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| ID | Type | Description | Link |
|---|---|---|---|
| ALLO-trial | Other Identifier | Dutch Consortium for Studies in Obstetrics and Gynaecology | |
| 2006-005796-18 | EudraCT Number | ||
| 170991001 | Other Grant/Funding Number | ZonMw | |
| NTR-1383 | Registry Identifier | Dutch Trial Register | |
| NL26516.000.09 | Other Identifier | The Central Committee on Research Involving Human Subjects (CCMO) |
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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
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A former study (submitted) in 32 severely asphyxiated infants participating in a randomized double blind study, in which early postnatal allopurinol or a placebo (within 4 hours after birth) was administered to reduce free radical formation and consequently reperfusion/reoxygenation injury to the newborn brain, showed an unaltered high mortality and no clinically relevant improvement in morbidity in infants treated with allopurinol. It was hypothesized that postnatal allopurinol treatment started too late to reduce reperfusion-induced free radical surge and that initiating allopurinol treatment of the fetus with (imminent) hypoxia already via the mother during labor will be more effective to reduce free radical-induced post-asphyxial brain damage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allopurinol | Experimental | 500 mg allopurinol/ 50 mL water for injection intravenously |
|
| Placebo | Placebo Comparator | 500 mg mannitol/50 mL water for injection intravenously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allopurinol sodium | Drug | Allopurinol sodium 500 mg / 50 mL, intravenously, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Free radical production and markers of neuronal damage | Up to 24 hours postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Developmental outcome | Up to 5 years of age | |
| Mortality | Up to 28 days postpartum | |
| Severe composite morbidity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank van Bel, Prof MD PhD | Wilhelmina Children's Hospital/UMC Utrecht | Study Director |
| Manon JN Benders, MD, PhD | UMC Utrecht | Principal Investigator |
| Jan B Derks, MD, PhD | UMC Utrecht | Principal Investigator |
| Joepe J Kaandorp, MD | UMC Utrecht | Principal Investigator |
| Gerard H Visser, MD, PhD | UMC Utrecht | Principal Investigator |
| Ben WJ Mol, MD, PhD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Principal Investigator |
| Carin MA Rademaker, PhD | Clinical Pharmacy, UMCU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilhelmina Children's Hospital/UMC Utrecht | Utrecht | Utrecht | 3508AB | Netherlands | ||
| Jeroen Bosch Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20167117 | Background | 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, Derks JB. Antenatal allopurinol for reduction of birth asphyxia induced brain damage (ALLO-Trial); a randomized double blind placebo controlled multicenter study. BMC Pregnancy Childbirth. 2010 Feb 18;10:8. doi: 10.1186/1471-2393-10-8. | |
| 30138355 |
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| ID | Term |
|---|---|
| D005311 | Fetal Hypoxia |
| D015427 | Reperfusion Injury |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000493 | Allopurinol |
| D008353 | Mannitol |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Mannitol | Drug | Mannitol 500 mg/50 mL water for injection, intravenously, single dose |
|
| Up to 28 days postpartum |
| 's-Hertogenbosch |
| Netherlands |
| AMC | Amsterdam | Netherlands |
| VUmc | Amsterdam | Netherlands |
| Gelre hospitals | Apeldoorn | Netherlands |
| Groene Hart Hospital | Gouda | Netherlands |
| UMCG | Groningen | Netherlands |
| LUMC | Leiden | Netherlands |
| Maastricht University Medical Center | Maastricht | Netherlands |
| Diakonessenhuis | Utrecht | Netherlands |
| Maxima Medical Center | Veldhoven | Netherlands |
| Derived |
| Klumper J, Kaandorp JJ, Schuit E, Groenendaal F, Koopman-Esseboom C, Mulder EJH, Van Bel F, Benders MJNL, Mol BWJ, van Elburg RM, Bos AF, Derks JB; ALLO-trial study group. Behavioral and neurodevelopmental outcome of children after maternal allopurinol administration during suspected fetal hypoxia: 5-year follow up of the ALLO-trial. PLoS One. 2018 Aug 23;13(8):e0201063. doi: 10.1371/journal.pone.0201063. eCollection 2018. |
| 25512466 | Derived | 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, Derks JB. Maternal allopurinol administration during suspected fetal hypoxia: a novel neuroprotective intervention? A multicentre randomised placebo controlled trial. Arch Dis Child Fetal Neonatal Ed. 2015 May;100(3):F216-23. doi: 10.1136/archdischild-2014-306769. Epub 2014 Dec 15. |
| 24352085 | Derived | Kaandorp JJ, van den Broek MP, Benders MJ, Oudijk MA, Porath MM, Bambang Oetomo S, Wouters MG, van Elburg R, Franssen MT, Bos AF, Mol BW, Visser GH, van Bel F, Rademaker CM, Derks JB; ALLO-trial Study Group. Rapid target allopurinol concentrations in the hypoxic fetus after maternal administration during labour. Arch Dis Child Fetal Neonatal Ed. 2014 Mar;99(2):F144-8. doi: 10.1136/archdischild-2013-304876. Epub 2013 Dec 18. |
| 19564319 | Derived | Torrance HL, Benders MJ, Derks JB, Rademaker CM, Bos AF, Van Den Berg P, Longini M, Buonocore G, Venegas M, Baquero H, Visser GH, Van Bel F. Maternal allopurinol during fetal hypoxia lowers cord blood levels of the brain injury marker S-100B. Pediatrics. 2009 Jul;124(1):350-7. doi: 10.1542/peds.2008-2228. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |