This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.Hypothesis: 1. A pre-discharge (age 95th percentile for age in hours). By using a cohort study design in a racially diverse and predominantly urban population, we will evaluate whether assessment before 72 hours age using the TSB risk zone will provide a more accurate prediction of subsequent hyperbilirubinemia (72 to 144 hrs) than the use of clinical risk factors and whether combining both strategies will be better than each alone. Our site has implemented the 2004 AAP guideline as an institutional policy prior to initiation of the study. All infants will be provided routine newborn care according to institutional policies for good clinical practice and discharged with outpatient follow-up consistent with the revised AAP guideline. The measurement of TSB in a sample obtained at the time of the metabolic screen will be according to clinical routine. Similarly, follow-up evaluations at age 3 to 5 days and age 7 to 14 days are according to recommendations for routine care. Standardized assessment of clinical risk factors for jaundice and standardized assessment of feeding practices have already been adopted in our nursery as Quality Assurance projects.Study protocol: After informed consent from parents of eligible infants, the following interventions will be performed. 1. TcB measurement at the time of the routine metabolic screen and TSB. 2. TcB measurement at age 3 to 5 days and 7 to 14 days. 3. Parental interview at discharge including a) Self declared maternal and paternal racial backgrounds, b) Skin color/tone assessment (color scale), c) Information for follow-up contact. 4. Parent interview at infant's age 30 3 days using a questionnaire to record interim adverse events and verify and complete data collection Outcome: The primary outcome will be the diagnostic performance of the prediction models and rules. 1. The outcome (dependent) variables for the risk assessment strategies are the development of a). Significant hyperbilirubinemia (95th percentile at 72 hours/age). b). TSB at age 3-5 days that exceeds the AAP practice guideline's recommended threshold for initiation of phototherapy. 2. The predictor (independent) variables are all clinical risk factors (grouped into prenatal, natal and postnatal risk factors) that have been previously correlated in univariate analyses with severe neonatal hyperbilirubinemia. 3. Corollary data: This prospective database will be available for additional analyses to improve our understanding of the natural course of newborn jaundice. Eligibility Criteria: Infants of either gender and any racial/ethnic groups are eligible for the study if they are 35 wks GA, cared for in the well baby nursery, and anticipate having their follow-up visits at age 3-5 days and 7-14 days in facilities accessible to the study sites.Exclusion Criteria: Infants will be excluded from enrollment if they have cardio-respiratory distress, dehydration, symptomatic sepsis, major congenital anomalies, or Apgar score 6 at age 5 min, Rh iso-immunization, received systemic antibiotics prior to discharge, or there has been maternal use of phenobarbital within 30 days before delivery.Location: This is primarily a birthing hospital study of infants with mandatory follow-up (office, hospital or home-based) in 3 to 5 days and 7 to 14 days.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
2M01RR000070-45
Application #
7605235
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2007-02-15
Project End
2007-11-30
Budget Start
2007-02-15
Budget End
2007-11-30
Support Year
45
Fiscal Year
2007
Total Cost
$253,954
Indirect Cost
Name
Stanford University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
009214214
City
Stanford
State
CA
Country
United States
Zip Code
94305
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