NCT04714775

Brief Summary

Follow-up of participants of BANON1 study at age of at least 2 years. BANON1 (ClinicalTrials.gov ID: NCT03357250): Validation of biomarkers based on 24 months neuro-developmental outcome data 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 and a preliminary human study.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

Typical duration for all trials

Geographic Reach
2 countries

13 active sites

Status
unknown

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

February 5, 2019

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 19, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

2.3 years

First QC Date

January 13, 2021

Last Update Submit

January 18, 2021

Conditions

Asphyxia Neonatorum

Keywords

BiomarkersAsphyxiaHypoxic ischemic encephalopathy

Outcome Measures

Primary Outcomes (4)

  • participants with normal neuro-developmental status

    all infants with normal neuro-developmental status

    up to 42 month age

  • participants with potentially abnormal neuro-developmental status

    All infants who do not fulfill outcomes 1, 3 or 4

    up to 42 month age

  • participants with abnormal neuro-developmental status - HIE

    Presence of adverse 2 years neuro-developmental outcome likely attributable to perinatal hypoxic-ischemic brain injury

    up to 42 month age

  • participants with abnormal neuro-developmental status - non-HIE

    Presence of adverse 2 years neuro-developmental outcome not attributable to perinatal hypoxic-ischemic brain injury

    up to 42 month age

Eligibility Criteria

Age22 Months - 48 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children, who had been enrolled in the BANON study immediately after birth because they had been suspected to be at risk for perinatal brain injury (hypoxic-ischemic encephalopathy, HIE) and/or evaluated for hypothermia therapy.

You may qualify if:

  • Infants previously enrolled in BANON study

You may not qualify if:

  • Missing valid written informed parental consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Städtisches Krankenhaus Aschaffenburg

Aschaffenburg, 63739, Germany

RECRUITING

Universitätsklinikum Carl Gustav Carus, Neonatologie

Dresden, 01307, Germany

RECRUITING

Uniklinik Essen

Essen, 45147, Germany

RECRUITING

Marienkrankenhaus

Hamburg, 22149, Germany

RECRUITING

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

RECRUITING

Städtisches Klinikum Karlsruhe, Klinik für Kinder- und Jugendmedizin

Karlsruhe, 76133, Germany

RECRUITING

Klinik für Kinder- und Jugendmedizin, Klinikum Dritter Orden,

München, 80638, Germany

RECRUITING

Universitäts Kinderkrankenhaus und Perinatal Zentrum

München, 81377, Germany

RECRUITING

Kinderklinik Dritter Orden

Passau, 94032, Germany

RECRUITING

Klinik St. Hedwig

Regensburg, 93049, Germany

RECRUITING

Universitätsklinikum Tübingen, Universiätsklinik für Kinder- u. Jugendmedizin

Tübingen, 72076, Germany

RECRUITING

Cukurova University Hospital

Adana, 01330, Turkey (Türkiye)

RECRUITING

University of Firat, Department of Pediatrics

Elâzığ, 23040, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Asphyxia NeonatorumAsphyxiaHypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDeathPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and InjuriesBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxia, BrainVascular DiseasesCardiovascular DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Ron Meyer

    InfanDx AG

    STUDY DIRECTOR

Central Study Contacts

Ron Meyer

CONTACT

+49 172 266 5552ron.meyer@infandx.com

Carola Steins-Rang, Dr.

CONTACT

+49 22129271405carola.steins-rang@infandx.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2021

First Posted

January 19, 2021

Study Start

February 5, 2019

Primary Completion

June 1, 2021

Study Completion

December 1, 2021

Last Updated

January 20, 2021

Record last verified: 2021-01

Locations

TU(2)DE(11)