Predicting which newborns in a lower-level NICU will need extended breathing support

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

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
• Enrollment: 500 (estimated)
• Ages: 32 Weeks to 41 Weeks
• Sex: All
• Sponsor: Mayo Clinic (Academic / other)
• Locations: 1 site (Rochester, Minnesota)
• Trial ID: NCT07344714 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Rochester, Minnesota

• 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

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