COVID-19 Vaccine Effectiveness in Pregnant Women and their Infants
The overall goals are to: Determine COVID-19 vaccine effectiveness in pregnant women for preventing laboratory-confirmed COVID-19 and hospitalization for COVID-19 using real-world clinical data; Determine effectiveness of maternal COVID-19 vaccination during pregnancy for infants 0-12 months for outcomes of laboratory-confirmed…
Treatment Initiation for New Episodes of Depression in Pregnant Women
This study will use rigorous methods and rich health care data from a diverse, multi-site study population to study psychotherapy and antidepressant treatments for new episodes of depression during pregnancy. Analyses will include examination of infant outcomes and breastfeeding.
Early Life Exposure to Endocrine Disrupting Chemicals and Child Growth, Adiposity, and Neurodevelopment – DUPLICATED DO NOT ACTIVATE
This study is evaluating whether in-utero exposures to maternal PFCs and PBDEs, individually and/or in combination, are associated with infant growth, adiposity, and neurodevelopment; metabolic determinants of obesity; and neurodevelopment and infant patterns of DNA methylation. The study also aims…
Predicting the Need for Phototherapy After Discharge
Bilirubin screening before discharge is performed to identify neonates at risk for future hyperbilirubinemia. The American Academy of Pediatrics recommends using a graph of bilirubin levels by age (the Bhutani Nomogram) to guide follow-up and a different graph to determine…
Association of infant diet with subsequent obesity at 2-5 years among children exposed to gestational diabetes: the SWIFT study
This longitudinal analysis evaluated the independent and joint associations of any breastfeeding (BF) or exclusive BF (EBF) and intake of sugar-sweetened beverages (SSBs) and 100% fruit juice from birth to 1 year with subsequent overweight and obesity among young children exposed…
Concomitant administration of a liquid formulation of human rotavirus vaccine (porcine circovirus-free) with routine childhood vaccines in infants in the United States: Results from a phase 3, randomized trial
In response to the detection of porcine circovirus type 1 (PCV-1) in the human rotavirus vaccine (HRV), a PCV-free HRV (no detection of PCV-1 and PCV-2 according to the detection limit of tests used) was developed. Liquid (Liq) PCV-free HRV…
A Phase 3, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a 20-Valent Pneumococcal Conjugate Vaccine in Healthy Infants
This study is part of the Phase 3 pediatric clinical development program to evaluate the 20-Valent Pneumococcal Conjugate Vaccine for use in infants and children. This clinical trial will provide key safety and pivotal comparative immunogenicity data in infants to…
COVID-19 Related Changes in Health Care Delivery and Health Outcomes Among Pregnant Women and Their Newborns
This study will examine the impacts that COVID-19 pandemic related changes in health care delivery had on health outcomes among pregnant women and their newborns in Kaiser Permanente Northern California. The study will also evaluate the clinical course of COVID-19…
Validity of diagnosis and procedure codes for identifying neural tube defects in infants
The use of validated criteria to identify birth defects in electronic healthcare databases can avoid the cost and time-intensive efforts required to conduct chart reviews to confirm outcomes. This study evaluated the validity of various case-finding methodologies to identify neural…
Using a 24-Hour Movement Framework to Improve Pregnancy Outcomes
The goal of this K99/R00 Pathway to Independence Award is to better understand associations of 24-hour movement profiles during pregnancy (consisting of physical activity, sedentary behavior, and sleep) and maternal and infant outcomes. This Award includes training in the analysis…
Cord blood DNA methylome in newborns later diagnosed with autism spectrum disorder reflects early dysregulation of neurodevelopmental and X-linked genes
Autism spectrum disorder (ASD) is a neurodevelopmental disorder with complex heritability and higher prevalence in males. The neonatal epigenome has the potential to reflect past interactions between genetic and environmental factors during early development and influence future health outcomes. We…
Understanding racial-ethnic disparities in preterm birth sub-types and prenatal care utilization
The study will examine racial-ethnic disparities in the risk of preterm birth overall and by preterm birth sub-types. It will also study whether the racial-ethnic disparities in preterm births and preterm birth sub-types are modified by the level of prenatal…
Fetal and Early Postnatal Influences on Child Metabolic Health After Gestational Diabetes
