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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3264 | Randomized to Delayed Cord Clamping at birth Wiki | 0.45 |
| drug836 | Canakinumab Injection 300mg Wiki | 0.45 |
| drug4506 | hospitalization for premature birth Wiki | 0.45 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2447 | Multimodal intervention strategy Wiki | 0.45 |
| drug2477 | NICU Acquires MOM Wiki | 0.45 |
| drug1814 | Hydroxychloroquine in combination of Azithromycin Wiki | 0.45 |
| drug837 | Canakinumab Injection 600mg Wiki | 0.45 |
| drug2435 | Mother Provides MOM Wiki | 0.45 |
| drug3265 | Randomized to Umbilical Cord Milking at birth Wiki | 0.45 |
| drug4512 | hydroxychloroquine in combination with camostat mesylate Wiki | 0.45 |
| drug2998 | Placebos Wiki | 0.11 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D047928 | Premature Birth NIH | 1.00 |
| D007752 | Obstetric Labor, Premature NIH | 0.52 |
| D001724 | Birth Weight NIH | 0.45 |
| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There are 5 clinical trials
An extension of the PREMOD2 trial, the PREMOD2 Follow-Up trial will evaluate the neurodevelopmental outcomes at 22-26 months corrected age of preterm children who received UCM or DCC. This prospective multi-national randomized controlled trial (RCT) is a two-arm parallel non-inferiority design of two alternative approaches of treatment.
Description: Bayley Scales of Infant Development (BSID), 3rd or 4th Ed. Composite Score (cognitive 55-145, language 45-155, motor 45-155; higher scores are better)
Measure: Developmental Outcome Time: 22-26 months corrected gestational age (CGA). All assessments may be extended to 42 months CGA due to Covid-19 pandemic.Description: Defined having at least one of the following: a cognitive score <70, GMFCS greater or equal 2, blindness (vision <20/200), or hearing impairment interfering with the ability to communicate with amplification.
Measure: Moderate/Severe Neurodevelopmental Impairment Time: 22-26 months corrected gestational ageDescription: Defined having at least one of the following: a cognitive score 70-84, GMFCS =1, unilateral blindness (vision <20/200 in only one eye), or hearing impairment which does not interfere with the ability to communicate.
Measure: Mild Neurodevelopmental Impairment Time: 22-26 months corrected gestational ageDescription: The GMFCS is a validated system used to describe the severity of motor dysfunction. Scale measured from Level 0-5 with Level 0 being normal and Level 5 being the worst score. Measures ability to walk, sit, head control, voluntary movements and postures.
Measure: Gross Motor Function Classification System Scale (GMFCS) Time: 22-26 months corrected gestational ageDescription: Classified as None, Mild, Moderate or Severe based on GMFCS score; No CP = GMFCS Level 0, Mild CP = GMFCS Level 1, Moderate CP = GMFCS Levels 2-3, Severe CP = GMFCS Levels 4-5
Measure: Cerebral Palsy (CP) Time: 22-26 months corrected gestational ageDescription: Each domain is scored from 0 to 60, the higher score is better.
Measure: Developmental Outcomes assessed by Ages & Stages Questionnaire, 3rd ed. (ASQ-3) five domains: Communication, Gross motor, Fine motor, Problem solving and Personal-social in infants born between 23-32+6 weeks GA who received UCM or DCC. Time: 22-26 months corrected gestational ageDescription: BSID Cognitive, Language & Motor composite scores (cognitive 55-145, language 45-155, motor 45-155; higher scores are better) in infants 23-27 weeks GA and 28-32+6 weeks GA.
Measure: Developmental Outcomes in infants born at 23 -27 and 28-32 weeks GA who received UCM or DCC Time: 22-26 months corrected gestational ageDescription: ASQ-3 scores (0 to 60, the higher score is better) in infants 23-27 weeks GA and 28-32+6 weeks GA.
