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1.
Am J Obstet Gynecol ; 2024 Apr 03.
Artigo em Inglês | MEDLINE | ID: mdl-38580044

RESUMO

BACKGROUND: Hypoxic-ischemic encephalopathy contributes to morbidity and mortality among neonates ≥36 weeks of gestation. Evidence of preventative antenatal treatment is limited. Magnesium sulfate has neuroprotective properties among preterm fetuses. Hypertensive disorders of pregnancy are a risk factor for hypoxic-ischemic encephalopathy, and magnesium sulfate is recommended for maternal seizure prophylaxis among patients with preeclampsia with severe features. OBJECTIVE: (1) Determine trends in the incidence of hypertensive disorders of pregnancy, antenatal magnesium sulfate, and hypoxic-ischemic encephalopathy; (2) evaluate the association between hypertensive disorders of pregnancy and hypoxic-ischemic encephalopathy; and (3) evaluate if, among patients with hypertensive disorders of pregnancy, the odds of hypoxic-ischemic encephalopathy is mitigated by receipt of antenatal magnesium sulfate. STUDY DESIGN: We analyzed a prospective cohort of live births ≥36 weeks of gestation between 2012 and 2018 within the California Perinatal Quality Care Collaborative registry, linked with the California Department of Health Care Access and Information files. We used Cochran-Armitage tests to assess trends in hypertensive disorders, encephalopathy diagnoses, and magnesium sulfate utilization and compared demographic factors between patients with or without hypertensive disorders of pregnancy or treatment with magnesium sulfate. Hierarchical logistic regression models were built to explore if hypertensive disorders of pregnancy were associated with any severity and moderate/severe hypoxic-ischemic encephalopathy. Separate hierarchical logistic regression models were built among those with hypertensive disorders of pregnancy to evaluate the association of magnesium sulfate with hypoxic-ischemic encephalopathy. RESULTS: Among 44,314 unique infants, the diagnosis of hypoxic-ischemic encephalopathy, maternal hypertensive disorders of pregnancy, and the use of magnesium sulfate increased over time. Compared with patients with hypertensive disorders of pregnancy alone, patients with hypertensive disorders treated with magnesium sulfate represented a high-risk population. They were more likely to be publicly insured, born between 36 and 38 weeks of gestation, be small for gestational age, have lower Apgar scores, require a higher level of resuscitation at delivery, have prolonged rupture of membranes, experience preterm labor and fetal distress, and undergo operative delivery (all P<.002). Hypertensive disorders of pregnancy were associated with hypoxic-ischemic encephalopathy (adjusted odds ratio, 1.26 [95% confidence interval, 1.13-1.40]; P<.001) and specifically moderate/severe hypoxic-ischemic encephalopathy (adjusted odds ratio, 1.26 [95% confidence interval, 1.11-1.42]; P<.001). Among patients with hypertensive disorders of pregnancy, treatment with magnesium sulfate was associated with 29% reduction in the odds of neonatal hypoxic-ischemic encephalopathy (adjusted odds ratio, 0.71 [95% confidence interval, 0.52-0.97]; P=.03) and a 37% reduction in the odds of moderate/severe neonatal hypoxic-ischemic encephalopathy (adjusted odds ratio, 0.63 [95% confidence interval, 0.42-0.94]; P=.03). CONCLUSION: Hypertensive disorders of pregnancy are associated with hypoxic-ischemic encephalopathy and, specifically, moderate/severe disease. Among people with hypertensive disorders, receipt of antenatal magnesium sulfate is associated with a significant reduction in the odds of hypoxic-ischemic encephalopathy and moderate/severe disease in a neonatal cohort admitted to neonatal intensive care unit at ≥36 weeks of gestation. The findings of this observational study cannot prove causality and are intended to generate hypotheses for future clinical trials on magnesium sulfate in term infants.

