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OBJECTIVE: To evaluate the incidence, indications and outcomes with neonatal extracorporeal membrane oxygenation (ECMO) and its association with therapeutic hypothermia (TH) among infants undergoing invasive mechanical ventilation (IMV) in California during 2013-2020. STUDY DESIGN: We analyzed data on neonates ≥34 weeks gestation with ≥4 h of IMV over an 8-year period (2013-2020) from the California Perinatal Quality Care Collaborative (CPQCC) database. RESULTS: Between 2013 and 2020, the ranges for utilization of iNO (13.9 to 17.2%), ECMO (2.1 to 2.5%), TH (10.2 to 15.7%) and TH + ECMO (0.4 to 0.8%) were observed. The most common association with neonatal ECMO was TH (148 cases, OR 3.2, 95% CI 2.6-4.3, p < 0.01). The combination of meconium aspiration syndrome (MAS) and hypoxic ischemic encephalopathy (HIE) increased risk of iNO and ECMO use (OR 11.3, 1.5-86.9), p = 0.02). CONCLUSION: Ventilated infants ≥34 weeks gestational age undergoing TH are at risk for iNO/ECMO use and need close monitoring.
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BACKGROUND: It is known that cesarean birth affects maternal outcomes in subsequent pregnancies, but specific effect estimates are lacking. We sought to quantify the effect of cesarean birth reduction among nulliparous, term, singleton, vertex (NTSV) births (i.e., preventable cesarean births) on severe maternal morbidity (SMM) in the second birth. METHODS: We examined birth certificates linked with maternal hospitalization data (2007-19) from California for NTSV births with a second birth (N = 779,382). The exposure was cesarean delivery in first birth and the outcome was SMM in the second birth. We used adjusted Poisson regression models to calculate risk ratios and population attributable fraction for SMM in the second birth and conducted a counterfactual impact analysis to estimate how lowering NTSV cesarean births could reduce SMM in second birth. RESULTS: The adjusted risk ratio for SMM in the second birth given a prior cesarean birth was 1.7 (95% CI 1.5-1.9); 15.5% (95% CI 15.3%-15.7%) of this SMM may be attributable to prior cesarean birth. In a counterfactual analysis where 12% of the California population least likely to get a cesarean birth instead delivered vaginally, we observed 174 fewer SMM events in a population of individuals with a low-risk first birth and a subsequent birth. CONCLUSIONS: In our counterfactual analysis, lowering primary cesarean birth among a NTSV population was associated with fewer downstream SMM events in subsequent births and overall. Additionally, our findings reflect the importance of considering the cumulative accrual of risks across the reproductive life-course.
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OBJECTIVE: To determine associations between sociodemographic and medical factors and odds of readmission after discharge from the neonatal intensive care unit for infants with very low birth weight (<1500g). STUDY DESIGN: Cohort study using linked data from the California Perinatal Quality Care Collaborative, California Vital Statistics, and the Child Opportunity Index (COI) 2.0. Infants with very low birth weight born from 2009 through 2018 in California were considered. Odds ratios of readmission within 30 days of discharge adjusting for infant medical factors, maternal sociodemographic factors, and birth hospital were calculated via multivariable logistic regression and fixed-effect logistic regression models. RESULTS: A total of 42â411 infants met inclusion criteria. Also, 8.5% of all infants were readmitted within 30 days of discharge. In addition to traditional medical risk factors, two sociodemographic factors were significantly associated with increased odds of readmission in adjusted models: payor other than private insurance for delivery [aOR = 1.25 (95% CI 1.14-1.36)] and maternal education of less than high school degree [aOR = 1.19 (95% CI 1.06-1.33)]. Neighborhood Child Opportunity Index was not associated with odds of readmission. CONCLUSIONS: Sociodemographic factors, including lack of private insurance and lower maternal educational attainment, are significantly and independently associated with increased odds of readmission after neonatal intensive care unit discharge, in addition to traditional medical risk factors. Socioeconomic deprivation and health literacy may contribute to risk of readmission. Targeted discharge interventions focused on addressing social drivers of health warrant exploration.
