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Biomarkers and Asphyxia

Biomarkers and Asphyxia - Biomarkers and asphyxia

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON35285
Enrollment
280
Registered
2011-07-05
Start date
2011-11-18
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

hypoxic-ischaemic encephalopathy oxygen depreviation perinatal asphyxia

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

Inclusion criteria: Gestational age of at least 37 weeks and two of the following criteria: - Signs of fetal distress: late decelerations or decreased variability of fetal heart rate on cardiotocography, or meconium stained amnion fluid, or fetal scalp blood ph 5 minutes - Multi-organ failure

Exclusion criteria

Exclusion criteria: - Congenital malformations - Documented chromosomal abnormalities - Inherited errors of metabolism

Design outcomes

Primary

MeasureTime frame
Measurement of concentrations of oxidative stress parameters (NPBI, 8-isoprostane) and neuro-biomarkers (S100B, NSE and B-FABP) in cord blood, arterial blood at 0-6, 72, 108 hours and in saliva and urine at 0-6, 8, 12, 16, 20, 24, 36, 48, 72, 96 en 108 hours after birth. Outcome measurements for hypoxic ischemic brain injury are brain injury on MRI (day 3-5) or neonatal mortality.

Secondary

MeasureTime frame
Outcome measurements for adverse long-term outcome are neurodevelopmental abnormalities at 18 months and 5 years of follow-up.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)