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  9. Perinatal and Maternal Research
  1. NCTR Research Focus Areas

Perinatal and Maternal Research

Picture of a mother with a sleeping baby

Perinatal and Maternal Research

Perinatal (i.e., the periods of time including pregnancy, childbirth, and infant/child development) and maternal health have been cornerstones of NCTR regulatory science research for over 40 years. 

Many drugs and other medical products provided to pregnant women, neonates, and infants are used off-label due to ethical concerns performing clinical trials in these understudied populations.  In addition, environmental exposure through foods represents another knowledge gap; infants consume more food per kilogram of body weight than any other age group, which could result in higher dietary exposures to chemicals. Often there is little to no available data to assess potential risks with these exposures; thus, safety and risk assessments for foodborne chemicals, biological-, and/or chemical-threat agents rely upon data obtained from animal models and in vitro cellular toxicology studies. 

Congress directed NCTR to lead efforts to create and manage the FDA virtual Perinatal Health Center of Excellence (PHCE). The PHCE was established in 2018 as an FDA-wide collaborative effort to review and fund research related to perinatal populations on an annual basis. 

With the support of collaborating product centers, NCTR coordinates the activities of the PHCE to conduct studies that address important perinatal regulatory-science needs. PHCE-funded research falls into the following categories: new alternative models, traditional toxicology studies, translational and clinical studies, computational modeling, bioanalytical chemistry, exposure science, and bioinformatics targeting. The highest priority during the selection process is given to projects with a potential for wide regulatory impact, including policy changes and realigning industry standards, thereby improving clinical practice and research approaches.