Subject(s)
Infant, Very Low Birth Weight , Intensive Care Units, Neonatal , Patient Discharge , Patient Readmission , Humans , Patient Readmission/statistics & numerical data , Intensive Care Units, Neonatal/statistics & numerical data , Female , Infant, Newborn , Patient Discharge/statistics & numerical data , Male , California , Risk Factors , Social Determinants of Health , Cohort Studies , Socioeconomic Factors , Adult , Sociodemographic FactorsABSTRACT
OBJECTIVE: Severe maternal morbidity (SMM) is increasing and characterized by substantial racial and ethnic disparities. Analyzing trends and disparities across time by etiologic or organ system groups instead of an aggregated index may inform specific, actionable pathways to equitable care. We explored trends and racial and ethnic disparities in seven SMM categories at childbirth hospitalization. STUDY DESIGN: We analyzed California birth cohort data on all live and stillbirths ≥ 20 weeks' gestation from 1997 to 2017 (n = 10,580,096) using the Centers for Disease Control and Prevention's SMM index. Cases were categorized into seven nonmutually exclusive indicator categories (cardiac, renal, respiratory, hemorrhage, sepsis, other obstetric, and other medical SMM). We compared prevalence and trends in SMM indicator categories overall and by racial and ethnic group using logistic and linear regression. RESULTS: SMM occurred in 1.16% of births and nontransfusion SMM in 0.54%. Hemorrhage SMM occurred most frequently (27 per 10,000 births), followed by other obstetric (11), respiratory (7), and sepsis, cardiac, and renal SMM (5). Hemorrhage, renal, respiratory, and sepsis SMM increased over time for all racial and ethnic groups. The largest disparities were for Black individuals, including over 3-fold increased odds of other medical SMM. Renal and sepsis morbidity had the largest relative increases over time (717 and 544%). Sepsis and hemorrhage SMM had the largest absolute changes over time (17 per 10,000 increase). Disparities increased over time for respiratory SMM among Black, U.S.-born Hispanic, and non-U.S.-born Hispanic individuals and for sepsis SMM among Asian or Pacific Islander individuals. Disparities decreased over time for sepsis SMM among Black individuals yet remained substantial. CONCLUSION: Our research further supports the critical need to address SMM and disparities as a significant public health priority in the United States and suggests that examining SMM subgroups may reveal helpful nuance for understanding trends, disparities, and potential needs for intervention. KEY POINTS: · By SMM subgroup, trends and racial and ethnic disparities varied yet Black individuals consistently had highest rates.. · Hemorrhage, renal, respiratory, and sepsis SMM significantly increased over time.. · Disparities increased for respiratory SMM among Black, U.S.-born Hispanic and non-U.S.-born Hispanic individuals and for sepsis SMM among Asian or Pacific Islander individuals..
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PURPOSE: Recent studies have demonstrated an increased risk of severe maternal morbidity (SMM) for people living in rural versus urban counties. Studies have not considered rurality at the more nuanced subcounty census-tract level. This study assessed the relationship between census-tract-level rurality and SMM for birthing people in California. METHODS: We used linked vital statistics and hospital discharge records for births between 1997 and 2018 in California. SMM was defined by at least 1 of 21 potentially fatal conditions and lifesaving procedures. Rural-Urban Commuting Area codes were used to characterize census tract rurality dichotomously (2-category) and at 4 levels (4-category). Covariates included sociocultural-demographic, pregnancy-related, and neighborhood-level factors. We ran a series of mixed-effects logistic regression models with tract-level clustering, reporting risk ratios and 95% confidence intervals (CIs). We used the STROBE reporting guidelines. FINDINGS: Of 10,091,415 births, 1.1% had SMM. Overall, 94.3% of participants resided in urban/metropolitan and 5.7% in rural tracts (3.9% micropolitan, 0.9% small town, 0.8% rural). In 2-category models, the risk of SMM was 10% higher for birthing people in rural versus urban tracts (95% CI: 6%, 13%). In 4-category models, the risk of SMM was 16% higher in micropolitan versus metropolitan tracts (95% CI: 12%, 21%). CONCLUSION: The observed rurality and SMM relationship was driven by living in a micropolitan versus metropolitan tract. Increased risk may result from resource access inequities within suburban areas. Our findings demonstrate the importance of considering rurality at a subcounty level to understand locality-related inequities in the risk of SMM.
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OBJECTIVE: To determine the association of Spanish as a primary language for a family with the health outcomes of Hispanic infants with very low birth weight (VLBW, <1500g). STUDY DESIGN: Data from the California Perinatal Quality Care Collaborative (CPQCC) linked to hospital discharge records were analyzed. Hispanic infants with VLBW born between 2009 and 2018 with a primary language of English or Spanish were included. Outcomes selected were hypothesized to be sensitive to language barriers. Multivariable logistic regression models and mixed models estimated associations between language and outcomes. RESULTS: Of 18â364 infants meeting inclusion criteria, 27% (n = 4976) were born to families with Spanish as a primary language. In unadjusted analyses, compared with infants of primarily English-speaking families, these infants had higher odds of hospital readmission within 1 year (OR 1.11 [95% CI 1.02-1.21]), higher odds to receive human milk at discharge (OR 1.32 [95% CI 1.23-1.42]), and lower odds of discharge home with oxygen (OR 0.83 [95% CI 0.73-0.94]). In multivariable analyses, odds of readmission and home oxygen remained significant when adjusting for infant but not maternal and hospital characteristics. Higher odds for receipt of any human milk at discharge were significant in all models. Remaining outcomes did not differ between groups. CONCLUSIONS: Significant differences exist between Hispanic infants with VLBW of primarily Spanish-vs English-speaking families. Exploration of strategies to prevent readmissions of infants of families with Spanish as a primary language is warranted.
