SPRIM PRO, a CRO specializing in innovative clinical trial solutions, has announced the publication of a peer-reviewed study in Frontiers in Pediatrics, validating the accuracy of at-home infant growth monitoring by caregivers. This decentralized approach addresses challenges in infant formula clinical trials, offering a more accessible and efficient method for data collection.
The study, titled "Assessment of the reliability of at-home caregiver-collected anthropometric measurements," demonstrates that with standardized telehealth-guided training, caregivers can reliably collect their infant's anthropometric measurements at home, comparable to measurements taken by pediatric health care professionals. This is particularly relevant given recent infant formula shortages and increased FDA regulations, which have increased the need for clinical trials to assess the safety and tolerability of new formulations.
Reducing Burden and Enhancing Safety
Traditional infant formula trials often require multiple visits to clinical sites, placing a significant burden on caregivers and potentially exposing healthy newborns to viruses and bacteria. SPRIM PRO's validated methodology mitigates these issues by enabling remote data collection, reducing the need for frequent site visits. This not only eases the burden on caregivers but also minimizes the risk of infection for infants.
"We are thrilled to be able to provide objective data demonstrating a methodology in which caregivers can reliably and accurately collect their infant's anthropometric measurements from their home. Adoption of this approach can improve the accessibility of clinical trials and lead to inclusion of a more diverse study population," said Dr. Jenny Ly, Director of Clinical Science at SPRIM PRO.
Streamlining Infant Formula Development
By decentralizing the data collection process, SPRIM PRO's approach allows infant formula companies to bring their products to market more safely and efficiently. The remote methodology ensures rigorous data collection while minimizing risks to infants and reducing the time and resources required for clinical trials.
"We are very excited about the science, rigor, and innovation that we are implementing to bring certainty to our clients on the performance of their formulas and to astutely guard the safety of infants on par with or better than a clinical site through the use of a remote approach," stated Dr Susan Dallabrida, CEO, SPRIM PRO.
