Better assessment of neonatal jaundice at home (BEAT jaundice @ home)

Better assessment of neonatal jaundice at home (BEAT jaundice @ home) - BEAT jaundice @ home

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55110

Enrollment

2310

Registered

2021-05-21

Start date

2021-07-11

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

jaundice Neonatal hyperbilirubinaemia

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: • Born at a gestational age of at least 35 weeks. • Cared for at home between day 2 and 8 of life. • Having a first midwife visit at home prior to day 6. • Written informed consent according to the national guidelines of both parents or legal representatives. Given the low risks of participating in the study, referred consent of the second parent is allowed as well.

Exclusion criteria

Exclusion criteria: • The neonate previously received phototherapy (as reliability of TcB measurement is reduced in neonates who have received phototherapy). • The neonate has parents who do not have sufficient understanding of the Dutch language to be able to comprehend the patient information sheet.

Design outcomes

Secondary

Measure	Time frame
• Diagnostic properties of Bilistick®. • Difference in time-to-test result between LBB and Bilistick® (in minutes). • Difference in blood volume between LBB and Bilistick® (in µl). • Diagnostic properties of Picterus® app vs. TcB and LBB. • Added value of Picterus® app compared to only visual inspection in picking up neonates with hyperbilirubinaemia requiring treatment, while reducing the need for heel pricks to quantify bilirubin in blood. • Potential cost-effectiveness of implementation of the novel methods in daily practice. • Proportion of neonates receiving phototherapy. • Proportion of neonates having a LBB level above the phototherapy threshold. • Proportion of neonates having a LBB level above the exchange transfusion threshold. • Proportion of neonates who actually received an exchange transfusion.	—

Measure

Time frame

• Diagnostic properties of Bilistick®. • Difference in time-to-test result between LBB and Bilistick® (in minutes). • Difference in blood volume between LBB and Bilistick® (in µl). • Diagnostic properties of Picterus® app vs. TcB and LBB. • Added value of Picterus® app compared to only visual inspection in picking up neonates with hyperbilirubinaemia requiring treatment, while reducing the need for heel pricks to quantify bilirubin in blood. • Potential cost-effectiveness of implementation of the novel methods in daily practice. • Proportion of neonates receiving phototherapy. • Proportion of neonates having a LBB level above the phototherapy threshold. • Proportion of neonates having a LBB level above the exchange transfusion threshold. • Proportion of neonates who actually received an exchange transfusion.

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Primary

Measure	Time frame
The primary outcome of the study is the added value of universal TcB screening compared to only visual inspection to detect neonatal hyperbilirubinaemia requiring treatment, while decreasing the need for heel pricks to quantify total bilirubin in blood. As such, the study has two primary endpoints, assessed at each time point for each newborn in the study: 1. LBB above the treatment threshold; 2. Need for a heelprick (to determine LBB).	—

Measure

Time frame

The primary outcome of the study is the added value of universal TcB screening compared to only visual inspection to detect neonatal hyperbilirubinaemia requiring treatment, while decreasing the need for heel pricks to quantify total bilirubin in blood. As such, the study has two primary endpoints, assessed at each time point for each newborn in the study: 1. LBB above the treatment threshold; 2. Need for a heelprick (to determine LBB).

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Countries

Netherlands

Outcome results