Measure: Developmental Outcomes in infants born at 23 -27 and 28-32 weeks GA who received UCM or DCC Time: 22-26 months corrected gestational ageDescription: Mild, moderate or severe impairment
Measure: Compare levels of developmental impairment as assessed by BSID-3 or 4 versus the ASQ-3 screening tool. Time: 22-26 months corrected gestational ageDescription: Any IVH grade from 1 to grade 4, higher grade is worse
Measure: Any grade intraventricular hemorrhage (IVH) in premature newborns 23 - 32+6 weeks GA who received UCM or DCC by mode of delivery (C-Section vs vaginal delivery) Time: From birth through hospital discharge, up to 6 months corrected gestational age (CGA)Description: Death
Measure: Death in premature newborns 23 - 32+6 weeks GA who received UCM or DCC by mode of delivery (C-Section vs vaginal delivery) Time: From birth through hospital discharge, up to 6 months corrected gestational age (CGA)Description: BSID Cognitive, Language & Motor composite scores (cognitive 55-145, language 45-155, motor 45-155; higher scores are better)
Measure: Compare neurodevelopmental outcomes from BSID assessments in newborns 23-32 weeks GA delivered by C-Section with those born by vaginal delivery receiving UCM or DCC. Time: 22-26 months corrected gestational ageDescription: ASQ-3 scores (0 to 60, the higher score is better).
Measure: Compare neurodevelopmental outcomes from ASQ assessments in newborns 23-32 weeks GA delivered by C-Section with those born by vaginal delivery receiving UCM or DCC. Time: 22-26 months corrected gestational ageDescription: Any grade IVH, from 1 to 4 (higher is worse)
Measure: Exploratory, hypothesis-generating Time: From birth through hospital discharge, up to 6 months corrected gestational age (CGA)Description: Hemoglobin or Hematocrit at 4 hours of age
Measure: Exploratory, hypothesis-generating Time: 4 hours of life +/- 2 hoursDescription: Delivery room interventions received: positive pressure ventilation, continuous positive airway pressure, intubation, chest compressions and medications
Measure: Exploratory, hypothesis-generating Time: In the first 10 minutes of lifeDescription: Blood pressures in the first 24 hours of life: on admission, 6, 12, 18 and 24 hours of life
Measure: Exploratory, hypothesis-generating Time: In the first 24 hours of lifeThis 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 analysisThis is a retrospective, observational study based on the consortium of the SafeBoosC-III randomised clinical trial. This study will evaluate if the number of admitted extremely preterm infants has decreased in the SafeBoosC-III departments during the global lockdown, and whether there is an association between the level of lockdown restrictions and change in the number of ELGAN admissions.
Description: The primary outcome will be the difference in the total number of ELGAN admissions in SafeBoosC-III departments during the peak three months of the COVID-19 pandemic in 2020 compared to the same three months period in 2019. The most rigorous three months of the COVID-19 pandemic will be a subjective definition by the local investigator, based on when the lockdown restrictions were strictest.
Measure: Number of ELGAN admissions during peak three months of COVID-19 compared to corresponding months in 2019 Time: 3 monthsDescription: The difference in the number of ELGAN admissions during the peak three months of the COVID-19 pandemic versus the same three months in 2019, within the following regions: North America: USA Northern Europe: Denmark, Norway Eastern Europe: Austria, Poland, Czech Republic, Ukraine, Turkey Western Europe: Germany, UK, Ireland, Switzerland, Belgium Southern Europe: Spain, Portugal, Italy, Greece Asia: India, China
Measure: Regional difference in ELGAN admissions during peak three months of COVID-19 compared to corresponding months in 2019 Time: 3 monthsDescription: Investigators will be asked to clarify how and where the information has been obtained from. Furthermore, investigators will be asked to classify the level of restrictions imposed upon the public, during the lockdown period, in a Likert scale format from 1-5.
Measure: Correlation between the level of lockdown restrictions and number of ELGAN admissions during peak three months of COVID-19 compared to corresponding months in 2019 Time: 3 monthsDescription: For the purpose of an exploratory analysis, we will ask investigators to rate the likelihood that restrictions outside or inside health institutions in their country/region, have led to non-admittance of ELGAN. Causes could be intrauterine death, or no transfer from place of birth
Measure: Likelihood of restrictions leading to non-admittance of ELGAN Time: 3 monthsIn the US, the burden of very low birth weight (VLBW; <1500 g) birth is borne disproportionately by black (non-Hispanic black/African American) mothers who are 2.2-2.6 times more likely than nonblack mothers to deliver VLBW infants. This disparity is amplified because black VLBW infants are significantly less likely to receive mother's own milk (MOM) feedings from birth until neonatal intensive care unit (NICU) discharge than nonblack infants, which adds to the lifelong burden of VLBW birth with increased risk of morbidities and greater costs. Pumping is associated with out-of-pocket and opportunity costs that are borne by mothers, unlike donor human milk and formula, which are paid for by NICUs. This innovative trial will determine the effectiveness of the intervention in reducing the disparity in MOM feedings and provide an economic analysis of the interventions, yielding critical data impacting generalizability and likelihood of implementation of results. The investigators hypothesize that mothers who receive intervention will have greater pumping volume and duration and their infants will be more likely to receive MOM at NICU discharge compared to mothers who receive standard of care lactation care and their infants.