Subject(s)
Infant, Very Low Birth Weight , Milk, Human , Infant, Newborn , Female , Pregnancy , Humans , Infant , Logistic Models , Hispanic or Latino , CaliforniaABSTRACT
OBJECTIVE: The frequency of intrahepatic cholestasis of pregnancy (ICP) peaks during the third trimester of pregnancy when plasma progesterone levels are the highest. Furthermore, twin pregnancies are characterized by higher progesterone levels than singletons and have a higher frequency of cholestasis. Therefore, we hypothesized that exogenous progestogens administered for reducing the risk of spontaneous preterm birth may increase the risk of cholestasis. Utilizing the large IBM MarketScan Commercial Claims and Encounters Database, we investigated the frequency of cholestasis in patients treated with vaginal progesterone or intramuscular 17α-hydroxyprogesterone caproate for the prevention of preterm birth. STUDY DESIGN: We identified 1,776,092 live-born singleton pregnancies between 2010 and 2014. We confirmed second and third trimester administration of progestogens by cross-referencing the dates of progesterone prescriptions with the dates of scheduled pregnancy events such as nuchal translucency scan, fetal anatomy scan, glucose challenge test, and Tdap vaccination. We excluded pregnancies with missing data regarding timing of scheduled pregnancy events or progesterone treatment prescribed only during the first trimester. Cholestasis of pregnancy was identified based on prescriptions for ursodeoxycholic acid. We used multivariable logistic regression to estimate adjusted (for maternal age) odds ratios for cholestasis in patients treated with vaginal progesterone, and in patients treated with 17α-hydroxyprogesterone caproate compared with those not treated with any type of progestogen (the reference group). RESULTS: The final cohort consisted of 870,599 pregnancies. Among patients treated with vaginal progesterone during the second and third trimester, the frequency of cholestasis was significantly higher than the reference group (0.75 vs. 0.23%, adjusted odds ratio [aOR]: 3.16, 95% confidence interval [CI]: 2.23-4.49). In contrast, there was no significant association between 17α-hydroxyprogesterone caproate and cholestasis (0.27%, aOR: 1.12, 95% CI: 0.58-2.16) CONCLUSION: Using a robust dataset, we observed that vaginal progesterone but not intramuscular 17α-hydroxyprogesterone caproate was associated with an increased risk for ICP. KEY POINTS: · Previous studies have been underpowered to detect potential association between progesterone and ICP.. · Vaginal progesterone was significantly associated with ICP.. · Intramuscular 17α-hydroxyprogesterone was not associated with ICP..
Subject(s)
Cholestasis, Intrahepatic , Premature Birth , Pregnancy , Female , Humans , Infant, Newborn , Progesterone/adverse effects , 17 alpha-Hydroxyprogesterone Caproate , Progestins , Hydroxyprogesterones/adverse effects , Premature Birth/epidemiology , Premature Birth/prevention & control , Cholestasis, Intrahepatic/drug therapyABSTRACT
OBJECTIVE: Given that regionalization of extremely preterm births (EPTBs) is associated with improved infant outcomes, we assessed between-hospital variation in EPTB stratified by hospital level of neonatal care, and determined the proportion of variance explained by differences in maternal and hospital factors. STUDY DESIGN: We assessed 7,046,253 births in California from 1997 to 2011, using hospital discharge, birth, and death certificate data. We estimated the association between maternal and hospital factors and EPTB using multivariable regression, calculated hospital-specific EPTB frequencies, and estimated between-hospital variances and median odds ratios, stratified by hospital level of care. RESULT: Hospital frequencies of EPTB ranged from 0% to 2.5%. Between-hospital EPTB frequencies varied substantially, despite stratifying by hospital level of care and accounting for confounding factors. CONCLUSION: Our results demonstrate differences in EPTBs among hospitals with level 1 and 2 neonatal care, an area to target for future research and quality improvement.
