Predicting which newborns in a lower-level NICU will need extended breathing support
Official title: Predicting Respiratory Distress Syndrome in Neonates Delivered in a Lower-Level NICU Setting
Run by Mayo Clinic · NCT07344714 · Data updated 2026-11-12
This project will test whether analyzing a newborn's stomach fluid right after birth can help predict which babies born at 32+ weeks and attended by the neonatal resuscitation team will need breathing support for more than six hours.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 32 Weeks to 41 Weeks |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Status | Recruiting |
| Started | March 11, 2026 |
| Main results expected | October 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | March 18, 2026 |
| Trial ID | NCT07344714 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are newborns delivered at 32 completed weeks gestation or older whose deliveries are attended by the neonatal resuscitation team and for whom routine gastric suctioning is performed, with parents who have not declined Minnesota Research Authorization.
✕Probably not a fit
Patients unlikely to benefit include infants born before 32 weeks, those with known or suspected congenital anomalies, those receiving only comfort measures, infants with other identified causes of respiratory distress (such as pneumothorax, meconium aspiration, or neonatal pneumonia), or those whose parents declined research authorization.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study collects gastric fluid that is routinely suctioned from newborns delivered at 32 completed weeks gestation or older when the Mayo Clinic neonatal resuscitation team is present. Samples are obtained from medical waste during standard post-delivery care and are analyzed for markers that might predict prolonged respiratory support (>6 hours of life). Infants with known or suspected congenital anomalies, comfort-only care plans, or other identifiable causes of respiratory distress (for example pneumothorax, meconium aspiration syndrome, or neonatal pneumonia) are excluded. The goal is to determine whether signatures in gastric aspirate correlate with the subsequent need for extended respiratory support so clinicians can better triage and manage newborns at delivery.
Why it matters
Potential benefit: If successful, the approach could help clinicians identify newborns at birth who are likely to need prolonged breathing support and target monitoring or early interventions accordingly.
How similar studies have gone: This is a relatively novel application; small observational studies have explored biomarkers in airway or gastric secretions for neonatal respiratory outcomes, but robust prospective validation is currently limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Mayo Clinic in Rochester
Rochester, Minnesota, United States Recruiting
Study contacts
- Principal investigator: William A. Carey, MD — Mayo Clinic
- Study coordinator: Lavonne M. Liedl, LRT
- Email: liedl.lavonne@mayo.edu
- Phone: 507-255-1828
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.