Better assessment of neonatal jaundice at home (BEAT jaundice @ home)
Recruiting
- Conditions
- jaundiceNeonatal hyperbilirubinaemia1001965410028920
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 2310
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
• 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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome of the study is the added value of universal TcB screening<br /><br>compared to only visual inspection to detect neonatal hyperbilirubinaemia<br /><br>requiring treatment, while decreasing the need for heel pricks to quantify<br /><br>total bilirubin in blood.<br /><br>As such, the study has two primary endpoints, assessed at each time point for<br /><br>each newborn in the study: 1. LBB above the treatment threshold; 2. Need for a<br /><br>heelprick (to determine LBB).</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Diagnostic properties of Bilistick®.<br /><br>• Difference in time-to-test result between LBB and Bilistick® (in minutes).<br /><br>• Difference in blood volume between LBB and Bilistick® (in µl).<br /><br>• Diagnostic properties of Picterus® app vs. TcB and LBB.<br /><br>• Added value of Picterus® app compared to only visual inspection in picking up<br /><br>neonates with hyperbilirubinaemia requiring treatment, while reducing the need<br /><br>for heel pricks to quantify bilirubin in blood.<br /><br>• Potential cost-effectiveness of implementation of the novel methods in daily<br /><br>practice.<br /><br>• Proportion of neonates receiving phototherapy.<br /><br>• Proportion of neonates having a LBB level above the phototherapy threshold.<br /><br>• Proportion of neonates having a LBB level above the exchange transfusion<br /><br>threshold.<br /><br>• Proportion of neonates who actually received an exchange transfusion.</p><br>