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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age32-41
SponsorMayo Clinic

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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