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There is one clinical trial.
This prospective, randomized, controlled study evaluates the safety and efficacy of a preterm birth (PTB) prevention strategy versus standard of care pregnancy management to reduce the incidence of adverse pregnancy outcomes.
Description: Reduction in composite neonatal morbidity and mortality in the PTB Prevention arm versus the Control arm.
Measure: Neonatal morbidity/mortality Time: Through initial neonate discharge from hospital after birth for all neonates, assessed up to 180 days.Description: Reduction in length of neonatal hospital stay for admissions from time of birth up to initial neonatal hospital discharge home or neonatal death, whichever occurs first, in the PTB Prevention arm versus the Control arm.
Measure: Length of neonatal hospital stay Time: Through initial neonate discharge from hospital after birth for all neonates, assessed up to 180 days.Description: Reduction in all days spent in the neonatal intensive care unit (NICU) for neonates from time of birth up to discharge home or neonatal death, whichever occurs first, in the PTB Prevention arm versus the Control arm.
Measure: Length of NICU hospital stay for neonates reduction Time: Through initial neonate discharge from hospital after birth or until neonatal death, whichever occurs first, assessed up to 180 days.Description: Increase in duration of gestation in the PTB Prevention arm versus the Control arm.
Measure: Increase gestation Time: Gestational age at deliveryDescription: Reduction in occurrence of one or more major neonatal morbidities (MNM) with high likelihood of major chronic illness - cystic periventricular leukomalacia, grade 3 and 4 intraventricular hemorrhage, grade 3 or higher retinopathy of prematurity and/or bronchopulmonary dysplasia - in the PTB Prevention arm versus the Control arm.
Measure: Reduction in occurrence of one or more major neonatal morbidities Time: 3 year infant follow-upDescription: Reduction in all-cause cost of neonatal hospitalizations for all admissions from time of birth up to neonatal discharge in the PTB Prevention arm versus the Control arm.
Measure: Cost reduction of neonatal hospitalizations for all admissions Time: Birth up to neonatal discharge, assessed up to 180 daysDescription: Reduction in all-cause cost of neonatal hospitalizations, for NICU admissions from time of birth up to neonatal discharge in the PTB Prevention arm versus the Control arm.
Measure: Cost reduction of neonatal hospitalizations for NICU admissions Time: Birth up to neonatal discharge, assessed up to 180 daysDescription: Reduction in all-cause cost of neonatal hospitalizations, for PTB admissions from time of birth up to neonatal discharge in the PTB Prevention arm versus the Control arm.
Measure: Cost reduction of neonatal hospitalizations for PTB admissions Time: Birth up to neonatal discharge, assessed up to 180 daysDescription: Reduction in all-cause cost of neonatal hospitalizations from time of birth up to neonatal discharge for admissions of preterm births after spontaneous rupture of membranes or spontaneous onset of labor (sPTB), in the PTB Prevention arm versus the Control arm.
Measure: Cost reduction of neonatal hospitalizations for PTB admissions after sPTB Time: Birth up to neonatal discharge, assessed up to 180 daysDescription: Reduction in the rate of preterm birth <32 weeks of gestation in the PTB Prevention arm versus the Control arm.
Measure: Reduction in rate of preterm birth <32 weeks gestation Time: DeliveryDescription: Reduction in the rate of preterm birth <35 weeks of gestation in the PTB Prevention arm versus the Control arm
Measure: Reduction in rate of preterm birth <35 weeks gestation Time: DeliveryDescription: Reduction in the rate of preterm birth <37 weeks of gestation in the PTB Prevention arm versus the Control arm.
Measure: Reduction in rate of preterm birth <37 weeks gestation Time: DeliveryDescription: Reduction in the rate of preterm birth <32 weeks of gestation after spontaneous rupture of membranes or spontaneous onset of labor (sPTB), in the PTB Prevention arm versus the Control arm.
Measure: Reduction in rate of preterm birth <32 weeks gestation after sPTB Time: DeliveryDescription: Reduction in the rate of preterm birth <35 weeks of gestation after spontaneous rupture of membranes or spontaneous onset of labor (sPTB), in the PTB Prevention arm versus the Control arm.
Measure: Reduction in rate of preterm birth <35 weeks gestation after sPTB Time: DeliveryDescription: Reduction in the rate of preterm birth <37 weeks of gestation after spontaneous rupture of membranes or spontaneous onset of labor (sPTB), in the PTB Prevention arm versus the Control arm.
Measure: Reduction in rate of preterm birth <37 weeks gestation after sPTB Time: DeliveryDescription: Reduction in all days spent in the NICU for all NICU admissions of preterm neonates (<37 weeks, only PTB with NICU admission) from birth up to neonatal discharge to home or neonatal death, whichever occurs first, in the PTB Prevention arm versus the Control arm.