Subject(s)
Premature Birth , Infant , Female , Infant, Newborn , Humans , Premature Birth/epidemiology , Infant, Extremely Premature , Hospitals , Odds RatioABSTRACT
OBJECTIVE: To assess whether readmission for hypertension by 6 weeks postpartum differed between patients discharged on nifedipine or labetalol. METHODS: This cohort study included patients with delivery admissions from 2006 to 2017 who were discharged from the hospital on nifedipine or labetalol and were included in a large, national adjudicated claims database. We identified patients' discharge medication based on filled outpatient prescriptions. We compared rates of hospital readmission for hypertension between patients discharged postpartum on labetalol alone, nifedipine alone, or combined nifedipine and labetalol. Patients with chronic hypertension without superimposed preeclampsia were excluded. Comparisons based on medication were performed using logistic regression models with adjustment for prespecified confounders. Comparisons were also stratified by hypertensive disorder of pregnancy severity. RESULTS: Among 1,582,335 patients overall, 14,112 (0.89%) were discharged postpartum on labetalol, 9,001 (0.57%) on nifedipine, and 1,364 (0.09%) on both medications. Postpartum readmissions for hypertension were more frequent for patients discharged on labetalol compared with nifedipine (641 patients vs 185 patients, 4.5% vs 2.1%, adjusted odds ratio [aOR] 1.63, 95% CI 1.43-1.85). Readmissions for hypertension were more frequent for patients discharged on labetalol compared with nifedipine for both mild (4.5% vs 2.7%, aOR 1.57, 95% CI 1.29-1.93) and severe hypertensive disorders of pregnancy (261 patients vs 72 patients, 5.7% vs 3.2%, aOR 1.63, 95% CI 1.43-1.85). Readmissions for hypertension were more frequent on combined nifedipine and labetalol compared with nifedipine (3.1% vs 2.1%), but the odds were lower after confounder adjustment (aOR 0.80, 95% CI 0.64-0.99). CONCLUSION: Postpartum discharge on labetalol was associated with increased risk of readmission for hypertension compared with discharge on nifedipine.
Subject(s)
Hypertension, Pregnancy-Induced , Hypertension , Labetalol , Pregnancy , Female , Humans , Labetalol/therapeutic use , Nifedipine/therapeutic use , Patient Discharge , Patient Readmission , Cohort Studies , Hypertension, Pregnancy-Induced/drug therapy , Hypertension, Pregnancy-Induced/epidemiology , Hypertension/drug therapy , Hypertension/epidemiology , Postpartum Period , Antihypertensive Agents/therapeutic useABSTRACT
BACKGROUND: Prepregnancy body mass index and gestational weight gain have been linked with severe maternal morbidity, suggesting that weight change between pregnancies may also play a role, as it does for neonatal outcomes. OBJECTIVE: This study assessed the association of changes in prepregnancy body mass index between 2 consecutive singleton pregnancies with the outcomes of severe maternal morbidity, stillbirth, and small- and large-for-gestational-age infants in the subsequent pregnancy. STUDY DESIGN: This observational study was based on birth records from 1,111,032 consecutive pregnancies linked to hospital discharge records in California (2007-2017). Interpregnancy body mass index change between the beginning of an index pregnancy and the beginning of the subsequent pregnancy was calculated from self-reported weight and height. Severe maternal morbidity was defined based on the Centers for Disease Control and Prevention index, including and excluding transfusion-only cases. We used multivariable log-binomial regression models to estimate adjusted risks, overall and stratified by prepregnancy body mass index at index birth. RESULTS: Substantial interpregnancy body mass index gain (≥4 kg/m2) was associated with severe maternal morbidity in crude but not adjusted analyses. Substantial interpregnancy body mass index loss (>2 kg/m2) was associated with increased risk of severe maternal morbidity (adjusted relative risk, 1.13; 95% confidence interval (1.07-1.19), and both substantial loss (adjusted relative risk, 1.11 [1.02-1.19]) and gain (≥4 kg/m2; adjusted relative risk, 1.09 [1.02-1.17]) were associated with nontransfusion severe maternal morbidity. Substantial loss (adjusted relative risk, 1.17 [1.05-1.31]) and gain (1.26 [1.14-1.40]) were associated with stillbirth. Body mass index gain was positively associated with large-for-gestational-age infants and inversely associated with small-for-gestational-age infants. CONCLUSION: Substantial interpregnancy body mass index changes were associated with modestly increased risk of severe maternal morbidity, stillbirth, and small- and large-for-gestational-age infants.
Subject(s)
Pregnancy Complications , Body Mass Index , Female , Gestational Age , Humans , Infant, Newborn , Infant, Small for Gestational Age , Pregnancy , Pregnancy Complications/diagnosis , Pregnancy Complications/epidemiology , Stillbirth/epidemiologyABSTRACT
BACKGROUND: Newborn oil massage is a widespread practice. Vigorous massage with potentially harmful products and forced removal of vernix may disrupt skin barrier integrity. Hospitalized, very-preterm infants treated with sunflower seed oil (SSO) have demonstrated improved growth but community-based data on growth and health outcomes are lacking. OBJECTIVES: We aimed to test whether SSO therapy enhances neonatal growth and reduces morbidity at the population level. METHODS: We conducted an open-label, controlled trial in rural Uttar Pradesh, India, randomly allocating 276 village clusters equally to comparison (usual care) and intervention comprised of promotion of improved massage practices exclusively with SSO, using intention-to-treat and per-protocol mixed-effects regression analysis. RESULTS: We enrolled 13,478 and 13,109 newborn infants in demographically similar intervention and comparison arms, respectively. Adherence to exclusive SSO increased from 22.6% of intervention infants enrolled in the first study quartile to 37.2% in the last quartile. Intervention infants gained significantly more weight, by 0.94 g · kg-1 · d-1 (95% CI: 0.07, 1.82 g · kg-1 · d-1, P = 0.03), than comparison infants by intention-to-treat analysis. Restricted cubic spline regression revealed the largest benefits in weight gain (2-4 g · kg-1 · d-1) occurred in infants weighing <2000 g at birth. Weight gain in intervention infants was higher by 1.31 g · kg-1 · d-1 (95% CI: 0.17, 2.46 g · kg-1 · d-1; P = 0.02) by per-protocol analysis. Morbidities were similar by intention-to-treat analysis but in per-protocol analysis rates of hospitalization and of any illness were reduced by 36% (OR: 0.64; 95% CI: 0.44, 0.94; P = 0.02) and 44% (OR: 0.56; 95% CI: 0.40, 0.77; P < 0.001), respectively, in treated infants. CONCLUSIONS: SSO therapy improved neonatal growth, and reduced morbidities when applied exclusively, across the facility-community continuum of care at the population level. Further research is needed to improve demand for recommended therapy inside hospital as well as in community settings, and to confirm these results in other settings.This trial was registered at www.isrctn.com as ISRCTN38965585 and http://ctri.nic.in as CTRI/2014/12/005282.
