Reperfusion Injury Clinical Trial
Official title:
Does Antenatal Allopurinol Administration Reduce Post-hypoxic-ischemic Reperfusion Damage During Fetal Hypoxia in the Newborn?
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.
Status | Active, not recruiting |
Enrollment | 222 |
Est. completion date | December 2016 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Gestational age of 36 weeks or more - Non-reassuring CTG, significant events on the STAN-monitor AND/OR FBS < 7.20 Exclusion Criteria: - Chromosomal abnormalities |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | AMC | Amsterdam | |
Netherlands | VUmc | Amsterdam | |
Netherlands | Gelre hospitals | Apeldoorn | |
Netherlands | Jeroen Bosch Hospital | Den Bosch | |
Netherlands | Groene Hart Hospital | Gouda | |
Netherlands | UMCG | Groningen | |
Netherlands | LUMC | Leiden | |
Netherlands | Maastricht University Medical Center | Maastricht | |
Netherlands | Diakonessenhuis | Utrecht | |
Netherlands | Wilhelmina Children's Hospital/UMC Utrecht | Utrecht | |
Netherlands | Maxima Medical Center | Veldhoven |
Lead Sponsor | Collaborator |
---|---|
UMC Utrecht | ZonMw: The Netherlands Organisation for Health Research and Development |
Netherlands,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Free radical production and markers of neuronal damage | Up to 24 hours postpartum | No | |
Secondary | Developmental outcome | Up to 5 years of age | No | |
Secondary | Mortality | Up to 28 days postpartum | Yes | |
Secondary | Severe composite morbidity | Up to 28 days postpartum | Yes |
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