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.
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.
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.
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.
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.
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.
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.
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.
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.
ObvioHealth successfully conducted a clinical trial for RedHill Biopharma to test the safety and efficacy of an oral medication for the treatment of COVID-19 symptoms. We designed this decentralized study to be conducted where the majority of patients recover from illness—in their homes. When the trial was launched in 2021, its unique combination of home health visits, electronic patient-reported outcomes (ePRO), and remote monitoring devices was pioneering—COVID-19 studies were typically conducted inside hospitals.
ObvioHealth and Renovia conducted a groundbreaking study on the efficacy of an at-home medical device for the treatment of stress and mixed urinary incontinence. Read more below to understand how we delivered a successful, fully virtual clinical trial in the midst of the pandemic.