2.
Paediatr Perinat Epidemiol ; 38(5): 435-439, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38514907

RESUMO

BACKGROUND: The 10th revision of the International Classification of Diseases, Clinical Modification (ICD-10) includes diagnosis codes for placenta accreta spectrum for the first time. These codes could enable valuable research and surveillance of placenta accreta spectrum, a life-threatening pregnancy complication that is increasing in incidence. OBJECTIVE: We sought to evaluate the validity of placenta accreta spectrum diagnosis codes that were introduced in ICD-10 and assess contributing factors to incorrect code assignments. METHODS: We calculated sensitivity, specificity, positive predictive value and negative predictive value of the ICD-10 placenta accreta spectrum code assignments after reviewing medical records from October 2015 to March 2020 at a quaternary obstetric centre. Histopathologic diagnosis was considered the gold standard. RESULTS: Among 22,345 patients, 104 (0.46%) had an ICD-10 code for placenta accreta spectrum and 51 (0.23%) had a histopathologic diagnosis. ICD-10 codes had a sensitivity of 0.71 (95% CI 0.56, 0.83), specificity of 0.98 (95% CI 0.93, 1.00), positive predictive value of 0.61 (95% CI 0.48, 0.72) and negative predictive value of 1.00 (95% CI 0.96, 1.00). The sensitivities of the ICD-10 codes for placenta accreta spectrum subtypes- accreta, increta and percreta-were 0.55 (95% CI 0.31, 0.78), 0.33 (95% CI 0.12, 0.62) and 0.56 (95% CI 0.31, 0.78), respectively. Cases with incorrect code assignment were less morbid than cases with correct code assignment, with a lower incidence of hysterectomy at delivery (17% vs 100%), blood transfusion (26% vs 75%) and admission to the intensive care unit (0% vs 53%). Primary reasons for code misassignment included code assigned to cases of occult placenta accreta (35%) or to cases with clinical evidence of placental adherence without histopatholic diagnostic (35%) features. CONCLUSION: These findings from a quaternary obstetric centre suggest that ICD-10 codes may be useful for research and surveillance of placenta accreta spectrum, but researchers should be aware of likely substantial false positive cases.


Assuntos
Classificação Internacional de Doenças , Placenta Acreta , Humanos , Placenta Acreta/diagnóstico , Placenta Acreta/epidemiologia , Feminino , Gravidez , Adulto , Sensibilidade e Especificidade , Estudos Retrospectivos , Valor Preditivo dos Testes , Reprodutibilidade dos Testes
3.
Curr Allergy Asthma Rep ; 24(6): 303-315, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38639896

RESUMO

PURPOSE OF REVIEW: Based on shared decision-making (SDM) principles, a decision aid was previously developed to help patients, their caregivers, and physicians decide which peanut allergy management approach best suits them. This study refined the decision aid's content to better reflect patients' and caregivers' lived experience. RECENT FINDINGS: Current standard of care for peanut allergy is avoidance, although peanut oral immunotherapy has been approved by the Food and Drug Administration for use in patients 4-17 years old. An advisory board of allergy therapy experts (n = 3) and patient advocates (n = 3) informed modifications to the decision aid. The revised tool underwent cognitive debriefing interviews (CDIs) among adolescents (12-17 years old) with peanut allergy and caregivers of patients 4-17 years old with peanut allergy to evaluate its relevance, understandability, and usefulness. The 20 CDI participants understood the information presented in the SDM tool and reported it was important and relevant. Some revisions were made based on participant feedback. Results support content validity of the Peanut Allergy Treatment SDM Tool.


Assuntos
Tomada de Decisão Compartilhada , Hipersensibilidade a Amendoim , Humanos , Hipersensibilidade a Amendoim/terapia , Hipersensibilidade a Amendoim/imunologia , Adolescente , Criança , Pré-Escolar , Feminino , Masculino , Técnicas de Apoio para a Decisão , Cuidadores/psicologia , Dessensibilização Imunológica/métodos , Arachis/imunologia
4.
BMC Pregnancy Childbirth ; 24(1): 366, 2024 May 15.
Artigo em Inglês | MEDLINE | ID: mdl-38750438

