It is notoriously difficult to conduct studies with cohorts of young children and their caregivers due to participant burden and subjectivity in patient-reported outcomes. This fully virtual study, the first of its kind targeting infants and caregivers, will leverage digital instruments and AI to capture and quantify infant cries as a key outcome for colic symptoms and quality-of-life endpoints. Throughout the trial, the goal is to use technology-enabled processes to maximize data accuracy while minimizing caregiver burden.
To measure and evaluate colic symptoms in breastfed infants consuming a specialized product.
Study product will be shipped to caregiver participants along with an infant-specific audio recording device. Participants will download the ObvioHealth app on their own devices. The app includes user-friendly training modules explaining how to use the audio capture function to ensure infant cries are properly recorded and uploaded. In parallel, caregivers will report frequency and duration of crying via eDiary within the app.
Unstructured audio data will be analyzed via an algorithm to measure cry duration. Collected data will be assessed against baseline to gauge reductions in crying and fussing incidents. Throughout the trial, the virtual study, or COACH (Clinical Oversight And Coordination Hub), team will monitor reported changes to the infants’ health status and assess eDiary data in real-time for potential adverse events. They will also be available to address any participant questions or concerns.