Subject(s)
Emollients , Infant, Premature , Humans , India/epidemiology , Infant , Infant, Newborn , Infant, Very Low Birth Weight , Morbidity , Sunflower OilABSTRACT
OBJECTIVE: This study examines comprehensive patient and process factors that influence breast milk use in the NICU setting. STUDY DESIGN: We examined the association of maternal, neonatal, and family factors and lactation support systems to identify gaps in breast milk use in a retrospective study of 865 infants born in 23-41 weeks gestation admitted to the NICU. RESULTS: Breast milk at discharge for all infants was 89.3%, for extremely preterm 82.3%, moderately preterm 91.4%, late preterm 86.5%, and term 92.7%. Prematurity (OR 0.31 [0.17-0.56]), low birth weight, morbidities, Black maternal race (OR 0.20 [0.07-0.57]) and public insurance (OR 0.54 [0.34-0.85]) were associated with decreased breast milk use. Early initiation of feeds was associated with increased breast milk use. CONCLUSIONS: There is a need to increase social as well as hospital support systems to address gaps in breast milk use in the NICU.
Subject(s)
Intensive Care Units, Neonatal , Milk, Human , Breast Feeding , Female , Humans , Infant , Infant, Newborn , Infant, Very Low Birth Weight , Lactation , Retrospective StudiesABSTRACT
OBJECTIVE: To evaluate severe maternal morbidity (SMM) among patients with epilepsy and patients without epilepsy. METHODS: We retrospectively examined SMM using linked birth certificate and maternal hospital discharge records in California between 2007 and 2012. Epilepsy present at delivery admission was the exposure and was subtyped into generalized, focal and other less specified, or unspecified. The outcomes were SMM and nontransfusion SMM from delivery up to 42 days' postpartum, identified using Centers for Disease Control and Prevention indicators. Multivariable logistic regression models were used to adjust for confounders, which were selected a priori. We also estimated the association between epilepsy and SMM independent of comorbidities by using a validated obstetric comorbidity score. Severe maternal morbidity indicators were then compared using the same multivariable logistic regression models. RESULTS: Of 2,668,442 births, 8,145 (0.3%) were to patients with epilepsy; 637 (7.8%) had generalized, 6,250 (76.7%) had focal or other less specified, and 1,258 (15.4%) had unspecified subtypes. Compared with patients without epilepsy, patients with epilepsy had greater odds of SMM (4.3% vs 1.4%, adjusted odds ratio [aOR] 2.91, 95% CI 2.61-3.24) and nontransfusion SMM (2.9% vs 0.7%, aOR 4.16, 95% CI 3.65-4.75). Epilepsy remained significantly associated with increased SMM and nontransfusion SMM after additional adjustment for the obstetric comorbidity score, though the effects were attenuated. When grouped by organ system, all SMM indicators were significantly more common among patients with epilepsy-most notably those related to hemorrhage and transfusion. CONCLUSION: Severe maternal morbidity was significantly increased in patients with epilepsy, and SMM indicators across all organ systems contributed to this.