This 5-year RO1 study will determine the independent contribution of fetal exposures and early postnatal lifestyle factors on subsequent development of child adiposity and metabolic health among youth (ages 9 to 13 ) exposed to gestational diabetes in utero. The…
Impact of In Utero Marijuana Exposure on Neurodevelopment, Behavior and Mental Health: A Longitudinal Birth Cohort Study
This study will investigate whether maternal prenatal marijuana use increases the risk of impairments in a child's executive functioning and mental health, after accounting for other factors such as tobacco, alcohol, and other drug use; socioeconomic status, and maternal mental…
MAESTRA: Maternal Antecedents of Encephalopathy in Term Infants
This study tests the hypothesis that established NICHD-approved electronic fetal monitoring (EFM) features used as standard care in the U.S. and other developed countries can exhibit improved sensitivity and specificity for predicting HIE when they are combined with novel EFM features…
Neurodevelopmental outcomes in infants receiving opioid-replacement
Infants with Neonatal Opioid Withdrawal Syndrome (NOWS) are often treated with prolonged opioid-replacement pharmacotherapy. Whether opioid exposure in-utero or significant opioid exposure used to treat withdrawal symptoms impacts neurodevelopmental outcomes is unknown. Our aim is to evaluate neurodevelopmental outcomes at…
Neonatal Thyroid Stimulating Hormone and Subsequent Diagnosis of Autism Spectrum Disorders and Intellectual Disability
Hypothyroid conditions in early life, if left untreated, are associated with adverse neurodevelopmental outcomes, including intellectual disability (ID). However, evidence addressing the role of neonatal thyroid hormone insufficiencies in the altered neurobiology underlying autism spectrum disorders (ASD), particularly among its…
Exercise During the First Trimester and Infant Size at Birth: Targeted Maximum Likelihood Estimation of the Causal Risk Difference
This cohort study sought to estimate the differences in risk of delivering infants who were small or large for gestational age (SGA or LGA, respectively) according to exercise during the first trimester of pregnancy (vs. no exercise) among 2,286 women…
Trivalent inactivated influenza vaccine (IIV3) during pregnancy and six-month infant development
Despite recommendations by professional organizations that all pregnant women receive inactivated influenza vaccine, safety concerns remain a barrier. Our objective was to assess the effect of trivalent influenza vaccines (IIV3) during pregnancy on parent report 6-month infant development. We conducted…
Management of Cannabis Use in Breastfeeding Women: The Untapped Potential of Certified Lactation Consultants
Recent increases in maternal cannabis use, in combination with rapidly changing cannabis policies in the United States, pose a unique threat to maternal and child health. To date, 33 states and the District of Columbia (D.C.) have legalized medicinal cannabis,…
Neonatal jaundice in association with autism spectrum disorder and developmental disorder
To examine the association between neonatal jaundice and autism spectrum disorder (ASD) and non-ASD developmental disorder (DD). We analyzed data from the Study to Explore Early Development, a US multisite, case-control study conducted from 2007 to 2011. Developmental assessment classified…
Background rates of maternal, fetal, neonatal, and infant outcomes and events of interest to inform maternal immunization clinical trials
GlaxoSmithKline Vaccines is currently preparing for clinical trials that evaluate the safety/reactogenicity and immunogenicity of a respiratory syncytial virus maternal vaccine candidate in pregnant women. Robust epidemiological data is needed to support the interpretation of maternal and neonatal outcomes in…
Exogenous surfactant utilization for respiratory failure in late and moderately preterm infants: impact on short- and long-term outcomes
The goal is to define and refine the current epidemiology, clinical characteristics, and treatment practices in respiratory failure in late and moderately preterm Infants. Specific aims include determining the incidence and epidemiology of respiratory failure in the neonates born at…
Prenatal Depression and Antidepressant Exposure: Effects on Child Speech and Language Disorders
The aims of this study are to 1) Assess the relationship between untreated prenatal depression and the risk of speech and language disorders of offspring; 2) Compare the effectiveness of treatment of prenatal depression on speech and language disorders of…
Fetal Programming of Growth and Obesity: A Metabolomics Approach