Measure: NICU days reduction/NICU admissions <37 weeks Time: Through initial neonatal discharge from hospital after birth or until neonatal death, whichever occurs first, up to 180 days of lifeDescription: Reduction in all days spent in the NICU for all NICU admissions of spontaneous preterm neonates (only sPTB with NICU admission) from birth up to neonatal discharge to home or neonatal death, whichever occurs first, in the PTB Prevention arm versus the Control arm.
Measure: NICU days reduction/NICU admissions of sPTB neonates with NICU admission Time: Through initial neonatal discharge from hospital after birth or until neonatal death, whichever occurs first, up to 180 days of lifeDescription: Reduction in all days spent in the NICU from birth up to neonatal discharge to home or neonatal death, whichever occurs first, for all preterm neonates (independent of NICU admission including zero-length stays for those not admitted), in the PTB Prevention arm versus the Control arm.
Measure: NICU days reduction/NICU admissions of all preterm neonates Time: Through initial neonatal discharge from hospital after birth or until neonatal death, whichever occurs first, up to 180 days of lifeDescription: Reduction in all days spent in the NICU from birth up to neonatal discharge to home or neonatal death, whichever occurs first, for all sPTB neonates (independent of NICU admission including zero-length stays for those not admitted), in the PTB Prevention arm versus the Control arm.
Measure: NICU days reduction/NICU admissions of sPTB neonates Time: Through initial neonatal discharge from hospital after birth or until neonatal death, whichever occurs first, up to 180 days of lifeDescription: Reduction in length of neonatal hospital stay from birth up to neonatal discharge home or neonatal death, whichever occurs first, for all preterm neonates (<37 weeks, all PTB), in the PTB Prevention arm versus the Control arm.
Measure: Preterm neonatal hospital stay reduction Time: Through initial neonatal discharge from hospital after birth or until neonatal death, whichever occurs first, up to 180 days of lifeDescription: Reduction in length of neonatal hospital stay from birth up to neonatal discharge home or neonatal death, whichever occurs first, for all preterm neonates (<37 weeks, all sPTB), in the PTB Prevention arm versus the Control arm.
Measure: Preterm neonatal hospital stay reduction for sPTB Time: Through initial neonatal discharge from hospital after birth or until neonatal death, whichever occurs first, up to 180 days of lifeDescription: Reduction in days of total hospital and NICU stay after readmission of infants after initial discharge home and within 180 days of life for all admissions, in the PTB Prevention arm versus the Control arm.
Measure: Neonatal hospital and NICU stay reduction after readmission for all admissions Time: From initial neonatal discharge to home (assessed up to 180 days of life) and within 180 days of life for those discharged prior to 180 days of lifeDescription: Reduction in days of total hospital and NICU stay after readmission of infants after initial discharge home and within 180 days of life for NICU admissions, in the PTB Prevention arm versus the Control arm.
Measure: Neonatal hospital and NICU stay reduction after readmission for NICU admissions Time: From initial neonatal discharge to home (assessed up to 180 days of life) and within 180 days of life for those discharged prior to 180 days of lifeDescription: Reduction in days of total hospital and NICU stay after readmission of infants after initial discharge home and within 180 days of life for PTB admissions, in the PTB Prevention arm versus the Control arm.
Measure: Neonatal hospital and NICU stay reduction after readmission for PTB admissions Time: From initial neonatal discharge to home (assessed up to 180 days of life) and within 180 days of life for those discharged prior to 180 days of lifeDescription: Reduction in days of total hospital and NICU stay after readmission of infants after initial discharge home and within 180 days of life for sPTB admissions, in the PTB Prevention arm versus the Control arm.
Measure: Neonatal hospital and NICU stay reduction after readmission for sPTB admissions Time: From initial neonatal discharge to home (assessed up to 180 days of life) and within 180 days of life for those discharged prior to 180 days of lifeDescription: Reduction in all-cause costs of hospital readmission of infants after initial discharge and within 180 days of life for all admissions, in the PTB Prevention arm versus the Control arm.
Measure: Hospital readmission cost reduction for all admissions Time: From initial neonatal discharge to home (assessed up to 180 days of life) and within 180 days of life for those discharged prior to 180 days of lifeDescription: Reduction in all-cause costs of hospital readmission of infants after initial discharge and within 180 days of life for NICU admissions, in the PTB Prevention arm versus the Control arm.
Measure: Hospital readmission cost reduction for NICU admissions Time: From initial neonatal discharge to home (assessed up to 180 days of life) and within 180 days of life for those discharged prior to 180 days of lifeDescription: Reduction in all-cause costs of hospital readmission of infants after initial discharge and within 180 days of life for PTB admissions, in the PTB Prevention arm versus the Control arm.
