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NCT Number: NCT07344714

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

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).

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Key information

Conditions

Respiratory Distress Syndrome, Newborn Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Hyaline Membrane Disease Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Meconium Aspiration Syndrome Pathological Conditions, Signs and Symptoms Pleural Diseases Pneumonia Neonatal Pneumothorax Pregnancy Complications Respiration Disorders Respiratory Distress Neonatal Respiratory Distress Syndrome Respiratory Distress Syndrome in Premature Infant Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Tachypnea Transient Tachypnea of the Newborn Urogenital Diseases

Age range

32 week–41 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Lavonne Liedl, LRT

CONTACT

[email protected]

507-255-1828

William A. Carey, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Performance of the algorithmic prediction of the need for prolonged respiratory support, defined as >6 hours of life.

    Time frame: 1 years

    Calculated sensitivity, specificity, positive- and negative-predictive values of the predicted outcomes compared to actual patient outcomes.

  2. Accuracy of algorithmic prediction of negative cases of Respiratory Distress Syndrome

    Time frame: 2 years

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Lavonne M. Liedl, LRT

CONTACT

[email protected]

507-255-1828

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 15, 2026
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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