RESUMO

BACKGROUND: The potential effect modification of sleep on the relationship between anxiety and elevated blood pressure (BP) in pregnancy is understudied. We evaluated the relationship between anxiety, insomnia, and short sleep duration, as well as any interaction effects between these variables, on BP during pregnancy. METHODS: This was a prospective pilot cohort of pregnant people between 23 to 36 weeks' gestation at a single institution between 2021 and 2022. Standardized questionnaires were used to measure clinical insomnia and anxiety. Objective sleep duration was measured using a wrist-worn actigraphy device. Primary outcomes were systolic (SBP), diastolic (DBP), and mean (MAP) non-invasive BP measurements. Separate sequential multivariable linear regression models fit with generalized estimating equations (GEE) were used to separately assess associations between anxiety (independent variable) and each BP parameter (dependent variables), after adjusting for potential confounders (Model 1). Additional analyses were conducted adding insomnia and the interaction between anxiety and insomnia as independent variables (Model 2), and adding short sleep duration and the interaction between anxiety and short sleep duration as independent variables (Model 3), to evaluate any moderating effects on BP parameters. RESULTS: Among the 60 participants who completed the study, 15 (25%) screened positive for anxiety, 11 (18%) had subjective insomnia, and 34 (59%) had objective short sleep duration. In Model 1, increased anxiety was not associated with increases in any BP parameters. When subjective insomnia was included in Model 2, increased DBP and MAP was significantly associated with anxiety (DBP: ß 6.1, p = 0.01, MAP: ß 6.2 p < 0.01). When short sleep was included in Model 3, all BP parameters were significantly associated with anxiety (SBP: ß 9.6, p = 0.01, DBP: ß 8.1, p < 0.001, and MAP: ß 8.8, p < 0.001). No moderating effects were detected between insomnia and anxiety (p interactions: SBP 0.80, DBP 0.60, MAP 0.32) or between short sleep duration and anxiety (p interactions: SBP 0.12, DBP 0.24, MAP 0.13) on BP. CONCLUSIONS: When including either subjective insomnia or objective short sleep duration, pregnant people with anxiety had 5.1-9.6 mmHg higher SBP, 6.1-8.1 mmHg higher DBP, and 6.2-8.8 mmHg higher MAP than people without anxiety.


Assuntos
Ansiedade , Pressão Sanguínea , Distúrbios do Início e da Manutenção do Sono , Humanos , Feminino , Gravidez , Projetos Piloto , Estudos Prospectivos , Adulto , Pressão Sanguínea/fisiologia , Distúrbios do Início e da Manutenção do Sono/psicologia , Distúrbios do Início e da Manutenção do Sono/epidemiologia , Sono/fisiologia , Complicações na Gravidez/psicologia , Inquéritos e Questionários , Actigrafia
5.
Fetal Diagn Ther ; : 1-8, 2024 Jun 06.
Artigo em Inglês | MEDLINE | ID: mdl-38843783

RESUMO

INTRODUCTION: Fetal magnetic resonance imaging (MRI) lung volume nomograms are increasingly used to prognosticate neonatal outcomes in fetuses with suspected pulmonary hypoplasia. However, pregnancies complicated by fetal anomalies associated with pulmonary hypoplasia may also be complicated by fetal growth restriction (FGR). If a small lung volume is suspected in such cases, it is often unclear whether the lungs are "small" because of underlying lung pathology, or small fetal size. Existing MRI lung volume nomograms have mostly been stratified by gestational age (GA), rather than estimated fetal weight (EFW). Therefore, we aimed to develop a novel fetal lung volume nomogram stratified by EFW. METHODS: Consecutive fetal MRIs performed at a quaternary medical center from 2019 to 2021 were analyzed. MRIs performed due to fetal lung anomalies and cases with FGR were excluded. All MRIs were performed without IV contrast on GE 3 or 1.5 Tesla scanners (GE Healthcare). Images were reviewed by three experienced fetal radiologists. Freehand ROI in square centimeter was drawn around the contours of the lungs on consecutive slices from the apex to the base. The volume of the right, left and total lungs were calculated in mL. Lung volumes were plotted by both EFW and GA. RESULTS: Among 301 MRI studies performed during the study period, 170 cases met inclusion criteria and were analyzed. MRIs were performed between 19- and 38-week gestation, and a sonographic EFW was obtained within a mean of 2.9 days (SD ± 5.5 days, range 0-14 days) of each MRI. Nomograms stratified by both EFW and GA were created using 200 g. and weekly intervals respectively. A formula using EFW to predict total lung volume was calculated: LV = 0.07497804 EFW0.88276 (R2 = 0.87). CONCLUSIONS: We developed a novel fetal lung volume nomogram stratified by EFW. If validated, this nomogram may assist clinicians predict outcomes in cases of fetal pulmonary hypoplasia with concomitant FGR.

