Hyperbilirubimenia, neonatal jaundice
Conditions
Interventions
The device
To use Picterus JP a user must place the calibration card on a neonate's exposed chest and take six consecutive photos with the app. These images, together with relevant newborn information
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
No minimum to 64 Years
Inclusion criteria
Inclusion criteria: Neonate - (Near)term born, i.e., a neonate with a gestational age of at least 35 weeks - Birthweight of 2000 grams or more - Cared for at home or maternity hotel between day 1 (=24 hours) and 7 of life (=144 hours) Parent - Participating parents have le-gal guardianship of the neo-nate and have sign informed consent for neonate and them-selves. - A smartphone compatible with the Picterus JP and platform (including an active internet connection). Health care provider - Certified HCP (e.g., paediatricians, midwives, maternity care assistants, nurses) and study team members. - Involved in neonatal care and/or screening and/ or diagnosis of hyperbilirubinemia at the study locations. - Used Picterus platform - Has given informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: Neonate - Received or required phototherapy within the first 24 hours of life. Or requiring frequent TSB measurements due to antenatally diagnosed blood-group-incompatibility. - Any underlying condition that may affect the intended use of the Picterus JP (e.g., bruises, rashes, or birthmarks on the chest). - Hospitalization within the first week of life that prevents parents from acting as the neonate’s primary caregivers. Admissions for phototherapy after 24 hours of life are not considered an exclusion criterion, since those data are collected as part of the study. Parent - Incomplete informed consent forms, where not all individuals with legal guardianship of the neonate have signed. - Parents are unable to understand the informed consent form due to insufficient comprehension of the available translations, even with the help of an oral translator Either parents or neonate does not fulfil inclusion requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Screening reliability of the Picterus JP used by parents compared to visual inspection, and TcB (i.e., standard care) performed by study team and/or HCP. a) The likelihood ratio b) Sensitivity, specificity c) Proportion of true- and false positive and true- and false negative referrals for TSB measurement.Feasibility of the Picterus platform evaluated by the median Likert score of a validated (MAUQ-like) questionnaire as scored by HCPs. | — |
Secondary
| Measure | Time frame |
|---|---|
| Screening reliability of the Picterus JP 1) Bland Altman analysis of PaB, and TcB and, when available, TSB (i.e., golden standard). a. Level of agreement b. Limits of relevance set at +/- 50 2) The proportion of heel pricks (blood tests) performed to quantify TSB based on Picterus JP and TcB bilirubin estimates, as defined by the following thresholds: a. PaB above SNH-threshold (defined as halfway between PT and ET threshold b. TcB +50 above PT-threshold Feasibility and user acceptance of the Picterus platform, including the Picterus JP, among parents and HCPs 1)User barriers a. Proportion of families unable to use Picterus JP. Identified reasons for non-usage, including smartphone in-compatibility, network accessibility issues, or other systemic constraints. b. Proportion of errors when using the app c. Proportion of measurements forgotten to take (without reminder by study team or HCP) 2) Parental User Experience a. Questionnaire with open ended questions evaluating satisfaction, perceived ease of use and confidence in Picterus JP. 3) HCP User Experience a. Compare number of clinical visits related to neonatal jaundice based on PaB versus standard care by HCP which can include visual in-spection and/or the use of TcB. b. Evaluating impact on workload and management of jaundice care with Picterus platform recommendations through a questionnaire with open-ended questions and a focus group. | — |
Countries
Netherlands
Contacts
Public ContactF.J. Terpstra
Universitair Medisch Centrum Groningen
Outcome results
None listed