Biomarkers and Asphyxia

Completed

• Conditions: hypoxic-ischaemic encephalopathy; oxygen depreviation; perinatal asphyxia; 10014623; 10028920

• Registration Number: NL-OMON35285
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 280

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 < 7.2
- Apgar score <=5 at one minute or <= 7 at five minutes
- Arterial cord blood or first pH < 7,00
- Need for ventilation > 5 minutes
- Multi-organ failure

Exclusion Criteria

- Congenital malformations
- Documented chromosomal abnormalities
- Inherited errors of metabolism

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<p>Outcome measurements for adverse long-term outcome are neurodevelopmental<br /><br>abnormalities at 18 months and 5 years of follow-up. </p><br>