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Perinatal allopurinol trial for reduction of birth asphyxia induced brain damage.

Does antenatal allopurinol during asphyxia reduce post-hypoxic-ischemic reperfusion damage in the newborn?

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28692
Enrollment
220
Registered
2008-07-16
Start date
2009-01-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

perinatal asphyxia, neuroprotection, allopurinol, newborn, oxidative stress

Interventions

Randomized, double blind controlled allopuirnol (500mg iv) or placebo as soon as fetal hypoxia is imminent

Sponsors

Prof dr. F. van Bel
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Gestational age of 36 weeks or more, determined by maternal dates and/or Ballard score. 2. Objective fetal hypoxia registered by: - Abnormalities on STAN S21 fetal electrocardiography monitor (Neoventa Medical, Gothenborg, Sweden). A fetal scalp electrode is allocated to the parturient for continuous internal cardiotocographic recordings combined with the computer for fetal heart monitor for ST analysis of the fetal electrocardiogram signals, which are stored automatically in digital form OR - non-reassuring CTG - Fetal blood sampling: pH<7.20 3. Informed consent given by patient.

Exclusion criteria

Exclusion criteria: 1. Congenital, chromosomal or syndromal malformations.

Design outcomes

Primary

MeasureTime frame
The brain damage marker S100B and the severity of oxidative stress measured in umbilical cord blood and neonatal blood (isoprostane, neuroprostane, non protein bound iron).

Secondary

MeasureTime frame
Neonatal mortality and serious composite morbidity.

Contacts

Public ContactM.J.N.L. Benders

Universitair Medisch Centrum Utrecht Lokatie Wilhelmina Kinderziekenhuis (WKZ) KE 04.123.1 Postbus 85090

m.benders@umcutrecht.nl+31 (0)88 7554545

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)