This proposal uses a novel holistic framework that leverages both targeted and untargeted metabolomics approach, electronic health records data, and bioinformatics analytics to investigate the mechanisms by which the in-utero environment may infer risk of fetal growth extremes and altered…
An Exploratory Examination of Neonatal Cytokines and Chemokines as Predictors of Autism Risk: The Early Markers for Autism Study
The identification of an early biomarker for autism spectrum disorder (ASD) would improve the determination of risk, leading to earlier diagnosis and, potentially, earlier intervention and improved outcomes. Data were generated from the Early Markers for Autism study, a population-based…
Maternal Marijuana Use During Pregnancy, Marijuana Legalization, and Adverse Obstetrical and Neonatal Outcomes: A 12-year Cohort Study
The goal of this application is to examine the association between maternal marijuana use during pregnancy and adverse obstetrical and neonatal outcomes. We aim to: 1) Examine trends in prenatal marijuana use following the legalization of marijuana for recreational purposes…
Newborn vitamin D levels in relation to autism spectrum disorders and intellectual disability: A case-control study in california
Vitamin D deficiency has been increasing concurrently with prevalence of autism spectrum disorders (ASD), and emerging evidence suggests vitamin D is involved in brain development. Most prior studies of ASD examined vitamin D levels in children already diagnosed, but a…
Iodinated Contrast Agents and Risk of Hypothyroidism in Young Children in the United States
Although it is generally acknowledged that exposure to iodine contrast agents can interfere with thyroid function, little is known about the incidence of iodine-induced hypothyroidism in young children (younger than the age of 4 years). This was a retrospective cohort…
Association of Infant Temperament With Subsequent Obesity in Young Children of Mothers With Gestational Diabetes Mellitus
Infant temperament is associated with excess weight gain or childhood obesity risk in samples of healthy individuals, although the evidence has been inconsistent. To our knowledge, no prior research has examined this topic among children exposed to gestational diabetes mellitus…
Meta-analysis of epigenome-wide association studies in neonates reveals widespread differential DNA methylation associated with birthweight
Birthweight is associated with health outcomes across the life course, DNA methylation may be an underlying mechanism. In this meta-analysis of epigenome-wide association studies of 8,825 neonates from 24 birth cohorts in the Pregnancy And Childhood Epigenetics Consortium, we find…
Birth in High Infant Mortality States and Dementia Risk in a Cohort of Elderly African American and White Health Care Members
Birth in areas with high infant mortality rates (IMRs) has been linked to worse long-term health outcomes, yet it is completely unknown if it impacts dementia risk. In total 6268 health care members were followed for dementia diagnosis from 1996…
Immunogenicity and safety of the Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine co-administered with human rotavirus, hepatitis A and 13-valent pneumococcal conjugate vaccines: results from a phase III, randomized, multicenter study in infants
This phase III, open-label, randomized study (NCT01978093) evaluated the immunogenicity and safety of co-administered Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine (Hib-MenCY-TT) with human rotavirus vaccine (HRV), hepatitis A vaccine (HAV) and 13-valent pneumococcal conjugate…
Weight estimation among multi-racial/ethnic infants and children aged 0-5·9 years in the USA: simple tools for a critical measure
In resource-constrained facilities or during resuscitation, immediate paediatric weight estimation remains a fundamental challenge. We aimed to develop and validate weight estimation models based on ulna length and forearm width and circumference measured by simple and portable tools; and to…
Immunogenicity and safety following primary and booster vaccination with a hexavalent diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b vaccine: a randomized trial in the United States
Combined hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliomyelitis and Haemophilus influenzae type b vaccine (DTaP-HBV-IPV/Hib) can further reduce the number of injections in pediatric immunization schedules of countries currently using pentavalent DTaP combination vaccines. This open-label, randomized, multicenter study (NCT02096263) conducted in…
Incremental Cost of Prematurity by Week of Gestational Age
Objective This study was aimed to compare health care costs and utilization at birth through 1 year, between preterm and term infants, by week of gestation. Methods A cross-sectional study of infants born at ≥ 23 weeks of gestational age (GA) at Kaiser…
