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

Predicting Respiratory Distress Syndrome in Neonates Delivered in a Lower-Level NICU Setting

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07344714

Enrollment

500

Registered

2026-01-15

Start date

2026-03-11

Completion date

2026-12-31

Last updated

2026-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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).

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

32 Weeks to 41 Weeks

Healthy volunteers

Yes

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. * Neonates with other identifiable causes of respiratory distress including pneumothorax, meconium aspiration syndrome, or pneumonia.

Design outcomes

Primary

Measure	Time frame	Description
Performance of the algorithmic prediction of the need for prolonged respiratory support, defined as >6 hours of life.	1 years	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	2 years	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).

Countries

United States

Contacts

CONTACTLavonne M. Liedl, LRT

liedl.lavonne@mayo.edu507-255-1828

PRINCIPAL_INVESTIGATORWilliam A. Carey, MD

Mayo Clinic

Outcome results