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NCT05630495
Validation of an Innovative Neonatal Jaundice Detection System (Picterus) in Indonesia
Conditions: Jaundice, Neonatal
Sex: All
Ages: 1 Day – 14 Days
Healthy volunteers: 1
Phase: NA
Enrollment: 150
Sponsor: Picterus AS
Summary
The long-term goal of this project is to establish Picterus as a permanent tool to detect NNJ in the healthcare services of Indonesia.
Offering early detection and therefore, timely treatment to NNJ, will substantially improve neonatal health and directly work towards the Sustainable Development Goal 3.2.2,
reduce neonatal mortality.
The study as the following specific subgoals:Demonstrate that Picterus system performs accurately in Indonesian newbornsEnsure that Picterus is in line with users' needs in Indonesia
Eligibility Criteria
Inclusion Criteria:- Infants born with gestational age ≥37 weeks Birth weight ≥2000g and ≤4500g Age 1 - 14 daysExclusion Criteria:- Infants transferred to the pediatric ward for advanced treatment.
Infants with a skin rash or other disease that affects the skin where measurements are performed.Infants that receive or have received phototherapy in the last 24 hours.
Infants with an inborn disease
Source: ClinicalTrials.gov (NCT05630495). StuddyBuddy aggregates publicly available trial information.