Subject(s)
Epilepsy/epidemiology , Pregnancy Complications/epidemiology , Adult , Blood Transfusion/statistics & numerical data , California/epidemiology , Comorbidity , Epilepsy/mortality , Female , Hospitalization/statistics & numerical data , Humans , Logistic Models , Maternal Mortality , Morbidity , Odds Ratio , Postpartum Period , Pregnancy , Pregnancy Complications/mortality , Retrospective Studies , Severity of Illness Index , Young AdultABSTRACT
BACKGROUND: Hospitalized preterm infants with compromised skin barrier function treated topically with sunflower seed oil (SSO) have shown reductions in sepsis and neonatal mortality rate (NMR). Mustard oil and products commonly used in high-mortality settings may possibly harm skin barrier integrity and enhance risk of infection and mortality in newborn infants. We hypothesized that SSO therapy may reduce NMR in such settings. METHODS AND FINDINGS: This was a population-based, cluster randomized, controlled trial in 276 clusters in rural Uttar Pradesh, India. All newborn infants identified through population-based surveillance in the study clusters within 7 days of delivery were enrolled from November 2014 to October 2016. Exclusive, 3 times daily, gentle applications of 10 ml of SSO to newborn infants by families throughout the neonatal period were recommended in intervention clusters (n = 138 clusters); infants in comparison clusters (n = 138 clusters) received usual care, such as massage practice typically with mustard oil. Primary analysis was by intention-to-treat with NMR and post-24-hour NMR as the primary outcomes. Secondary analysis included per-protocol analysis and subgroup analyses for NMR. Regression analysis was adjusted for caste, first-visit weight, delivery attendant, gravidity, maternal age, maternal education, sex of the infant, and multiple births. We enrolled 13,478 (52.2% male, mean weight: 2,575.0 grams ± standard deviation [SD] 521.0) and 13,109 (52.0% male, mean weight: 2,607.0 grams ± SD 509.0) newborn infants in the intervention and comparison clusters, respectively. We found no overall difference in NMR in the intervention versus the comparison clusters [adjusted odds ratio (aOR) 0.96, 95% confidence interval (CI) 0.84 to 1.11, p = 0.61]. Acceptance of SSO in the intervention arm was high at 89.3%, but adherence to exclusive applications of SSO was 30.4%. Per-protocol analysis showed a significant 58% (95% CI 42% to 69%, p < 0.01) reduction in mortality among infants in the intervention group who were treated exclusively with SSO as intended versus infants in the comparison group who received exclusive applications of mustard oil. A significant 52% (95% CI 12% to 74%, p = 0.02) reduction in NMR was observed in the subgroup of infants weighing ≤1,500 g (n = 589); there were no statistically significant differences in other prespecified subgroup comparisons by low birth weight (LBW), birthplace, and wealth. No severe adverse events (SAEs) were attributable to the intervention. The study was limited by inability to mask allocation to study workers or participants and by measurement of emollient use based on caregiver responses and not actual observation. CONCLUSIONS: In this trial, we observed that promotion of SSO therapy universally for all newborn infants was not effective in reducing NMR. However, this result may not necessarily establish equivalence between SSO and mustard oil massage in light of our secondary findings. Mortality reduction in the subgroup of infants ≤1,500 g was consistent with previous hospital-based efficacy studies, potentially extending the applicability of emollient therapy in very low-birth-weight (VLBW) infants along the facility-community continuum. Further research is recommended to develop and evaluate therapeutic regimens and continuum of care delivery strategies for emollient therapy for newborn infants at highest risk of compromised skin barrier function. TRIAL REGISTRATION: ISRCTN Registry ISRCTN38965585 and Clinical Trials Registry-India (CTRI/2014/12/005282) with WHO UTN # U1111-1158-4665.
Subject(s)
Emollients/therapeutic use , Infant Mortality , Sunflower Oil/therapeutic use , Administration, Topical , Adult , Cluster Analysis , Female , Humans , India/epidemiology , Infant , Infant, Newborn , Infant, Premature , Male , Massage , Mustard Plant , Plant Oils/therapeutic use , Skin Cream/therapeutic use , Socioeconomic Factors , Sunflower Oil/administration & dosageABSTRACT
Severe maternal morbidity (SMM) is a composite outcome measure that indicates serious, potentially life-threatening maternal health problems. There is great interest in defining SMM using administrative data for surveillance and research. In the United States, one common way of defining SMM at the population level is an index developed by the Centers for Disease Control and Prevention. Modifications to this index (e.g., exclusion of maternal blood transfusion) have been proposed; some research defines SMM using an index introduced by Bateman et al. (Obstet Gynecol. 2013;122(5):957-965). Birth certificate data are also increasingly being used to define SMM. We compared commonly used US definitions of SMM among all California births (2007-2012) using the kappa (κ) statistic and other measures. We also evaluated agreement between maternal morbidity fields on the birth certificate as compared with health insurance claims data. Concordance between the 7 definitions of SMM analyzed was generally low (i.e., κ < 0.41 for 13 of 21 two-way comparisons). Low concordance was particularly driven by the presence/absence of transfusion and claims data versus birth certificate definitions. Low agreement between administrative data-based definitions of SMM highlights that results can be expected to differ between them. Further research on validity of SMM definitions, using more fine-grained data sources, is needed.
