NCT03354208

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 27, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2017

Completed
Last Updated

January 12, 2021

Status Verified

January 1, 2021

Enrollment Period

1.2 years

First QC Date

September 22, 2017

Last Update Submit

January 9, 2021

Conditions

Asphyxia Neonatorum

Keywords

biomarkers

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Group 1

patients with hypoxic-ischemic encephalopathy (HIE) receiving hypothermia therapy

Other: blood sampling

Group 2

patients with suspected HIE, non-confirmed

Other: blood sampling

Group 3

healthy, retrospectively classified as such

Other: blood sampling

Interventions

blood samplingOTHER

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

Group 1Group 2Group 3

Eligibility Criteria

Age0 Hours - 2 Hours
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Infants at risk for perinatal hypoxic-ischemic brain injury

You may qualify if:

  • 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)
  • min 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Cukurova University

Adana, 01330, Turkey (Türkiye)

Location

University of Firat

Elâzığ, Turkey (Türkiye)

Location

Özel Güngören Hastanesi

Istanbul, 34164, Turkey (Türkiye)

Location

Mersin University School of Medicine

Mersin, 33343, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood plasma

MeSH Terms

Conditions

Asphyxia Neonatorum

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Ron Meyer

    Life Science Inkubator Betriebs GmbH & Co. KG

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
14 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2017

First Posted

November 27, 2017

Study Start

October 1, 2016

Primary Completion

December 27, 2017

Study Completion

December 27, 2017

Last Updated

January 12, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(4)