NCT03357250

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
553

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Geographic Reach
1 country

11 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

September 1, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 29, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

January 12, 2021

Status Verified

November 1, 2020

Enrollment Period

2.7 years

First QC Date

November 24, 2017

Last Update Submit

January 9, 2021

Conditions

Asphyxia Neonatorum

Keywords

biomarkers

Outcome Measures

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.

    10 days

Eligibility Criteria

Age0 Minutes - 90 Minutes
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:

  • 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
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Abt. Neonatologie und Päd. Intensivmedizin Klinikum

Aschaffenburg, 63739, Germany

Location

Neonatologie Universitätsklinikum

Dresden, 01307, Germany

Location

Universitätsklinikum Essen Klinik für Kinderheilkunde I Neonatologie

Essen, 45147, Germany

Location

Marienkrankenhaus im Wilhelmstift

Hamburg, 22087, Germany

Location

Universitätsklinikum Heidelberg Neonatologie

Heidelberg, 69120, Germany

Location

Klinik für Kinder- und Jugendmedizin

Karlsruhe, 76133, Germany

Location

Klinik für Kinder- und Jugendmedizin, Klinikum Dritter Orden

München, 80638, Germany

Location

Haunersches Kinderspital am Perinatalzentrum Grosshadern

München, 81377, Germany

Location

Kinderklinik Dritter Orden

Passau, 94032, Germany

Location

Klinik St. Hedwig Neonatologie

Regensburg, 93049, Germany

Location

Klinik für Kinder und Jugendmedizin

Tübingen, 72070, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood plasma

MeSH Terms

Conditions

Asphyxia Neonatorum

Condition Hierarchy (Ancestors)

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

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

November 24, 2017

First Posted

November 29, 2017

Study Start

September 1, 2016

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

January 12, 2021

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(11)