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OpenTrials
Completed

NCT Number: NCT05121311

Assessment of Neonatal Hyperbilirubinemia by NeoprediX B.1 Algorithm

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.

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Key information

Age range

Up to 72 hour

Sex eligibility

All sexes

Study type

Observational

Primary location

KUNO Kinderklinik St. Hedwig, Regensburg, Germany

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NeoprediX B1 algorithm

Diagnostic Test

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

Primary outcomes

  1. Precision of predicted bilirubin value

    Time frame: 8 hours to 144 hours after birth

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

Sponsors and collaborators

Lead sponsor

NeoPredix AG

Industry

Collaborators

  • Center for Pediatric Clinical Studies (CPCS)

Registry information

Official study title

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

Acronym: Bili-PrediX1

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Nov 16, 2021
Registry last updated
May 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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