Measure: Hospital readmission cost reduction for PTB admissions Time: From initial neonatal discharge to home (assessed up to 180 days of life) and within 180 days of life for those discharged prior to 180 days of lifeDescription: Reduction in all-cause costs of hospital readmission of infants after initial discharge and within 180 days of life for sPTB admissions, in the PTB Prevention arm versus the Control arm.
Measure: Hospital readmission cost reduction for sPTB admissions Time: From initial neonatal discharge to home (assessed up to 180 days of life) and within 180 days of life for those discharged prior to 180 days of lifeDescription: Reduction in all-cause costs of hospital readmission of infants after initial discharge and within the first year of life for all admissions, in the PTB Prevention arm versus the Control arm.
Measure: Hospital readmission cost reduction for all admissions within first year of life Time: From initial neonatal discharge to home (assessed up to 180 days of life) and within first year of lifeDescription: Reduction in all-cause costs of hospital readmission of infants after initial discharge and within the first year of life for NICU admissions, in the PTB Prevention arm versus the Control arm.
Measure: Hospital readmission cost reduction within first year of life for NICU admissions Time: From initial neonatal discharge to home (assessed up to 180 days of life) and within first year of lifeDescription: Reduction in all-cause costs of hospital readmission of infants after initial discharge and within the first year of life for PTB admissions, in the PTB Prevention arm versus the Control arm.
Measure: Hospital readmission cost reduction within first year of life for PTB admissions Time: From initial neonatal discharge to home (assessed up to 180 days of life) and within first year of lifeDescription: Reduction in all-cause costs of hospital readmission of infants after initial discharge and within the first year of life for sPTB admissions, in the PTB Prevention arm versus the Control arm.
Measure: Hospital readmission cost reduction within first year of life for sPTB admissions Time: From initial neonatal discharge to home (assessed up to 180 days of life) and within first year of lifeDescription: Reduction in all-cause costs of hospital readmission of infants after initial discharge and within the first three years of life for all admissions, in the PTB Prevention arm versus the Control arm.
Measure: Hospital readmission cost reduction within first three years of life for all admissions Time: From initial neonatal discharge to home (assessed up to 180 days of life) and within first three years of lifeDescription: Reduction in all-cause costs of hospital readmission of infants after initial discharge and within the first three years of life for NICU admissions, in the PTB Prevention arm versus the Control arm.
Measure: Hospital readmission cost reduction within first three years of life for NICU admissions Time: From initial neonatal discharge to home (assessed up to 180 days of life) and within first three years of lifeDescription: Reduction in all-cause costs of hospital readmission of infants after initial discharge and within the first three years of life for PTB admissions, in the PTB Prevention arm versus the Control arm.
Measure: Hospital readmission cost reduction within first three years of life for PTB admissions Time: From initial neonatal discharge to home (assessed up to 180 days of life) and within first three years of lifeDescription: Reduction in all-cause costs of hospital readmission of infants after initial discharge and within the first three years of life for sPTB admissions, in the PTB Prevention arm versus the Control arm.
Measure: Hospital readmission cost reduction within first three years of life for sPTB admissions Time: From initial neonatal discharge to home (assessed up to 180 days of life) and within first three years of lifeDescription: Reduction in NICU admission rates in the immediate neonatal period prior to initial discharge home or neonatal death, whichever occurs first, in the PTB Prevention arm versus Control arm.
Measure: NICU admission rate reduction Time: Through initial neonatal discharge from hospital after birth or until neonatal death, whichever occurs first, assessed up to 180 daysDescription: Observation of the dependence of the composite neonatal morbidity and mortality index co-primary endpoint on severity of risk as defined by PreTRM® categorical test results and continuous risk score, both in comparison of the PTB Prevention arm versus the Control arm and with stratification of both arms by PreTRM® test result.
Measure: Neonatal morbidity and mortality index observation Time: Within one year of primary analysisDescription: Observation of the dependence of the length of neonatal hospital stay co-primary endpoint on severity of risk as defined by PreTRM® categorical test results and continuous risk score, both in comparison of the PTB Prevention arm versus the Control arm and with stratification of both arms by PreTRM® test result.
Measure: Neonatal hospital length of stay observation Time: Within one year of primary analysisDescription: Observation of the dependence of the NICU length of stay secondary endpoint on severity of risk as defined by PreTRM® categorical test results and continuous risk score, both in comparison of the PTB Prevention arm versus the Control arm and with stratification of both arms by PreTRM® test result.
Measure: NICU length of stay observation Time: Within one year of primary analysisDescription: Observation of the dependence of the duration of gestation secondary endpoint on severity of risk as defined by PreTRM® categorical test results and continuous risk score, both in comparison of the PTB Prevention arm versus the Control arm and with stratification of both arms by PreTRM® test result.
Measure: Duration of gestation observation Time: Within one year of primary analysisDescription: Observation of the dependence of the MNM exploratory endpoint on severity of risk as defined by PreTRM® categorical test results and continuous risk score, both in comparison of the PTB Prevention arm versus the Control arm and with stratification of both arms by PreTRM® test result.
