Asphyxia Associated Metabolite Biomarker Investigation (AAMBI)

Asphyxia Neonatorum Clinical Trial

— AAMBI  

Official title:

Verification of Biomarkers to Examine Neonatal Asphyxia Induced Hypoxic-ischemic Encephalopathy. A Prospective Multicenter Observational Study for Development of a Diagnostic Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03354208
• Other study ID #: AAMBI I
• Status: Completed
• Start date: October 2016
• Est. completion date: December 27, 2017

Study information

• Verified date: January 2021
• Source: Life Science Inkubator
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Verification of biomarkers in a human population for their ability to diagnose the severity of neonatal asphyxia. These biomarkers linked to asphyxia have been identified in animal studies.

Description:

The aim of the study is to verify the application of combinations of several laboratory parameters in early postnatal blood samples, for identification of infants, who will suffer from early abnormal neonatal neurological outcome, in a population at risk.

The population at risk is defined as term and late preterm (>36 weeks of gestation) human infants following perinatal hypoxia-ischemia with or without postnatal resuscitation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: December 27, 2017
• Est. primary completion date: December 27, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 2 Hours

Eligibility

Inclusion Criteria:

Group 1: inclusion criteria fulfilled for hypothermia treatment Group 2: Infants with suspected perinatal brain injury due to one of the followings

• Perinatal hypoxia-ischemia (defined as a perinatal acidosis indicated by a pH=7.10 or a base excess =-12mmol/l in umbilical cord blood or early postnatal blood collected at <90min of age (outborn patients)

• 5min APGAR-score = 5

• Need for resuscitation after birth for >1 min. after birth, positive pressure respiratory support with face mask or endotracheal tube, or cardiac compressions Group 3: UApH >7,25, and adaptation disorder of the newborn and need of postnatal clinical surveillance

Exclusion Criteria:

gestational age < 36 weeks

• age at time of screening >2,5h

• congenital malformation

• missing or invalid informed parental consent

• unsuccessful resuscitation

• infant considered not-viable

• decision for palliative care only

Related Conditions & MeSH terms

• Asphyxia
• Asphyxia Neonatorum

Intervention

Other:
• blood sampling
small volume blood sampling, according to local laws, is not categorized as intervention (observational study)

Locations

Country	Name	City	State
Turkey	Cukurova University	Adana
Turkey	University of Firat	Elazig
Turkey	Özel Güngören Hastanesi	Istanbul
Turkey	Mersin University School of Medicine	Mersin

Sponsors (3)

Lead Sponsor	Collaborator
Life Science Inkubator	Cukurova University, University Children's Hospital Tuebingen

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	abnormal short-term outcome (NE)	All patients are classified as abnormal short-term outcome (neonatal encephalopathy, NE) or normal short term outcome (no encephalopathy) by using clinical data, particularly Thompson score. For Group 1 and group 2 patients outcome classification will be additionally confirmed by using cranial ultrasound or MRI (including severe ischemia based on DWI or thalamic or cerebellar bleeding or arterial infarction or IVH>2° according to Papile, thalamic ischemia or severe cerebral edema) or seizure activity or burst suppression on aEEG or persistingly abnormal aEEG background pattern after complete rewarming.; Bloodplasma samples will be analysed by a metabolomics approach using the p180-kit (Biocrates, Innsbruck, Austria). Metabolite concentrations or combinations thereof will be compared to the outcome described above in order to identify the most suitable metabolites to be used for early detection of NE in newborn infants.	14 days for clinical diagnosis