6.
Hypertension ; 81(8): 1716-1723, 2024 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-38881466

RESUMO

BACKGROUND: Treatment of chronic hypertension during pregnancy has been shown to reduce the risk of adverse perinatal outcomes. In this study, we examined the prevalence and treatment of chronic hypertension during pregnancy and assessed changes in these outcomes following the release of the updated 2017 hypertension guidelines of the American College of Cardiology and American Heart Association. METHODS: We analyzed the MerativeTM Marketscan® Research Database of United States commercial insurance claims from 2007 to 2021. We assessed the prevalence of chronic hypertension during pregnancy and oral antihypertensive medication use over time. We then performed interrupted time series analyses to evaluate changes in these outcomes. RESULTS: The prevalence of chronic hypertension steadily increased from 1.8% to 3.7% among 1 900 196 pregnancies between 2008 and 2021. Antihypertensive medication use among pregnant individuals with chronic hypertension was relatively stable (57%-60%) over the study period. The proportion of pregnant individuals with chronic hypertension treated with methyldopa or hydrochlorothiazide decreased (from 29% to 2% and from 11% to 5%, respectively), while the proportion treated with labetalol or nifedipine increased (from 19% to 42% and from 9% to 17%, respectively). The prevalence or treatment of chronic hypertension during pregnancy did not change following the 2017 American College of Cardiology and American Heart Association hypertension guidelines. CONCLUSIONS: The prevalence of chronic hypertension during pregnancy doubled between 2008 and 2021 in a nationwide cohort of individuals with commercial insurance. Labetalol replaced methyldopa as the most commonly used antihypertensive during pregnancy. However, only about 60% of individuals with chronic hypertension in pregnancy were treated with antihypertensive medications.


Assuntos
Anti-Hipertensivos , Humanos , Gravidez , Feminino , Estados Unidos/epidemiologia , Anti-Hipertensivos/uso terapêutico , Prevalência , Adulto , Hipertensão/epidemiologia , Hipertensão/tratamento farmacológico , Complicações Cardiovasculares na Gravidez/epidemiologia , Complicações Cardiovasculares na Gravidez/tratamento farmacológico , Hipertensão Induzida pela Gravidez/epidemiologia , Hipertensão Induzida pela Gravidez/tratamento farmacológico , Adulto Jovem , Doença Crônica
7.
Artigo em Inglês | MEDLINE | ID: mdl-38923943

RESUMO

Background: The frequency of cervical insufficiency differs among the major racial and ethnic groups, with limited data specific to Asian American and Native Hawaiian/Pacific Islander (AANHPI) subpopulations. We assessed cervical insufficiency diagnoses and related outcomes across 10 racial and ethnic groups, including disaggregated AANHPI subgroups, in a large population-based cohort. Study Design: We performed a retrospective cohort study of all singleton births between 20-42 weeks' gestation in California from 2007 to 2018. Logistic regression models were performed to estimate the odds of cervical insufficiency and, among people with cervical insufficiency, the odds of cerclage and preterm birth according to self-reported race and ethnicity. Results: Among 5,114,470 births, 38,605 (0.8%) had a diagnosis code for cervical insufficiency. Compared with non-Hispanic White people, non-Hispanic Black people had the highest odds of cervical insufficiency (adjusted odds ratio [aOR] 3.07; 95% confidence interval [CI], 2.97, 3.18), for cerclage placement and higher odds for preterm birth. Disaggregating AANHPI subgroups showed that Indian people had the highest odds (aOR 1.94; 95% CI, 1.82, 2.07) of cervical insufficiency and had significantly higher odds of cerclage without increased odds of preterm birth; Southeast Asian people had the highest odds of preterm birth. Conclusion: Within a large, diverse population-based cohort, non-Hispanic Black people experienced the highest rates of cervical insufficiency, and among those with cervical insufficiency, had among the highest rates of cerclage and preterm birth. Among AANHPI subgroups specifically, Indian people had the highest rates of cervical insufficiency and cerclage placement, without increased rates of preterm birth; Southeast Asian people had the highest rates of preterm birth, without increased rates of cerclage. Disaggregating AANHPI subgroups identifies important differences in obstetric risk factors and outcomes.

