Predicting the Need for Prolonged Respiratory Support in Neonates Delivered in a Lower-Level NICU Setting

Mayo Clinic500 enrolled

Overview

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).

The source of the gastric aspirates will be the medical waste generated through the routine care of neonates whose deliveries are attended by the Mayo Clinic neonatal resuscitation team.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome in Premature Infant Transient Tachypnea of the Newborn Meconium Aspiration Syndrome Pneumonia Neonatal Hyaline Membrane Disease Pneumothorax

Eligibility

Sex: ALLMin age: 32 WeeksMax age: 41 WeeksHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: • Both of the following: * 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. Exclusion Criteria: • Any one of the following: * 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.

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.

Time frame: 1 years

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).

Time frame: 2 years