About this trial
The purpose of this study is to analyze the gastric fluid aspirated from the stomachs of neonates receiving routine post-delivery care to predict the need for prolonged respiratory support (\>6 hours of life).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Neonates born at 32 completed weeks gestational age or older whose deliveries are attended by the neonatal resuscitation team and for whom routine gastric suctioning is indicated
Neonates whose parents actively accepted or did not actively decline the Minnesota Research Authorization.
Disqualifiers
Neonates with known or suspected congenital anomalies
Neonates for whom only comfort measures are planned or possible at time of delivery
Neonates whose parents actively declined the Minnesota Research Authorization.
Neonates with other identifiable causes of respiratory distress including pneumothorax, meconium aspiration syndrome, or pneumonia.
Trial population
Neonates whose deliveries are attended by the Mayo Clinic neonatal resuscitation team.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Performance of the algorithmic prediction of the need for prolonged respiratory support, defined as >6 hours of life.
Calculated sensitivity, specificity, positive- and negative-predictive values of the predicted outcomes compared to actual patient outcomes.
Accuracy of algorithmic prediction of negative cases of Respiratory Distress Syndrome
Total proportion of true negatives as determined by the digital point-of-care device algorithm predicting no diagnosis of Respiratory Distress Syndrome and the clinician does not diagnosis Respiratory Distress Syndrome. Reported as a calculation of # true negatives / (# true negatives + # false negatives).
Sponsors and contacts
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