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ID
Source
Brief title
Health condition
Neonatal jaundice; neonatal hyperbilirubinemia; neonatal hyperbilirubinaemia; neonatale geelzucht; neonatale hyperbilirubinemie; neonatale icterus
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is to assess whether universal TcB screening can increase the detection of neonates with hyperbilirubinaemia necessitating treatment compared to using only visual inspection, and at the same time decrease the number of heel pricks performed to quantify total bilirubin in blood. As such, there are two primary endpoints assessed at each time point for each neonate:
(1) LBB above the treatment threshold
(2) the need for a heel prick to determine LBB.
Secondary outcome
1. Diagnostic properties and effectiveness of TcB
1.1 Added value of TcB compared to only visual inspection in picking up neonates with hyperbilirubinemia requiring treatment, while reducing the need for heel pricks to quantify bilirubin in blood
1.2 TcB versus LBB
2. Diagnostic properties and effectiveness of Picterus®
2.1 Added value of Picterus® app compared to only visual inspection in picking up neonates with hyperbilirubinemia requiring treatment, while reducing the need for heel pricks to quantify bilirubin in blood
2.2 Picterus® app versus LBB
2.3 Picterus® app versus TcB
2.4 Added value of combining TcB and Picterus®
3. Diagnostic properties and effecteviness of Bilistick®
3.1 Bilistick® versus LBB
3.2 Difference in time-to-test result between LBB and Bilistick®
4. Proportion of neonates receiving phototherapy
5. Proportion of neonates having a LBB level above the phototherapy threshold
6. Proportion of neonates having a LBB level above the exchange transfusion threshold
7. Proportion of neonates who actually received an exchange transfusion
8. Potential cost-effectiveness of implementation of the novel methods in daily practice
9. User-convenience of TcB, Picterus® and Bilistick®
10. Experience of parents
Background summary
Severely elevated bilirubin levels can place a neonate at risk for permanent brain damage, acute bilirubin encephalopathy or – on the long term – kern icterus spectrum disorder. Therefore, early diagnosis of severe neonatal hyperbilirubinemia (SNH) is essential to prevent these deleterious sequelae. Although known to be unreliable, visual inspection followed by selective laboratory-based bilirubin (LBB) quantification remains the current standard to prevent SNH in neonates cared for at home in the Netherlands. We aim to evaluate the effectiveness, diagnostic properties and cost-effectiveness of three novel approaches for screening and diagnosing neonatal hyperbilirubinemia in the home setting: transcutaneous bilirubinometer (TcB; Draeger JM-105), a smartphone app (Picterus®) and a point-of-care device for quantifying total bilirubin (Bilistick®).
Study objective
We hypothesise that among well neonates cared for at home during day 2-8 of life:
1. Universal TcB screening will improve recognition of neonates having hyperbilirubinaemia requiring treatment compared to visual inspection, while decreasing the need for heel pricks to quantify bilirubin in blood in case of suspected hyperbilirubinaemia.
2. The Picterus® app correlates well with TcB and laboratory-based bilirubin (LBB)levels and use of the Picterus® app will improve recognition of neonates having hyperbilirubinaemia necessitating treatment compared to visual inspection, while decreasing the need for heel pricks to quantify LBB.
3. In neonates requiring bilirubin quantification in blood, Bilistick® will have similar total bilirubin readings compared to LBB quantification, while reducing the time-to-test result to determine total bilirubin in blood.
Study design
The primary outcomes and the secondary outcomes will be defined within the first 14 days of life of the neonate.
Intervention
1. Transcutaneous bilirubinometer (TcB; Draeger JM-105): a non-invasive method for estimating total bilirubin in blood
2. Picterus® app: a smartphone app which screens for neonatal jaundice using a photograph taken by a smartphone
3. Bilistick®: a commercially available point-of-care test for total bilirubin in whole blood
Inclusion criteria
Neonates are considered eligible for inclusion if they:
- are born at a gestational age of at least 35 weeks
- are cared for at home during day 2-8 of life
- have their first midwife visit at home prior to day 6
Exclusion criteria
Neonates are not considered eligible if they:
- previously received phototherapy
- Parents who have no sufficient understanding of the Dutch language to be able to understand the patient information sheet
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9545 |
| CCMO | NL74483.078.20 |
| OMON | NL-OMON55110 |