8.
PLoS One ; 19(8): e0305625, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-39088472

RESUMO

INTRODUCTION: Bedsharing is common but advised against by the American Academy of Pediatrics. It is unknown if breastfeeding physicians bedshare more or less than the general population. OBJECTIVES: To determine the prevalence of bedsharing among physicians, their reasons for bedsharing or not, and whether bedsharing was associated with a longer duration of breastfeeding. METHODS: An online survey was adapted from surveys administered by the Centers for Disease Control and Prevention. The survey was administered to physicians and medical students who birthed children from October 2020 through August 2021. Respondents were asked to report on a singleton birth, and questions centered around sleep practices and breastfeeding. Survival analysis was used to examine the association between bedsharing and breastfeeding duration. RESULTS: Of 546 respondents with bedsharing data, 68% reported some history of bedsharing, and 77% were in specialties that involved caring for pregnant people and/or infants. Those who bedshared breastfed an average of four months longer than those who never bedshared (18.08 versus 14.08 months p<0.001). The adjusted risk of breastfeeding cessation was markedly lower for those who bedshared compared to those who did not (Hazard Ratio 0.57, 95% Confidence Interval 0.45, 0.71). The primary reason for bedsharing was to breastfeed (73%); the primary reason for not bedsharing was safety concerns (92%). Among those who bedshared (n = 373), 52% did not inform their child's healthcare provider. CONCLUSIONS: Bedsharing is common among our sample of mainly breastfeeding physicians, including those who care for pregnant people and/or infants. It is also associated with a longer duration of breastfeeding, which has implications for population health. Practicing bedsharing implies cognitive dissidence and may affect how physicians counsel about bedsharing. Additionally, lack of disclosure of bedsharing practices has implications for practical guidance about having open non-judgmental conversations and may be a missed opportunity to counsel on bedsharing safety.


Assuntos
Aleitamento Materno , Médicos , Sono , Humanos , Aleitamento Materno/estatística & dados numéricos , Feminino , Médicos/estatística & dados numéricos , Médicos/psicologia , Inquéritos e Questionários , Masculino , Adulto , Pessoa de Meia-Idade , Lactente , Recém-Nascido , Leitos , Gravidez
9.
Obstet Gynecol ; 143(3): 459-462, 2024 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-38176017

RESUMO

A growing number of studies are using birth certificate data, despite data-quality concerns, to study maternal morbidity and associated disparities. We examined whether conclusions about the incidence of maternal morbidity, including Black-White disparities, differ between birth certificate data and hospitalization data. Using linked birth certificate and hospitalization data from California and Michigan for 2018 (N=543,469), we found that maternal morbidity measures using birth certificate data alone are substantially underreported and have poor validity. Furthermore, the degree of underreporting in birth certificate data differs between Black and White individuals and results in erroneous inferences about disparities. Overall, Black-White disparities were more modest in the birth certificate data compared with the hospitalization data. Birth certificate data alone are inadequate for studies of maternal morbidity and associated racial disparities.


