses to diverse stimuli. The usual dosage of medication varies in relation to pathology for which is prescribed: normally varies from about 40-60 mg per day up to very high doses of 30 mg/kg bolus as used in spinal cord injury.

Methylprednisolone

Acetylcysteine is the N-acetyl derivative of the naturally occurring amino acid, L-cysteine. Chemically, it is N-acetyl-L-cysteine. The compound is a white crystalline powder which melts at 104°-110°C and has a very slight odor. Acetylcysteine may form cysteine, disulfides, and conjugates in vivo (N, N'-diacetylcysteine, N-acetylcysteine- cysteine, N-acetylcysteine-glutathione, N-acetylcysteine-protein, etc). No metabolites were identified. Acetylcysteine likely protects the liver by maintaining or restoring the glutathione levels, or by acting as an alternate substrate for conjugation with, and thus detoxification of, the reactive metabolite.

N-acetylcysteine

Istituto Clinico Humanitas IRCCS

Methylprednisolone N Acetylcysteine in Hepatic Resections

Phase II Randomized Double Blind Trial of Methylprednisolone and N-acetylcysteine in Hepatic Resections.

The primary endpoint of the study is the modulation of the IR injury made by NAC and/or MET in patients undergoing liver surgery. For this purpose a decrease of 100 UI/L of AST and ALT is expected compared with placebo.

This secondary endpoint want to assess difference in total bilirubin expression between the intervention groups and the placebo group.

This secondary endpoint want to assess difference in blood transfusion between the intervention groups and the placebo group.

Istituto Clinico Humanitas

Anaesthesia

receive intravenous injection of 0.2 mL/kg of saline 0.9%L [group P]. All study solutions were injected within 1 min at T0 after discontinuation of sevoflurane. No stimulation was applied to patients during this period.

Placebo [group P]

receive intravenous injection of 0.2 mL/kg of aminophylline 10 mg/mL [group A2]. All study solutions were injected within 1 min at T0 after discontinuation of sevoflurane. No stimulation was applied to patients during this period.

0.2 mL/kg of aminophylline 10 mg/mL [group A2]

receive intravenous injection of 0.2 mL/kg of aminophylline 15 mg/mL [group A3]. All study solutions were injected within 1 min at T0 after discontinuation of sevoflurane. No stimulation was applied to patients during this period.

0.2 mL/kg of aminophylline 15 mg/mL [group A3]

receive intravenous injection of 0.2 mL/kg of aminophylline 20 mg/mL [group A4]. All study solutions were injected within 1 min at T0 after discontinuation of sevoflurane. No stimulation was applied to patients during this period.

0.2 mL/kg of aminophylline 20 mg/mL [group A4]

receive intravenous injection of 0.2 mL/kg of aminophylline 25 mg/mL [group A5]. All study solutions were injected within 1 min at T0 after discontinuation of sevoflurane. No stimulation was applied to patients during this period.

0.2 mL/kg of aminophylline 25 mg/mL [group A5]

receive intravenous injection of 0.2 mL/kg of doxapram 5 mg/mL [group D]. All study solutions were injected within 1 min at T0 after discontinuation of sevoflurane. No stimulation was applied to patients during this period.

Doxapram 1 mg/kg [group D]

King Faisal University

Aminophylline and Cognitive Function After Sevoflurane Anaesthesia

Aminophylline Improves Early Postoperative Cognitive Recovery After Sevoflurane Anaesthesia: A Dose-Dependent Study

The SOMCT is a patient-based test designed to assess cognitive function in terms of level of orientation, memory, and concentration.

Mohamed R. El-Tahan

Acute Mountain Sickness

Daily dose of 1g L-ascorbic acid, 400 IU of alpha-tocopherol acetate, and 600mg of alpha-lipoic acid in sealed capsules as anti-oxidant supplementation.

Anti-oxidant supplementation

Matched placebo for anti-oxidant supplementation

University of Edinburgh

Anti-Oxidant Supplementation for the Prevention of Acute Mountain Sickness

Randomized Double-Blind Placebo-Controlled Trial of Oral Anti-Oxidant Supplementation for the Prevention of Acute Mountain Sickness.

JK Baillie

Altitude Physiology Expeditions

Children with OSAS identified via sleep study

xanthine/hypoxia

Cerebrum and Cardiac Protection With Allopurinol in Neonates With Critical Congenital Heart Disease Requiring Cardiac Surgery With Cardiopulmonary Bypass

Methylprednisolone N Acetylcysteine in Hepatic Resections

Aminophylline and Cognitive Function After Sevoflurane Anaesthesia

Anti-Oxidant Supplementation for the Prevention of Acute Mountain Sickness

Hepatic Drug Biotransformation in Children With Obstructive Sleep Apnea

Vascular Pathophysiology in Obstructive Sleep Apnea

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