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CompletedNCT03357250Updated Jan 12, 2021

Biomarkers And Neurological Outcome in Neonates (BANON)

An observational study in Asphyxia Neonatorum, sponsored by Life Science Inkubator. Completed at 11 sites in Germany. Open to participants aged 0 Minutes to 90 Minutes, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-12.

Sponsored by Life Science Inkubator · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
553
Ages
0 Minutes to 90 Minutes
Sex
All
01

Study summary

Validation 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 and a preliminary human study.

Read the detailed description

The aim of the study is to validate 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, and where the combination of laboratory parameters is derived from a preliminary study performed in Turkey (AAMBI) using a metabolomics approach.

02

Conditions studied

  • Asphyxia Neonatorum

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Keywords

  • biomarkers
03

In context

Asphyxia Neonatorum

106 studies on the registry are indexed under Asphyxia Neonatorum; 19 are open to participants now.

This study's enrollment of 553 is above the median of 200 across 27 observational studies indexed under Asphyxia Neonatorum.

Browse Asphyxia Neonatorum studies →

Lead sponsor

Life Science Inkubator is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Minutes to 90 Minutes
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Infants at risk for perinatal hypoxic-ischemic brain injury

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Need for resuscitation after birth: For >1 min. after birth, positive pressure respiratory support with face mask or endotracheal tube (but not only CPAP), or cardiac compressions
  • 5 min APGAR-score ≤ 5.
  • Perinatal hypoxia-ischemia defined as a perinatal acidosis indicated by a pH≤7.1 in arterial umbilical cord blood or early postnatal blood collected at \<30min of age
  • Perinatal hypoxia-ischemia indicated by a base deficit ≥ 12mmol/l in umbilical cord blood or early postnatal blood collected at \<30min of age.

Exclusion criteria

Exclusion Criteria:

  • Age >1.5h
  • gestational age \< 36 weeks
  • birth weight \<2000g
  • congenital malformation
  • missing valid written informed parental consent
  • unsuccessful resuscitation
  • infant considered not-viable
  • decision for palliative care only
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
553 participants (actual)
Target follow-up
14 Days
Patient registry
Yes
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. Validation of diagnostic algorithm

    The best combinations of biomarkers from the preliminary study will be used and sensitivity and specificity as well as positive and negative likelihood ratios and their 95%-confidence limits will be calculated.

    Time frame: 10 days

07

Study locations

11 sites
  • Abt. Neonatologie und Päd. Intensivmedizin Klinikum
    Aschaffenburg, 63739, Germany
  • Neonatologie Universitätsklinikum
    Dresden, 01307, Germany
  • Universitätsklinikum Essen Klinik für Kinderheilkunde I Neonatologie
    Essen, 45147, Germany
  • Marienkrankenhaus im Wilhelmstift
    Hamburg, 22087, Germany
  • Universitätsklinikum Heidelberg Neonatologie
    Heidelberg, 69120, Germany
  • Klinik für Kinder- und Jugendmedizin
    Karlsruhe, 76133, Germany
  • Klinik für Kinder- und Jugendmedizin, Klinikum Dritter Orden
    München, 80638, Germany
  • Haunersches Kinderspital am Perinatalzentrum Grosshadern
    München, 81377, Germany
  • Kinderklinik Dritter Orden
    Passau, 94032, Germany
  • Klinik St. Hedwig Neonatologie
    Regensburg, 93049, Germany
  • Klinik für Kinder und Jugendmedizin
    Tübingen, 72070, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2016 to primary completion in Jun 2019, 33 months.

Of 16 observational studies under Asphyxia Neonatorum, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 47. This study's 33 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 24, 2017
First posted
Nov 29, 2017
StartActual
Sep 2016
Primary completionActual
Jun 2019
CompletionActual
Jun 2019
Last update
Jan 12, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03357250
Lead sponsor
Life Science Inkubator
Collaborators
University Hospital Tuebingen
Responsible party
Sponsor
First posted
Nov 29, 2017
Start date
Sep 2016
Primary completion
Jun 2019
Completion
Jun 2019
Last update
Jan 12, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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