Description: Determined from the last full day of hospitalization and categorized as "Yes" if the infant received any or exclusive MOM and "No" if the infant received only formula.
Measure: Receipt of MOM at NICU Discharge Time: Through study completion, an average of 10 weeksDescription: Determined from the entire hospitalization and categorized as "Yes" if the infant received any or exclusive MOM and "No" if the never received MOM during the hospitalization.
Measure: Receipt of any MOM Time: Through study completion, an average of 10 weeksDescription: Determined from the entire hospitalization and calculated as the number of days infant received any MOM.
Measure: Duration of MOM feedings Time: Through study completion, an average of 10 weeksDescription: Determined from the entire hospitalization and calculated as the total volume of MOM received by the infant.
Measure: Cumulative dose of MOM feedings Time: Through study completion, an average of 10 weeksDescription: Determined from the entire hospitalization and calculated as the number of days mother pumped MOM.
Measure: Duration of MOM pumped Time: Through study completion, an average of 10 weeksDescription: Determined from the entire hospitalization and calculated as the total volume of MOM pumped by the mother.
Measure: Volume of MOM pumped Time: Through study completion, an average of 10 weeksDescription: Costs borne by healthcare providers or third-party payers, including the cost of the hospital stay and donor human milk and formula costs.
Measure: Healthcare system costs Time: Through study completion, an average of 10 weeksDescription: Participant costs will be measured in dollars and will be the sum of opportunity costs (i.e., mother's time spent pumping (mothers in control group only), time off work to visit NICU), caregiving costs for other children or adults when mother or partner visits the NICU, transportation costs, lodging costs, and other out-of-pocket costs
Measure: Participant costs in US Dollars Time: Through study completion, an average of 10 weeksDescription: The costs of the intervention including milk pick-up, free provision of pumps, and opportunity costs payments for the intervention arm.
Measure: ReDiMOM Intervention Costs in US Dollars Time: Through study completion, an average of 10 weeksPreterm labor (PL) is the leading cause of hospitalization during pregnancy and premature birth the leading cause of fetal morbidity and mortality in France. PL is defined by regular and painful uterine contractions associated with a change in the cervix, between 22 and 36 weeks of gestation. It has been shown that the risk of spontaneous prematurity increases particularly in case of working over 40 hours per week, hard physically conditions, or prolonged daily transport time. Rest is one of the most efficient measure to prevent PL and should be proposed to all pregnant women, and combined with other therapies such as tocolysis or cerclage when needed. The very particular period of lockdown during the COVID-19 pandemic had pregnant women to drastically reduce their activity. They suspended their work and stayed home for various reasons such as pregnancy in progress, children at home, and also collective reasons such as teleworking or workplace closure. During the lockdown period from March 17th to May 11th 2020, fewer preterm labor and less spontaneous prematurity have been suspected by the neonatology and obstetrics teams throughout the Lorraine region. Our study aims to objectively confirm this observation. In this investigation we aim to find a relationship between lockdown, PL and spontaneous prematurity which would need to re-evaluate public health recommendations for pregnant women outside the lockdown.
Description: Number of prematurely born infants
Measure: Evaluate the impact of confinement on the rate of spontaneous prematurity at the Regional University Maternity Hospital of Nancy (MRUN) Time: baselineDescription: Number of infants born by vaginal delivery or cesarean section
Measure: Evaluate the impact of confinement on the type of prematurity rate: spontaneous or not Time: baselineDescription: Number of infants transferred from referring hospitals to the level III NICU for prematurity
Measure: Evaluate the impact of confinement on the outborn rate managed by the Regional Neonatal transport team for prematurity Time: baselineDescription: Diagnosis evaluation of prematurely born infants during lockdown period
Measure: Evaluate the type of prematurity over the period of confinement Time: baselineAlphabetical 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.
Drug Reports MeSH Reports HPO Reports