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RecruitingNCT07344714Updated Mar 18, 2026

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

An observational study in Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome in Premature Infant and Transient Tachypnea of the Newborn, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 32 Weeks to 41 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-18.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
32 Weeks to 41 Weeks
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
32 Weeks to 41 Weeks
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No
05

What researchers measure

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

06

Study locations

1 of 1 sites recruiting
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
    • Lavonne Liedl, LRT · Contact · liedl.lavonne@mayo.edu · 507-255-1828
    • William A. Carey, MD · Principal investigator
    Recruiting
07

References and documents

Publications

  • 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. PubMed 41458086 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07344714
Lead sponsor
Mayo Clinic
Responsible party
William A. Carey (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Jan 15, 2026
Start date
Mar 11, 2026
Primary completion
Oct 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Mar 18, 2026

Study contacts

Lavonne M. Liedl, LRT
Contact
liedl.lavonne@mayo.edu
507-255-1828
William A. Carey, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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