This research involves collecting biospecimens from 7,000 birthing parents and their children to investigate how prenatal and postnatal experiences influence children’s neural, cognitive, behavioral, social, emotional, and health outcomes.

The Impact of Early Experiences and Exposures on Infant Health Outcomes

The development of the human nervous system is a complex process, beginning a few weeks after conception and continuing throughout gestation and long after birth. This development is driven by a complex interplay of genetic and environmental factors, with the late prenatal stage and early infancy marking a period of exceptionally rapid and significant change. Although it is well understood that these factors impact childhood development across biological and social domains, the precise causal relationships between early exposures and subsequent behavior remain unclear. Therefore, gathering diverse data from birthing parents and their children during both prenatal and postnatal stages is essential for uncovering the biological mechanisms that link early-life exposures to developmental outcomes.

In this manuscript, the research team presents the rationale behind the study, detailing the selection of specific biospecimen collections (e.g., blood, saliva, nails) and other tests conducted at various developmental stages (i.e., prenatal, 0–1 month, 3–9 months, 9–15 months). The study design aims to balance the depth of phenotypic information collected with considerations of participant burden and other relevant factors.

EL Sullivan, R Bogdan, L Bakhireva, et al., Biospecimens in the HEALthy Brain and Child Development (HBCD) Study: Rationale and protocol, Developmental Cognitive Neuroscience, Volume 70, 2024, 101451, ISSN 1878-9293. https://doi.org/10.1016/j.dcn.2024.101451.

Cohort Selection

The HBCD study was designed to consider population diversity and specific substance exposures. Accurate representation of the broader population is essential to minimize bias in large cohort studies. At the same time, a key goal of the study is to examine infant exposure to substances such as opioids, marijuana, alcohol, tobacco, and others. To achieve both aims, the researchers organized the cohort into three categories.

1. 50% – Racially, ethnically, and socioeconomically diverse cohort representative of the U.S. population
2. 25% – Pregnant persons with use of targeted substances
3. 25% – Individuals demographically and behaviorally similar to group two but without substance use during pregnancy

All participating birthing parents are between 18 and 50 years of age and will have given birth 12 months before the start of the study.

Parameter Selection

Data is collected from biospecimen analysis (i.e., genomics/epigenomics), questionnaires, interviews, biosensors, behavioral, electroencephalogram (EEG), and magnetic resonance imaging (MRI). This enables researchers to link prenatal and postnatal experiences, including:

• Physical health
• Behavior
• Neurocognition/language capabilities
• Neurodevelopment
• Activity and sleep

Biospecimen collection is a central component of the HBCD study, providing researchers with objective insights into various biological mechanisms and exposure to specific target substances. The types of biospecimens to be collected and the rationale for their collection include:

• Blood: To assess biomarkers and environmental exposures in the birthing parent
• Urine: To assess proteins and environmental exposures
• Nails: To index substance exposure
• Saliva: For genetic material and to track epigenetic changes over time
• Stool: To facilitate microbiome studies in child participants

Sampled, a CAP-accredited and CLIA-licensed analytical laboratory and biorepository, performs the ongoing specimen collection logistics, sample storage, and analytical processing.

Implications for Research

The HBCD study aims to generate a comprehensive collection of high-quality biospecimens and associated data for future use by diverse research teams. In addition to providing these resources, the researchers offer guidance on effectively applying the data to various fields, including genomics, nutrition, toxicology, inflammation, microbiome, and metabolomics. The depth and robustness of this data will support a wide range of research areas and help address longstanding questions about how early experiences and exposures influence neurocognitive and behavioral development.

“The design of the HBCD study, pairing the longitudinal collection of extensive phenotypic data with varied biospecimens, will enable researchers to interrogate the complex relationships in child development between genetics, environment and maternal drug exposure using state-of-the-art multiomics approaches including bulk and single cell next generation sequencing, epigenomics, metagenomics, and metabolomics.“

Michael Sheldon, PhD

Dr. Sheldon has a career spanning more than 30 years in genetic research and biobanking. In 2021, he founded the Scientific Affairs department at Sampled with the mission to provide expert technical resources to clients, discovery and adoption of new technologies, and the coordination of outreach initiatives. Prior to that he served as Senior Director of Sample Processing Services at RUCDR Infinite Biologics (now Sampled), with oversight of all sample processing services relating to blood fractionation, cell and stem cell culture, and nucleic acid extraction.

Dr. Sheldon received his B.A. from Cornell University in 1983 and a Ph.D. from SUNY at Stony Brook in 1993. He is an Adjunct Professor of Genetics at Rutgers University and is a published researcher in Genetics, Neurodevelopment, and Stem Cell biology.

