Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT07344714

Conditions

Respiratory Distress Syndrome, Newborn

Respiratory Distress Syndrome in Premature Infant

Transient Tachypnea of the Newborn

Meconium Aspiration Syndrome

Pneumonia Neonatal

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT07344714

Start date

Mar 11, 2026

Status verified date

Mar, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Performance of the algorithmic prediction of the need for prolonged respiratory support, defined as >6 hours of life. [ Time Frame: 1 years ]
  • Accuracy of algorithmic prediction of negative cases of Respiratory Distress Syndrome [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Lavonne M. Liedl, LRT

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

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Lavonne Liedl, LRT

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

Principal Investigator:

William A. Carey, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-03-18.