Measure: Major neonatal morbidities observation Time: Within one year of primary analysisDescription: Observation of the dependence of the exploratory endpoint of dependence of NICU length of stay amongst preterm neonates on severity of risk as defined by PreTRM® categorical test results and continuous risk score, both in comparison of the PTB Prevention arm versus the Control arm and with stratification of both arms by PreTRM® test result.
Measure: NICU length of stay amongst preterm neonates observation Time: Within one year of primary analysisDescription: Observation of the dependence of the exploratory endpoint of dependence of hospital length of stay amongst preterm neonates on severity of risk as defined by PreTRM® categorical test results and continuous risk score, both in comparison of the PTB Prevention arm versus the Control arm and with stratification of both arms by PreTRM® test result.
Measure: Hospital length of stay amongst preterm neonates observation Time: Within one year of primary analysisDescription: Observation of the dependence of the preterm birth rate exploratory endpoint on severity of risk as defined by PreTRM® categorical test results and continuous risk score, both in comparison of the PTB Prevention arm versus the Control arm and with stratification of both arms by PreTRM® test result.
Measure: Preterm birth rate observation Time: Within one year of primary analysisDescription: Observation of the dependence of the exploratory endpoint of all-cause cost of neonatal hospitalization on severity of risk as defined by PreTRM® categorical test results and continuous risk score, both in comparison of the PTB Prevention arm versus the Control arm and with stratification of both arms by PreTRM® test result.
Measure: Neonatal hospitalization cost observation Time: Within one year of primary analysisDescription: Observation of the dependence of the exploratory endpoint of all-cause cost of neonatal hospitalization amongst preterm neonates on severity of risk as defined by PreTRM® categorical test results and continuous risk score, both in comparison of the PTB Prevention arm versus the Control arm and with stratification of both arms by PreTRM® test result.
Measure: Preterm neonatal hospitalization observation Time: Within one year of primary analysisDescription: Observation of the contribution of components of the intervention protocol, including consideration of consent and adherence, to the co-primary endpoint of composite neonatal morbidity and mortality index.
Measure: Intervention protocol observation/neonatal morbidity and mortality index Time: Within one year of primary analysisDescription: Observation of the contribution of components of the intervention protocol, including consideration of consent and adherence, to the co-primary endpoint of length of neonatal hospital stay.
Measure: Intervention protocol observation/length of neonatal hospital stay Time: Within one year of primary analysisDescription: Observation of the contribution of components of the intervention protocol, including consideration of consent and adherence, to the, secondary endpoint of length of NICU stay.
Measure: Intervention protocol observation/length of NICU stay Time: Within one year of primary analysisDescription: Observation of the contribution of components of the intervention protocol, including consideration of consent and adherence, to the secondary endpoint of duration of gestation.
Measure: Intervention protocol observation/duration of gestation Time: Within one year of primary analysisDescription: Observation of the contribution of components of the intervention protocol, including consideration of consent and adherence, to the MNM and exploratory endpoint.
Measure: Intervention protocol observation/major neonatal morbidities Time: Within one year of primary analysisDescription: Observation of the contribution of components of the intervention protocol, including consideration of consent and adherence, to the exploratory endpoint of length of NICU stay amongst preterm neonates.
Measure: Intervention protocol observation/length of NICU stay amongst preterm neonates Time: Within one year of primary analysisDescription: Observation of the contribution of components of the intervention protocol, including consideration of consent and adherence, to the exploratory endpoint of length of hospital stay amongst preterm neonates.
Measure: Intervention protocol observation/length of hospital stay amongst preterm neonates Time: Within one year of primary analysisDescription: Observation of the contribution of components of the intervention protocol, including consideration of consent and adherence, to the exploratory endpoint of preterm birth rate.
Measure: Intervention protocol observation/preterm birth rate Time: Within one year of primary analysisDescription: Observation of the contribution of components of the intervention protocol, including consideration of consent and adherence, to the exploratory endpoint of all-cause cost of neonatal hospitalization.
Measure: Intervention protocol observation/neonatal hospitalization Time: Within one year of primary analysisDescription: Observation of the contribution of components of the intervention protocol, including consideration of consent and adherence, to the exploratory endpoint of all-cause cost of neonatal hospitalization amongst preterm neonates.
Measure: Intervention protocol observation/neonatal hospitalization amongst preterm neonates Time: Within one year of primary analysisDescription: Observation of percent of patients with SARS-CoV-2 after enrollment, as measured by a positive FDA-approved diagnostic test or COVID-19 salient symptoms requiring evaluation in an emergency room (ER) or hospital setting, compared across demographic groups
Measure: COVID-19 Time: Within one year of primary analysisAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
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