Selected PHCE Publications

"Adaptive Immune Responses to SARS-CoV-2 Persist in the Pharyngeal Lymphoid Tissue of Children." Nature Immunology (2023).
"Bench Testing Performance of Deep Learning-Based CT Image Denoising Methods: Influence of Object Background on Image Sharpness and Noise Texture." SPIE Medical Imaging (2023).
"An FDA Guide on Indications for Use and Device Reporting of Artificial Intelligence-Enabled Devices: Significance for Pediatric Use." J Am Coll Radiol (2023).
"Inorganic Arsenic Alters the Development of Dopaminergic Neurons But Not Serotonergic Neurons and Induces Motor Neuron Development via Sonic Hedgehog Pathway in Zebrafish." Neuroscience Letters (2023).
"Landscape and Regulatory Perspective on Oncology Drugs in Pregnancy." J Clin Pharmacol (2023).
"Neonatal Outcomes and Indirect Consequences Following Maternal SARS-CoV-2 Infection in Pregnancy: A Systematic Review." BMJ Open (2023).
"Pharmacokinetics of Antibodies During Pregnancy: General Pharmacokinetics and Pregnancy Related Physiological Changes (Part 1)." International Immunopharmacology (2023).
"Pharmacokinetics of Antibodies During Pregnancy: Impact of Pregnancy on the Pharmacokinetics of Antibodies (Part 2)." International Immunopharmacology (2023).
"An Antibody from Single Human VH-Rearranging Mouse Neutralizes All SARS-CoV-2 Variants Through BA.5 by Inhibiting Membrane Fusion." Science Immunology (2022).
"Comprehensive Profiling of the Human Viral Exposome in Households Containing an At-Risk Child with Mitochondrial Disease During the 2020–2021 COVID-19 Pandemic." Clinical and Translational Medicine (2022).
"Cross-Reactive Immunity Against the SARS-CoV-2 Omicron Variant is Low in Pediatric Patients with Prior COVID-19 or MIS-C." Nature Communications (2022).
"Developing an In Vitro to In Vivo Extrapolation (IVIVE) Model to Predict Human Milk-to-Plasma Drug Concentration Ratios." Molecular Pharmaceutics (2022).
"Durability of Immunity Is Low Against Severe Acute Respiratory Syndrome Coronavirus 2 Omicron BA.1, BA.2, and BA.3 Variants After Second and Third Vaccinations in Children and Young Adults With Inflammatory Bowel Disease Receiving Biologics." Gastroentorology (2022).
Evaluation of the Robustness of Cerebral Oximetry to Variations in Skin Pigmentation Using a Tissue-Stimulating Phantom." Biomedical Optics Express (2022).
"Exploring the Knowledge Gaps in Infant Drug Exposure From Human Milk: A Clinical Pharmacology Perspective." The Journal of Clinical Pharmacology (2022).
"Exploring Maternal-Fetal Pharmacology Through PBPK Modeling Approaches." Frontiers in Pediatrics (2022).
"Fetal Clinical Pharmacology: A New Frontier of Drug Safety and Therapeutics." The Journal of Clinical Pharmacology (2022).
"Improving Development of Drug Treatments for Pregnant Women and the Fetus." Therapeutic Innovation & Regulatory Science (2022).
"In Vivo Pharmacokinetic Analyses of Placental Transfer of Three Drugs of Different Physicochemical Properties in Pregnant Rats." Reproductive Toxicology (2022).
"Knowledge, Attitude, and Beliefs of Medication Use in Pregnancy in an Urban Tertiary Care Center." The Journal of Clinical Pharmacology (2022).
"Neutralization of Severe Acute Respiratory Syndrome Coronavirus 2 Omicron and Other Variants in Serum From Children With Vaccination-Induced Myocarditis." Clinical Infectious Diseases (2022).
"SARS-CoV-2 mRNA Vaccine Induced Higher Antibody Affinity and IgG Titers Against Variants of Concern in Post-Partum vs Non-Post-Partum Women." eBioMedicine (2022).
"Systemic and Lower Respiratory Tract Immunity to SARS-CoV-2 Omicron and Variants in Pediatric Severe COVID-19 and Mis-C." Vaccines (2022).
"Zika Virus Infection and Antibody Neutralization in FcRn Expressing Placenta and Engineered Cell Lines." Vaccines (2022).
Genetic Toxicity Testing Using Human In Vitro Organotypic Airway Cultures: Assessing DNA Damage With the CometChip and Mutagenesis by Duplex Sequencing.” Environmental and Molecular Mutagenesis (2021).
"Immune Responses and Therapeutic Challenges in Paediatric Patients with New-Onset Acute Myeloid Leukaemia and Concomitant COVID-19." British Journal of Haematology (2021).
"Infant Ear Canal Modeling." Journal of the Acoustical Society of America (2021).
"Mechanistic Modeling of Placental Drug Transfer in Humans: How Do Differences in Maternal/Fetal Fraction of Unbound Drug and Placental Influx/Efflux Transfer Rates Affect Fetal Pharmacokinetics?" Frontiers in Pediatrics (2021).
Methodologic Approaches in Studies Using Real-World Data (RWD) to Measure Pediatric Safety and Effectiveness of Vaccines Administered to Pregnant Women: A Scoping Review.” Vaccine (2021).
"Pharmacoethics and Pregnancy: Overcoming the Therapeutic Orphan Stigma." British Journal of Clinical Pharmacology (2021).
"Regulatory Considerations for the Mother, Fetus and Neonate in Fetal Pharmacology Modeling.” Frontiers in Pediatrics (2021). 
"SARS-CoV-2 Immune Repertoire in MIS-C and Pediatric COVID-19.” Nature Immunology (2021).
"Survey of Acoustic Output in Neonatal Brain Protocols." Journal of Magnetic Resonance Imaging (2021).
"Acoustic Noise Measurements During Neonatal Magnetic Resonance Scans." Journal of the Acoustical Society of America (2020).
Characterizing Biopersistence Potential of the Metabolite 5:3 Fluorotelomer Carboxylic Acid After Repeated Oral Exposure to the 6:2 Fluorotelomer Alcohol.” Toxicology and Applied Pharmacology (2020).
""Methodologic Approaches in Studies Using Real-World Data to Measure Pediatric Safety and Effectiveness of Vaccines Administered to Pregnant Women: A Scoping Review Protocol." JBI Evidence Synthesis (2020).
"Skin Pigmentation Impact on Cerebral Oximetry: Development and Implementation of a Phantom-Based Test Method (Conference Presentation)." SPIE BiOS (2019).


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