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. 2024 Dec:70:101451.
doi: 10.1016/j.dcn.2024.101451. Epub 2024 Sep 18.

Biospecimens in the HEALthy Brain and Child Development (HBCD) Study: Rationale and protocol

Elinor L Sullivan  1 , Ryan Bogdan  2 , Ludmila Bakhireva  3 , Pat Levitt  4 , Joseph Jones  5 , Michael Sheldon  6 , Julie M Croff  7 , Moriah Thomason  8 , Jamie O Lo  9 , Leigh MacIntyre  10 , Susmita Shrivastava  11 , Leigh-Anne Cioffredi  12 , Andrea G Edlow  13 , Brittany R Howell  14 , Barbara H Chaiyachati  15 , Nicole Lashley-Simms  16 , Kelly Molloy  17 , Cris Lam  18 , Anna M Stoermann  18 , Thanh Trinh  18 , Namasivayam Ambalavanan  19 , Jenae M Neiderhiser  20 ; HBCD Biospecimens Workgroup
Affiliations

Biospecimens in the HEALthy Brain and Child Development (HBCD) Study: Rationale and protocol

Elinor L Sullivan et al. Dev Cogn Neurosci. 2024 Dec.

Abstract

The HEALthy Brain and Child Development (HBCD) Study, a multi-site prospective longitudinal cohort study, will examine human brain, cognitive, behavioral, social, and emotional development beginning prenatally and planned through early childhood. The longitudinal collection of biological samples from over 7000 birthing parents and their children within the HBCD study enables research on pre- and postnatal exposures (e.g., substance use, toxicants, nutrition), and biological processes (e.g., genetics, epigenetic signatures, proteins, metabolites) on neurobehavioral developmental outcomes. The following biosamples are collected from the birthing parent: 1) blood (i.e., whole blood, serum, plasma, buffy coat, and dried blood spots) during pregnancy, 2) nail clippings during pregnancy and one month postpartum, 3) urine during pregnancy, and 4) saliva during pregnancy and at in-person postnatal assessments. The following samples are collected from the child at in-person study assessments: 1) saliva, 2) stool, and 3) urine. Additionally, placenta tissue, cord blood, and cord tissue are collected by a subset of HBCD sites. Here, we describe the rationale for the collection of these biospecimens, their current and potential future uses, the collection protocol, and collection success rates during piloting. This information will assist research teams in the planning of future studies utilizing this collection of biological samples.

Keywords: Environmental exposures; HBCD, biospecimens, substance use; Prenatal, fetal programming.

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Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Drs. Elinor L Sullivan, Ryan Bogdan, Ludmila Bakhireva, Pat Levitt, Julie M. Croff, Moriah Thomason(,) Jamie Lo(,) Leigh-Anne Cioffredi, Andrea G. Edlow, Brittany R. Howell, Barbara H Chaiyachati, Namasivayam Ambalavanan(,) and Jenae M. Neiderhiser report financial support provided by National Institutes of Health that includes funding grants. In addition, the Children's Hospital of Philadelphia has received payment for the expert testimony of Dr. Chaiyachati when subpoenaed for cases of suspected child abuse. Andrea G. Edlow serves as a consultant for Mirvie, Inc. outside of this work and receives research funding and consultant funding from Merck Pharmaceuticals outside of this work. Julie M. Croff reports financial support provided by Bill & Melinda Gates Foundation and reports a relationship with Oklahoma State University Center for Health Sciences that includes: funding grants, speaking and lecture fees, and travel reimbursement. Joseph Jones is employed by United States Drug Testing Laboratories, a national commercial reference laboratory, that is in the business of selling some of the services mentioned in this manuscript. This relationship did not influence the design or composition of this manuscript. Leigh MacIntyre discloses the following financial interests that may be considered as potential competing interests: She is the CEO and founder of Lasso Informatics, and has an equity stake and receives a salary from the company. Lasso Informatics is involved in the HBCD Study and provides project management and data services. During the course of this research, Lasso Informatics received a professional services contract from HBCD, providing financial compensation for Lasso Informatics’ contribution to the study. This contract was awarded in 2024 and pertains to the work reported in this manuscript. Leigh MacIntyre declares that these financial interests have been disclosed fully and believe they do not compromise the integrity of the research presented in this manuscript. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

None
Graphical abstract
Fig. 1
Fig. 1
HBCD Study Visit and Assessment Timeline. The HBCD Study is assessing prenatal and early childhood development using a variety of methods including caregiver-report, interviews, biomarkers and measures of child brain development, behavior, and physiology.
Fig. 2
Fig. 2
Pilot HBCD Biospecimens Collection. HBCD pilot collection success rates by biospecimen type. Birthing parent blood (V1; n=133), nails (V2; n=96), Saliva (V1-V3; n=374), and Urine (V1; n=143) and Child saliva (V2-V3; n=231), urine (V2-V3, n=157), and stool (V2-V3; n=106) were acquired.
See this image and copyright information in PMC

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