Subject(s)
Pregnancy Complications/epidemiology , Acute Disease/epidemiology , Adult , Birth Certificates , California/epidemiology , Centers for Disease Control and Prevention, U.S. , Female , Humans , Insurance Claim Review , Pregnancy , Pregnancy Complications/diagnosis , Terminology as Topic , United States/epidemiology , Young AdultABSTRACT
Interpregnancy interval (IPI) is associated with adverse perinatal outcomes, but its contribution to severe maternal morbidity (SMM) remains unclear. We examined the association between IPI and SMM, using data linked across sequential pregnancies to women in California during 1997-2012. Adjusting for confounders measured in the index pregnancy (i.e., the first in a pair of consecutive pregnancies), we estimated adjusted risk ratios for SMM related to the subsequent pregnancy. We further conducted within-mother comparisons and analyses stratified by parity and maternal age at the index pregnancy. Compared with an IPI of 18-23 months, an IPI of <6 months had the same risk for SMM in between-mother comparisons (adjusted risk ratio (aRR) = 0.96, 95% confidence interval (CI): 0.91, 1.02) but lower risk in within-mother comparisons (aRR = 0.76, 95% CI: 0.67, 0.86). IPIs of 24-59 months and ≥60 months were associated with increased risk of SMM in both between-mother (aRR = 1.18 (95% CI: 1.13, 1.23) and aRR = 1.76 (95% CI: 1.68, 1.85), respectively) and within-mother (aRR = 1.22 (95% CI: 1.11, 1.34) and aRR = 1.88 (95% CI: 1.66, 2.13), respectively) comparisons. The association between IPI and SMM did not vary substantially by maternal age or parity. In this study, longer IPI was associated with increased risk of SMM, which may be partly attributed to interpregnancy health.
Subject(s)
Birth Intervals/statistics & numerical data , Pregnancy Complications/epidemiology , Adult , California/epidemiology , Female , Humans , Longitudinal Studies , Maternal Age , Morbidity , Odds Ratio , Parity , Pregnancy , Pregnancy Complications/etiology , Risk Factors , Time FactorsABSTRACT
BACKGROUND: Birth hospital has recently emerged as a potential key contributor to disparities in severe maternal morbidity, but investigations on its contribution to racial and ethnic differences remain limited. OBJECTIVE: We leveraged statewide data from California to examine whether birth hospital explained racial and ethnic differences in severe maternal morbidity. STUDY DESIGN: This cohort study used data on all births at ≥20 weeks gestation in California (2007-2012). Severe maternal morbidity during birth hospitalization was measured using the Centers for Disease Control and Prevention index of having at least 1 of the 21 diagnoses and procedures (eg, eclampsia, blood transfusion, hysterectomy). Mixed-effects logistic regression models (ie, women nested within hospitals) were used to compare racial and ethnic differences in severe maternal morbidity before and after adjustment for maternal sociodemographic and pregnancy-related factors, comorbidities, and hospital characteristics. We also estimated the risk-standardized severe maternal morbidity rates for each hospital (N=245) and the percentage reduction in severe maternal morbidity if each group of racially and ethnically minoritized women gave birth at the same distribution of hospitals as non-Hispanic white women. RESULTS: Of the 3,020,525 women who gave birth, 39,192 (1.3%) had severe maternal morbidity (2.1% Black; 1.3% US-born Hispanic; 1.3% foreign-born Hispanic; 1.3% Asian and Pacific Islander; 1.1% white; 1.6% American Indian and Alaska Native, and Mixed-race referred to as Other). Risk-standardized rates of severe maternal morbidity ranged from 0.3 to 4.0 per 100 births across hospitals. After adjusting for covariates, the odds of severe maternal morbidity were greater among nonwhite women than white women in a given hospital (Black: odds ratio, 1.25; 95% confidence interval, 1.19-1.31); US-born Hispanic: odds ratio, 1.25; 95% confidence interval, 1.20-1.29; foreign-born Hispanic: odds ratio, 1.17; 95% confidence interval, 1.11-1.24; Asian and Pacific Islander: odds ratio, 1.26; 95% confidence interval, 1.21-1.32; Other: odds ratio, 1.31; 95% confidence interval, 1.15-1.50). Among the studied hospital factors, only teaching status was associated with severe maternal morbidity in fully adjusted models. Although 33% of white women delivered in hospitals with the highest tertile of severe maternal morbidity rates compared with 53% of Black women, birth hospital only accounted for 7.8% of the differences in severe maternal morbidity comparing Black and white women and accounted for 16.1% to 24.2% of the differences for all other racial and ethnic groups. CONCLUSION: In California, excess odds of severe maternal morbidity among racially and ethnically minoritized women were not fully explained by birth hospital. Structural causes of racial and ethnic disparities in severe maternal morbidity may vary by region, which warrants further examination to inform effective policies.
