Children are not small adults. Their trials should not be designed like they are.
Over 50% of American parents give their children supplements regularly. Yet children are dramatically underrepresented in nutraceutical research. NRI specializes in the design and execution of ethical, rigorous clinical trials in pediatric populations.
Adult-focused research applied to children is a methodology error, not a safety measure
Many formulators create pediatric products based on adult-focused research and reduce the dosing. This approach is often presented as conservative and protective. It is neither.
Children have fundamentally different physiology from adults. Immature digestive, respiratory, and immune systems. Different rates of absorption, distribution, metabolism, and elimination. Different dietary and lifestyle patterns. All of these factors define how a product works in a child's body, and none of them are captured by adult trials.
The result is a natural products industry that is making pediatric claims without pediatric evidence. That is not a gap that dosage reduction can close.
If your product boosts immune function as kids head back to school, it needs to be studied in school-age children. If it targets common childhood stressors, it needs to be tested in children experiencing those stressors. There is no shortcut around this.
The FDA and FTC guidance is clear: people in your trials must match the people using your product. Adult trials cannot substantiate claims made about child health.
If a product is safe enough to be on the shelves, it is safe enough for clinical research
Keeping children out of clinical trials is often framed as protecting them from uncertainty. This framing makes sense for untested pharmaceuticals. It does not make sense for natural products that children are already consuming every day.
The overwhelming majority of children using nutraceuticals, essential oils, and herbal products are already in an uncontrolled real-world experiment. A well-designed clinical trial with ethical oversight, validated instruments, non-invasive endpoints, and rigorous monitoring is categorically safer than that.
Refusing to study products in the populations that use them does not protect children. It leaves them without evidence-based guidance and the industry without the data it needs to formulate responsibly.
Children are a unique population with distinct developmental and physiological differences from adults. Clinical trials in children are essential to develop age-specific, empirically-verified therapies and interventions to determine and improve the best medical treatment available.
The first and only validated psychometric suite for pediatric natural product research
Navigating pediatric trials requires a white-glove approach. Invasive strategies are rarely justified for preventive-focused natural products. Yet children are consistently ignored in the development of standardized health outcome measurements, leaving researchers with few validated options.
NRI has developed and validated a proprietary suite of pediatric psychometric instruments specifically for natural product research in healthy pediatric populations. These are the first tools of their kind in the field.
Non-invasive endpoints
All NRI pediatric instruments use validated self-report and parent-report measures. No blood draws, no clinical procedures, no invasive data collection required for efficacy measurement.
Holistic measurement
NRI's pediatric suite captures immune support, respiratory function, stress, sleep, and cognitive outcomes using a holistic model of health that recognizes the unique functions of immature pediatric systems.
Regulatory alignment
Every instrument is designed to produce data that meets regulatory standards for natural supplement claims. The evidence you generate will hold up to FTC and FDA scrutiny because it was built with that standard in mind.
A published record in pediatric natural product research
Dr. Cavanaugh has published the first meta-analyses in pediatric aromatherapy for procedural distress. She designed the epidemiological series on lavender and tea tree safety in prepubertal children. She has conducted RCTs on essential oil use in pediatric populations and published on home use patterns and safety across age groups.
This is not a team learning how to work with children. It is a team that built the methodological infrastructure for this field from the beginning.
Meet Dr. Cavanaugh →Conditions we study in children
Immune support and respiratory health · Stress and anxiety · Sleep · Skin conditions · Pain and procedural distress · Cognitive function and focus · Gut health · General wellness and prevention
NRI's pediatric suite represents the first and only non-invasive measurement tools designed specifically to capture the efficacy of natural products in healthy pediatric populations.
Ready to design a pediatric trial?
Every NRI engagement starts with a direct conversation about your compound, your claims, and your population.