In this evolving paradigm, the need for sophisticated analytical platforms and robust biorepositories has become paramount. Sampled’s Global Integrated Analytical Biorepository (GIAB) emerges as a cornerstone for researchers, offering unparalleled capabilities in managing and analyzing complex biological samples. In this article we look at 5 reasons how the GIAB is poised to revolutionize clinical trials.

1. Access to Expertise

At the heart of Sampled’s GIAB lies our team of technical experts. With extensive experience in biobanking, sample processing, kitting and multiomics analysis, our experts ensure the highest standards of sample management, storage, and analysis by following up to date SOPs and best practices.

One example of how our experts can help is when it comes to completing sequencing investigations, this type of research can be daunting if you are new to sequencing or have never performed whole exome sequencing before. Even if you have the right sequencing platform in-house, you may not have the right team of experts to sequence your samples, and just one mistake in sequencing can result in costly errors that could lose your team time and resources.

This is especially important to consider if the sample you’re looking to sequence is finite or irreplaceable such as patient samples. This is another reason why researchers are outsourcing their work to Sampled, as our highly trained experts are able to help you with experimental design and reduce turn-around-times.

2. Compliance with Clinical Trial Regulatory Bodies

Navigating the regulatory landscape is a daunting challenge for pharmaceutical companies conducting clinical trials. Our GIAB alleviates this burden by adhering rigorously to regulatory guidelines and industry best practices. For example, regulatory bodies such as the FDA require access to a wide range of data from cryostorage temperature logs for samples that were transported between sites to genomic data. If your data is unreliable, inaccurate or does not comply with their rules and regulatory standards it could spell disaster and delay the product’s release.

Outsourcing cryogenic storage to our GIAB, ensures samples are stored under regulatory-compliant conditions, facilitating smooth regulatory review processes. This is because our team of experts are trained to follow the latest SOPs that conform to processes laid out by regulatory bodies such as the FDA. Not only will your sample’s integrity be preserved for years to come, but they will also meet the requirements laid out by major regulatory bodies should they be recalled from storage for review.

3. Cost-effective and Resource Optimization

Running clinical trials, especially those involving biologics, demands significant financial resources and infrastructure. Sampled’s GIAB offers a cost-effective solution by streamlining sample management processes and optimizing resource utilization. By outsourcing sample handling and analysis to Sampled, researchers can minimize overhead costs associated with in-house biorepositories (which can be prohibitively expensive in labs based in major cities) and focus their resources on core research activities, accelerating the pace of drug development.

Likewise, by outsourcing research to our trained experts, researchers can save on overheads associated with hiring and training new staff which saves on capital expenditure and time. Similarly, since Sampled is a service partner with many major platform manufacturers such as 10X Genomics, Illumina, Olink, PacBio and Twist Biosciences, researchers no longer need to purchase costly platforms. Instead, they can work with Sampled’s experts to ensure their samples are analyzed in the manner they wish without having to spend time optimizing multiple platforms and maintaining them.

4. Centralized Sample Management

One of the most significant advantages of Sampled’s GIAB is its centralized sample management system. By consolidating samples from multiple clinical sites into a single biorepository, our GIAB facilitates seamless collaboration and data sharing among researchers. This centralized approach not only enhances efficiency but also ensures sample consistency and uniformity, mitigating variability and improving the reliability of research outcomes.

By taking a consistent and uniform approach to sample storage, management analysis and kitting, researchers can significantly reduce the risk of generating results that are not reproducible. In turn giving researchers the confidence that the results they are seeing are not only accurate but reproducible.

5. Enhanced Data Security and Quality Control

Data security and quality control are paramount in clinical research, especially when dealing with sensitive patient information and biological samples. Our GIAB employs stringent protocols and SOPs to safeguard data integrity and confidentiality. From robust data encryption to real-time monitoring of sample conditions, Sampled prioritizes data security and implements rigorous quality control measures at every stage of the sample lifecycle.

In conclusion, Sampled’s GIAB stands at the forefront of innovation in clinical trial management, offering researchers a comprehensive solution for handling, storing and analyzing complex biological samples. With our expertise, regulatory compliance know how, cost-effectiveness and centralized sample management, we are poised to revolutionize the way clinical trials are conducted in the era of biologics dominance. Ultimately, helping researchers to unlock new insights, accelerate drug discovery, and improve patient outcomes.

Speak to one of our experts today to learn more about how we can help your clinical research