Subject(s)
Birth Setting/statistics & numerical data , Health Status Disparities , Healthcare Disparities/ethnology , Hospitals/statistics & numerical data , Obstetric Labor Complications/ethnology , Pregnancy Complications/ethnology , Puerperal Disorders/ethnology , Adult , Black or African American , Asian , Blood Transfusion/statistics & numerical data , California/epidemiology , Cerebrovascular Disorders/ethnology , Eclampsia/ethnology , Emigrants and Immigrants , Female , Gestational Age , Health Equity , Heart Failure/ethnology , Hispanic or Latino , Hospitals, Private/statistics & numerical data , Hospitals, Public/statistics & numerical data , Hospitals, Teaching/statistics & numerical data , Humans , Hysterectomy/statistics & numerical data , Indians, North American , Indigenous Peoples , Logistic Models , Middle Aged , Native Hawaiian or Other Pacific Islander , Obesity, Maternal , Pregnancy , Prenatal Care , Pulmonary Edema/ethnology , Respiration, Artificial/statistics & numerical data , Sepsis/ethnology , Severity of Illness Index , Shock/ethnology , Tracheostomy/statistics & numerical data , White People , Young AdultABSTRACT
OBJECTIVE: To determine the rates of high-risk infant follow-up (HRIF) attendance and the characteristics associated with follow-up among infants with hypoxic-ischemic encephalopathy (HIE) in California. STUDY DESIGN: Using population-based datasets, 1314 infants with HIE born in 2010-2016 were evaluated. The characteristics associated with follow-up were identified through multivariable logistic regression. RESULTS: 73.9% of infants attended HRIF by age 1. Follow-up rates increased and variation in follow-up by clinic decreased over time. Female infants; those born to African-American, single, less than college-educated, or publicly insured caregivers; and those referred to high-volume or regional programs had lower follow-up rates. In multivariable analysis, Asian and Pacific Islander race/ethnicity had lower odds of follow-up; infants with college- or graduate school-educated caregivers or referred to mid-volume HRIF programs had greater odds. CONCLUSION: Sociodemographic and program-level characteristics were associated with lack of follow-up among HIE infants. Understanding these characteristics may improve the post-discharge care of HIE infants.
Subject(s)
Hypoxia-Ischemia, Brain , Aftercare , California/epidemiology , Child , Female , Follow-Up Studies , Humans , Hypoxia-Ischemia, Brain/epidemiology , Infant , Patient DischargeABSTRACT
OBJECTIVE: To determine which outcome measures could detect early progression of disease in school-age children with mild cystic fibrosis (CF) lung disease over a two-year time interval utilizing chest computed tomography (CT) scores, quantitative CT air trapping (QAT), and spirometric measurements. METHODS: Thirty-six school-age children with mild CF lung disease (median [interquartile range] age 12 [3.7] years; percent predicted forced expiratory volume in 1 second (ppFEV1 ) 99 [12.5]) were evaluated by serial spirometer-controlled chest CT scans and spirometry at baseline, 3-month, 1- and 2-years. RESULTS: No significant changes were noted at 3-month for any variable except for decreased ppFEV1 . Mucus plugging score (MPS) and QATA1andA2 increased at 1- and 2-years. The bronchiectasis score (BS), and total score (TS) were increased at 2-year. All variables tested with the exception of bronchial wall thickness score, parenchymal score (PS), and ppFEV1 , were consistent with longitudinal worsening of lung disease. Multivariate analysis revealed baseline PS, baseline TS, and 1-year changes in BS and air trapping score were predictive of 2-year changes in BS. CONCLUSIONS: MPS and QATA1-A2 were the most sensitive indicators of progressive childhood CF lung disease. The 1-year change in the bronchiectasis score had the most positive predictive power for 2-year change in bronchiectasis.
Subject(s)
Bronchiectasis/etiology , Cystic Fibrosis/physiopathology , Disease Progression , Adolescent , Bronchi/anatomy & histology , Bronchi/diagnostic imaging , Child , Cystic Fibrosis/complications , Cystic Fibrosis/diagnosis , Female , Forced Expiratory Volume , Humans , Male , Mucus , Multivariate Analysis , Outcome Assessment, Health Care , Radiography, Thoracic , Sensitivity and Specificity , Spirometry , Tomography, X-Ray ComputedABSTRACT
OBJECTIVE: Identify clinical factors, transport characteristics and transport time intervals associated with clinical deterioration during neonatal transport in California. STUDY DESIGN: Population-based database was used to evaluate 47,794 infants transported before 7 days after birth from 2007 to 2016. Log binomial regression was used to estimate relative risks. RESULTS: 30.8% of infants had clinical deterioration. Clinical deterioration was associated with prematurity, delivery room resuscitation, severe birth defects, emergent transports, transports by helicopter and requests for delivery room attendance. When evaluating transport time intervals, time required for evaluation by the transport team was associated with increased risk of clinical deterioration. Modifiable transport intervals were not associated with increased risk. CONCLUSION: Our results suggest that high-risk infants are more likely to be unstable during transport. Coordination and timing of neonatal transport in California appears to be effective and does not seem to contribute to clinical deterioration despite variation in the duration of these processes.