Assuntos
Declaração de Nascimento , Saúde Materna , Morbidade , Alta do Paciente , Feminino , Humanos , Gravidez , Hospitais , Incidência , Negro ou Afro-Americano , Brancos
10.
Ann Epidemiol ; 97: 62-69, 2024 Jul 20.
Artigo em Inglês | MEDLINE | ID: mdl-39038746

RESUMO

PURPOSE: To compare the physical and mental health of sexual and gender minority (SGM) parents to SGM non-parents. METHODS: A cross-sectional analysis using 2018-2020 data from The PRIDE Study, a national longitudinal cohort of SGM adults. We used Poisson regression adjusted for age, gender, relationship status, race/ethnicity, household income, and education to assess the association between parental status and each outcome. RESULTS: Among 9625 SGM participants, 1460 (15 %) were parents. Older participants were more likely to be parents: 2% of participants aged 18-30, 18% aged 30-39, and 38% aged 40+ were parents. In adjusted analyses, parenthood was associated with greater depression, anxiety, and post-traumatic stress symptoms as well as ever cigarette smoking. Among individuals assigned female sex at birth, parents were twice as likely to have been diagnosed with pelvic inflammatory disease compared to non-parents. There was no association between parenthood status and alcohol use, substance use, diabetes, HIV, hypertension, or autism. CONCLUSIONS: In this national cohort of SGM adults, parenthood was associated with differences in physical and mental health measures. Understanding how parenthood influences the health and well-being of the estimated 3 million SGM parents in the US will help our health systems support diverse families.

11.
AJOG Glob Rep ; 4(3): 100357, 2024 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-38975047

RESUMO

Background: Maternal mortality in the United States is rising and many deaths are preventable. Emergencies, such as postpartum hemorrhage, occur less frequently in non-teaching, rural, and urban low-birth volume hospitals. There is an urgent need for accessible, evidence-based, and sustainable inter-professional education that creates the opportunity for clinical teams to practice their response to rare, but potentially devastating events. Objective: To assess the feasibility of virtual simulation training for the management of postpartum hemorrhage in low-to-moderate-volume delivery hospitals. Study design: The study occurred between December 2021 and March 2022 within 8 non-academic hospitals in the United States with low-to-moderate-delivery volumes, randomized to one of two models: direct simulation training and train-the-trainer. In the direct simulation training model, simulation faculty conducted a virtual simulation training program with participants. In the train-the-trainer model, simulation faculty conducted virtual lessons with new simulation instructors on how to prepare and conduct a simulation course. Following this training, the instructors led their own simulation training program at their respective hospitals. The direct simulation training participants and students trained by new instructors from the train-the-trainer program were evaluated with a multiple-choice questionnaire on postpartum hemorrhage knowledge and a confidence and attitude survey at 3 timepoints: prior to, immediately after, and at 3 months post-training. Paired t-tests were performed to assess for changes in knowledge and confidence within teaching models across time points. ANOVA was performed to test cross-sectionally for differences in knowledge and confidence between teaching models at each time point. Results: Direct simulation training participants (n=22) and students of the train-the-trainer instructors (n=18) included nurses, certified nurse midwives and attending physicians in obstetrics, family practice or anesthesiology. Mean pre-course knowledge and confidence scores were not statistically different between direct simulation participants and the students of the instructors from the train-the-trainer course (79%+/-13 versus 75%+/-14, respectively, P-value=.45). Within the direct simulation group, knowledge and confidence scores significantly improved from pre- to immediately post-training (knowledge score mean difference 9.81 [95% CI 3.23-16.40], P-value<.01; confidence score mean difference 13.64 [95% CI 6.79-20.48], P-value<.01), which were maintained 3-months post-training. Within the train-the-trainer group, knowledge and confidence scores immediate post-intervention were not significantly different compared with pre-course or 3-month post-course scores. Mean knowledge scores were significantly greater for the direct simulation group compared to the train-the-trainer group immediately post-training (89%+/-7 versus 74%+/-8, P-value<.01) and at 3-months (88%+/-7 versus 76%+/-12, P-value<.01). Comparisons between groups showed no difference in confidence and attitude scores at these timepoints. Both direct simulation participants and train-the-trainer instructors preferred virtual education, or a hybrid structure, over in-person education. Conclusion: Virtual education for obstetric simulation training is feasible, acceptable, and effective. Utilizing a direct simulation model for postpartum hemorrhage management resulted in enhanced knowledge acquisition and retention compared to a train-the-trainer model.

