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Clinical Trials, and HPO
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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug688 | CT-P59 Wiki | 0.58 |
| drug2093 | Mother Provides MOM Wiki | 0.58 |
| drug2803 | Randomized to Delayed Cord Clamping at birth Wiki | 0.58 |
Navigate: Correlations HPO
There are 3 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 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 weeksAlphabetical 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