NCT05121311

Brief Summary

Due to actual standard of neonatal care bilirubin is monitored in neonates several times after birth to avoid hyperbilirubinemia. As the peak is often one or two days after discharge from hospital a more precise predication than the actual one is desirable to avoid needlessly follow-ups. The precision of an algorithm to predict bilirubin values 24-48h into the future is evaluated in this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
455

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 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

August 9, 2021

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 16, 2021

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

May 3, 2022

Status Verified

May 1, 2022

Enrollment Period

4 months

First QC Date

August 18, 2021

Last Update Submit

May 2, 2022

Conditions

Newborn Jaundice

Keywords

newborn jaundiceHyperbilirubinaemia

Outcome Measures

Primary Outcomes (1)

  • Precision of predicted bilirubin value

    Precision of the bilirubin value calculated by the NeoprediX B1 algorithm compared to the value measured by the center

    8 hours to 144 hours after birth

Study Arms (1)

Newborns under bilirubin monitoring

Bilirubin monitoring according to standard of care of the participating center

Diagnostic Test: NeoprediX B1 algorithm

Interventions

NeoprediX B1 algorithmDIAGNOSTIC_TEST

Re-assessement of bilirubin measurements done according to standard of care of the participating center by the NeoprediX B1 algorithm

Newborns under bilirubin monitoring

Eligibility Criteria

AgeUp to 72 Hours
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Newborn infants

You may qualify if:

  • Newborn infant
  • gestational age at birth ≥ 34+0/7 weeks

You may not qualify if:

  • Birth weight \< 1500g
  • Gestational age at birth \> 42+6/7 weeks
  • Genetically defined syndrome
  • Severe congenital malformation adversely affecting life expectancy or admission for a priori planned palliative care
  • Parents not fluent in German

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

KUNO Kinderklinik St. Hedwig

Regensburg, 93049, Germany

Location

University Children's Hospital

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Jaundice, NeonatalHyperbilirubinemia

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, NeonatalInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Axel Franz, Prof.

    University Children's Hospital Tübingen

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 18, 2021

First Posted

November 16, 2021

Study Start

August 9, 2021

Primary Completion

November 30, 2021

Study Completion

January 31, 2022

Last Updated

May 3, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)