12.
JAMA Pediatr ; 178(4): 345-353, 2024 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-38407859

RESUMO

Importance: No approved treatment exists for allergen-specific immunoglobulin E (IgE)-mediated cow's milk allergy (CMA), a common childhood food allergy. Objective: To assess dose, efficacy, and safety of epicutaneous immunotherapy with Viaskin milk in children with IgE-mediated CMA. Design, Setting, and Participants: A phase 1/2, 2-part, randomized, double-blind, placebo-controlled dose-ranging clinical trial in children aged 2 to 17 years with IgE-mediated CMA was conducted between November 2014 through December 2017. It took place at 17 trial sites in the US and Canada. Current CMA was confirmed by double-blind, placebo-controlled food challenge at study entry. Part A assessed the short-term safety of 150 µg, 300 µg, or 500 µg of Viaskin milk; part B evaluated the efficacy and safety of the 3 doses vs placebo over 12 months of treatment. Of the 308 screened participants with physician-diagnosed CMA, 198 met eligibility criteria (including an eliciting dose 300 mg or less) and were randomized. Intervention: Safety of Viaskin milk (150-µg, 300-µg, or 500-µg doses) was evaluated over a 3-week period (part A). In part B, 180 additional participants were randomized to receive Viaskin milk at doses of 150 µg, 300 µg, or 500 µg or placebo (1:1:1:1) for 12 months. Main Outcomes and Measures: The primary outcome was the proportion of treatment responders, defined as a 10-fold or more increase in the cumulative reactive dose of cow's milk protein (reaching at least 144 mg) or a cumulative reactive dose of cow's milk protein at 1444 mg or more at the month 12 double-blind, placebo-controlled food challenge. Results: A total of 95.5% of the randomized participants (mean [SD] age, 8 [4.17] years; 124 of 198 were male [62.6%]) completed treatment. The highest response rate was observed in participants who received Viaskin milk at the 300-µg dose with 24 of 49 responders (49.0%) overall vs 16 of 53 responders (30.2%) in the placebo group (odds ratio, 2.19; 95% CI, 0.91-5.41; P = .09), highest in the 2 to 11 years age group (22 of 38 [57.9%] vs 13 of 40 [32.5%]; P = .04). Most treatment-emergent adverse events were mild or moderate application-site reactions. One participant in the 500-µg Viaskin milk dose group experienced treatment-related anaphylaxis. Conclusions and Relevance: In this randomized clinical trial, 12 months of daily epicutaneous immunotherapy with a dose of Viaskin milk at 300 µg was associated with a statistically significant treatment response in 2- to 11-year-old children with IgE-mediated CMA. Treatment-related anaphylaxis and treatment-related discontinuation rates were low. Further research is needed to explore Viaskin milk as a viable treatment option for children with IgE-mediated CMA. Trial Registration: ClinicalTrials.gov Identifier: NCT02223182.


Assuntos
Anafilaxia , Hipersensibilidade a Leite , Animais , Bovinos , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Masculino , Alérgenos , Imunoglobulina E , Imunoterapia , Hipersensibilidade a Leite/terapia , Proteínas do Leite
13.
J Food Allergy ; 2(1): 69-74, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-39022133

RESUMO

As the prevalence of immunoglobulin E (IgE)-mediated food allergy continues to increase without an imminent cure, prevention has become an urgent need. A breakthrough study that shows that early consumption of peanut can prevent the development of peanut allergy has led for a push in early interventions. Theories associated with the increasing prevalence of food allergy lend themselves to areas of potential intervention, e.g., age at time of food introduction, infant feeding practices, microbiome influences, diet composition, vitamin D deficiency, and increasing rates of eczema. This review focused on the available data from studies that investigated early interventions to decrease the risk of food allergy.

14.
Obstet Gynecol ; 143(1): e18-e19, 2024 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-38096558
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