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

NCT07344714 | Recruiting

• 1 other identifier: 24-002867
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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).

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; Respiratory Distress Neonatal

Outcome Measures

Primary Outcomes (2)

• 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

Eligibility Criteria

• Age: 32 Weeks - 41 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonates whose deliveries are attended by the Mayo Clinic neonatal resuscitation team.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 41458086 RESULT

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn; Transient Tachypnea of the Newborn; Meconium Aspiration Syndrome; Hyaline Membrane Disease; Pneumothorax

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Tachypnea; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Injury; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pleural Diseases

Study Officials

• William A. Carey, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lavonne M. Liedl, LRT

CONTACT

507-255-1828; liedl.lavonne@mayo.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 15, 2026
• Study Start: March 11, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)