This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The Clinical Phenotype/Patient Sample Core will streamline access to clinical data and patient samples for the Pacific Research Center for Early Human Development (PRCEHD) investigators and other clinical investigators at JABSOM. The clinical phenotyping component of the Core consists of a new perinatal/neonatal database, a new placental bank, and the option for a standardized neonatal examination and improved neonatal follow-up capability. The patient sample component of this Core will provide ascertainment and recruitment of potential research subjects, ongoing collection of relevant specimens, efficient protocols to provide specimens and accompanying clinical data (as necessary) to investigators, and storage of materials in a sample repository. Finally, the core laboratory will offer basic and advanced pathology techniques to current and future projects.
The specific aims of this Core are: 1) to build a new research database focused on perinatal and neonatal conditions, 2) to bank placental data and samples for all high-risk pregnancies for which standard pathological examinations were not requested by the attending physician or midwife, 3) to provide consistent and detailed physical examinations and anthropomorphic measurements on selected neonates, 4) to collect, access, archive, and distribute to the CCRE investigators high-quality tissue and blood specimens and relevant clinical data from obstetric and neonatal patients. This request for CRC personnel and facilities support is limited to the implementation of specific aim 4) (as listed above). The Core does not directly involve human subjects in experiments. The objective of this Core is to recruit all women delivering at Kapi'olani Medical Center for Women and Children (KMCWC). The Clinical Research Center's (CRC's) involvement in the study includes the collection of maternal blood samples or cheek swabs (similar to a Q-tip), cord blood samples, and placentas;and the transporting of these tissues to the JABSOM Clinical Phenotype/ Patient Sample Core Lab. All tissue samples and personal information will be securely maintained at the JABSOM Clinical Phenotype/Patient Sample Core laboratory for research use. All potential subjects will be pregnant, or recently delivered, inpatients at Kapi'olani Medical Center for Women and Children. The subjects will be 18-50 years of age, and will be able to read, speak and understand English. We will not include incarcerated women in this study. All subjects will be enrolled and consented prior to the collection of their personal health information and biomedical tissues. All subjects will be mentally competent to understand the consent process and the study procedures. There are no ethnic exclusions in this study. A record of ethnic background will be part of the patient database so that this factor can be analyzed.
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