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Digital Support Systems to Improve Child Health and Development in Peru

Study acronym: DigitalECD
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fieldsv6
  2. Minor Primary completion date: Dec 21, 2024 to Apr 30, 2025 Completion date: Dec 31, 2025 to Jun 30, 2026v5 Show 1 more changeShow less
    • Completion date: Dec 31, 2025 to Jun 30, 2026
  3. Minor 2 versions Re-verified since Feb 27, 2023, no change to tracked fieldsv3-v4
  4. Minor Secondary endpoints: details revised at 4 of 4 entries Study description shortened, about 45 words · Study title shortened, about 5 wordsv2 Show 2 more changesShow less
    • Study description shortened, about 45 words
    • Study title shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
About 250 million children under age five are at risk of not reaching their developmental potential due to continued exposure to ill health, malnutrition and lack of appropriate learning environments. A large number of initiatives have been launched in recent years to support early childhood development, with home visiting programs increasingly being recognized as a key strategy for improving child wellbeing. However, the most effective ways to reach families in low income settings remain unclear due to the large expense associated with personal family visits. This project assesses the effectiveness and equity of a newly developed digital platform designed to deliver evidence-based, individualized parenting support through automated services. The Afinidata platform uses state-of-the art machine learning algorithms to allow caregivers to get answers to questions about child health and development, while also identifying and promoting age- and development-appropriate activities for parents to support their children. The goal of this study is to rigorously assess the reach, impact and cost effectiveness of this digital platform in a poor rural population through a randomized controlled trial. The study is designed as mixed-methods evaluation approach with repeated feedback into the Afinidata system. A total of 2400 newborns will be enrolled in a randomized controlled trial in San Marcos, Peru, and followed up for two years. The primary study outcome will be children's healthy development at 24 months of age assessed through the Bayley Scales of Infant and Toddler Development (BSID-III). Secondary outcomes will be systems utilization, program coverage and cost-effectiveness, as well as caregiver satisfaction. If proven effective, this innovative digital platform may increase global access to low-cost parental support -a widely recognized key strategy for improving child well-being.
Trial Details
NCT Number NCT05202106
Lead Sponsor Swiss Tropical & Public Health Institute
Collaborators: Harvard University, ETH Zurich (Switzerland), Universidad Peruana Cayetano Heredia
Conditions Child Development
Enrollment 2,400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov