studying infants & children is easier with microsampling

Pediatric research studies are essential because they improve health and healthcare for infants and children. They allow scientists conducting pediatric studies to detect diseases early and to design better methods for evidence-based drugs and appropriate dosing.

Conducting pediatric studies is challenging. A recent survey shows that 40% of the trials launched between 2008-2011 were not completed, and the results were never published. One thing that contributed to this involved the significant challenge of sample collection.

For clinical studies to be valid, researchers must collect biological fluid samples from study participants. Although researchers often choose to use gentler, minimally invasive sampling methods, the frequent sampling needed for a study can cause babies and children physical, emotional or psychological distress. If the sampling is performed via the conventional needle-poke in the arm — especially if repeated daily or weekly — that can amount to a lot of painful pokes, resulting in "needle fatigue."

A quick heel-stick or finger-stick with a tiny lancet, meanwhile, may not be pleasant for infants and small children, but is much quicker and less traumatic than being poked with a large needle to draw large blood volumes during a more extended sample collection event.

How Microsampling Helps Children

To overcome sampling challenges in pediatric studies, more researchers are now using methods that don’t traumatize children or jeopardize their health. Microsampling provides the option for remote sample collection that doesn't involve a phlebotomist or nurse. Study participants and their parents or caregivers can perform their sample collection at home. This can relieve a lot of stress, and also means that families don’t need to physically visit the trial site for sample collection and follow-up as often.

Mitra^® devices and Mitra Collection Kits provide a DIY (do-it-yourself) approach to sample collection. The procedure is simplified for parents and caregivers. The kits include illustrated instructions that visually demonstrate how to collect samples at home or elsewhere. Most people can follow the pictures and simple guidelines to complete each step in the specimen collection process. After sample collection, they use the provided packaging to mail their samples to the lab for the study.

How Microsampling Helps Clinical Studies

Microsampling also provides a much-needed benefit for pharmacokinetic clinical trials in vulnerable populations. Study surveys show that 96% of parents and guardians and 100% of attending nurses agree that microsampling is a highly acceptable and recommendable blood collection method for pediatric patients. 

Approximately 61% of caregivers reported that microsampling procedures are relatively painless for their youngsters, compared to 26% who said their children indicated some pain. Seventy-one percent of bedside nurses “slightly agreed” that children indicated some pain with finger-stick microsampling.

Despite the obvious advantages of finger-stick microsampling in young study participants, this approach is not yet commonly used in pediatric clinical studies. Is this due to a lack of awareness of its proven success and efficacy for clinical research, or a reluctance to shift to new methods of specimen collection?

Perspectives in sampling for pediatric studies may shift once there are more efforts to gather qualitative information about the sampling experience from parents, primary caregivers, and nurses involved in pediatric studies. Their views may help researchers ascertain if the finger-stick microsampling approach improves study subject retention and compliance in pediatric studies. The published results may encourage the adoption of microsampling on a much broader scale.