Assessment of Neonatal Hyperbilirubinemia by NeoprediX B.1 Algorithm (Bili-PrediX1)

Assessment of Neonatal Hyperbilirubinemia by NeoprediX B.1 Algorithm - Prospective Observational Study -

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.

Study Overview

• Status: Completed
• Conditions: Newborn Jaundice
• Intervention / Treatment: Diagnostic test: NeoprediX B1 algorithm

Detailed Description

Neonatal jaundice is common and mostly transient without need for intervention. To identify infants at risk of bilirubin toxicity, bilirubin is measured several times after birth and before discharge home. As the peak bilirubin concentrations are reached at days 4-6 after birth, and most infants are discharged home around 48 hours after birth, parents are often asked to return to hospital one or two days after discharge with their newborn baby to have the bilirubin value checked in order to prevent that hyperbilirubinemia requiring treatment is not missed. A precise prediction of the course of bilirubin values based on the measurements done during the initial hospital stay after birth would be desirable to avoid unnecessary follow ups (both for the families and the health care system).

This study aims to evaluate the precision of the NeoprediX B1 algorithm. This algorithm predicts bilirubin values 24-48h into the future based on preceding values and some clinical variables. Five different scenarios will be explored, differing in the type, number and timepoints of measurements used for the prediction as well as the timepoint that is to be predicted.

• Study Type: Observational
• Enrollment (Actual): 455

Contacts and Locations

Study Locations

• Germany
  • Regensburg, Germany, 93049
    • KUNO Kinderklinik St. Hedwig
  • Tübingen, Germany, 72076
    • University Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 days (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Newborn infants

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Newborns under bilirubin monitoring; Bilirubin monitoring according to standard of care of the participating center	Diagnostic test: NeoprediX B1 algorithm; Re-assessement of bilirubin measurements done according to standard of care of the participating center by the NeoprediX B1 algorithm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: NeoPredix AG
• Collaborators: Center for Pediatric Clinical Studies (CPCS)
• Investigators: Principal Investigator: Axel Franz, Prof., University Children's Hospital Tübingen

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2021
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: August 18, 2021
• First Submitted That Met QC Criteria: November 15, 2021
• First Posted (Actual): November 16, 2021

Study Record Updates

• Last Update Posted (Actual): May 3, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: newborn jaundice; Hyperbilirubinaemia
• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Skin Manifestations; Jaundice; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal; Jaundice, Neonatal
• Other Study ID Numbers: 507/2021B02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No