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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | 2 years |
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Inclusion Criteria:
Both of the following:
Exclusion Criteria:
Any one of the following:
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Neonates whose deliveries are attended by the Mayo Clinic neonatal resuscitation team.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lavonne M. Liedl, LRT | Contact | 507-255-1828 | liedl.lavonne@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| William A. Carey, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41458086 | Result | Leigh BC, Liedl LM, Amsbaugh AL, Carey WA. Spectral analysis of gastric aspirates obtained shortly after birth predicts the need for prolonged respiratory support in neonates in a development cohort. Front Pediatr. 2025 Dec 11;13:1686794. doi: 10.3389/fped.2025.1686794. eCollection 2025. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D012127 | Respiratory Distress Syndrome, Newborn |
| D059245 | Transient Tachypnea of the Newborn |
| D008471 | Meconium Aspiration Syndrome |
| D006819 | Hyaline Membrane Disease |
| D011030 | Pneumothorax |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D059246 | Tachypnea |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D055370 | Lung Injury |
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D010995 | Pleural Diseases |
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