Antenatal and Intrapartum Risk Factors for Hypoxic-Ischemic Encephalopathy in a US Birth Cohort
To identify risk factors for hypoxic-ischemic encephalopathy (HIE) within a recent US birth cohort. In a retrospective cohort study of 44 572 singleton infants ?36 weeks of gestation born at Kaiser Permanente Northern California in 2008-2015, we identified all infants…
Maternal exposure to bisphenol A and anogenital distance throughout infancy: A longitudinal study from Shanghai, China
Bisphenol A (BPA) is one of the most common endocrine-disrupting compounds (EDCs) with a ubiquitous presence. Both animal and human studies have reported the association between maternal exposure to BPA and anogenital distance (AGD) in offspring. However, the results are…
Prevalence of infant bronchiolitis-coded healthcare encounters attributable to RSV
We sought to determine the proportion of bronchiolitis episodes attributable to respiratory syncytial virus (RSV) among ICD-9 coded infant bronchiolitis episodes which were tested for RSV. Bronchiolitis healthcare encounters were extracted from Kaiser Permanente Northern California databases for years 2006…
Uptake and safety of Hepatitis B vaccination during pregnancy: A Vaccine Safety Datalink study
Hepatitis B virus (HBV) infection acquired during pregnancy can pose a risk to the infant at birth that can lead to significant and lifelong morbidity. Hepatitis B vaccine (HepB) is recommended for anyone at increased risk for contracting HBV infection,…
Childhood Seizures After Phototherapy
: media-1vid110.1542/5804915133001PEDS-VA_2018-0648Video Abstract BACKGROUND AND OBJECTIVES: In a recent Danish study, researchers found an increased risk of childhood epilepsy after phototherapy but only in boys. We investigated this association in a Kaiser Permanente Northern California cohort. From 499?642 infants born…
Cross-genetic determination of maternal and neonatal immune mediators during pregnancy
The immune system plays a fundamental role in development during pregnancy and early life. Alterations in circulating maternal and neonatal immune mediators have been associated with pregnancy complications as well as susceptibility to autoimmune and neurodevelopmental conditions in later life.…
AHR gene-dioxin interactions and birthweight in the Seveso Second Generation Health Study.
Background: 2, 3, 7, 8-tetrachlorodibenzo-p-dioxin (TCDD) is proposed to interfere with fetal growth via altered activity of the aryl hydrocarbon receptor (protein: AHR; gene: AHR) pathway which regulates diverse biological and developmental processes including xenobiotic metabolism. Genetic variation in AHR…
Television viewing, bedroom television, and sleep duration from infancy to mid-childhood.
BACKGROUND: Television and insufficient sleep are associated with poor mental and physical health. This study assessed associations of TV viewing and bedroom TV with sleep duration from infancy to midchildhood.METHOD: We studied 1864 children in Project Viva. Parents reported children's…
Influence of site differences between urban and rural American and Central European opioid-dependent pregnant women and neonatal outcome characteristics.
BACKGROUND: Multi-center trials enable the recruitment of larger study samples, although results might be influenced by site-specific factors.METHODS: Site differences of a multi-center prospective double-blind, double-dummy randomized controlled trial (7 centers: Central Europe (Vienna)/USA (3 urban/3 rural centers)) comparing safety…
Opioid dependent and pregnant: what are the best options for mothers and neonates?
Pregnancy in opioid-dependent women is a major public health issue. Women who are afflicted by opioid addiction are a highly vulnerable group of patients frequently becoming pregnant unplanned and at risk of adverse pregnancy outcomes and peri-natal complications. Opioid agonist…
Impact of treatment approach on maternal and neonatal outcome in pregnant opioid-maintained women.
OBJECTIVE: The objective of this study is to compare maternal and neonatal outcome of opioid-dependent women maintained on buprenorphine or methadone throughout pregnancy in a randomized double-blind double-dummy clinical trial (CT) with a comparison group undergoing a structured standard protocol…
Association between prenatal tobacco exposure and outcome of neonates born to opioid-maintained mothers. Implications for treatment.
BACKGROUND: Prenatal nicotine exposure is associated with increased neonatal mortality, low birth weight, and smaller head circumference. Opioid-dependent pregnant women show a particularly high prevalence of tobacco smoking and are at greater risk for additional adverse events. However, little is…
