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Predicting Respiratory Support Needs in Newborns

This study is looking at how to predict if newborn babies will need extra breathing support for more than six hours after birth. Researchers will analyze fluid from the stomachs of newborns, which is routinely collected after delivery. The goal is to see how well this analysis can predict the need for prolonged breathing support and also how accurately it can identify babies who will *not* develop respiratory distress syndrome (breathing problems). You might be able to join if your baby is born at 32 weeks gestational age or older, and their delivery is attended by the neonatal resuscitation team. The study is currently observational, meaning researchers are just watching and collecting information, not giving any new treatments. The status of recruitment is unclear.

Study design
This is an observational study with a planned enrollment of 500 neonates (newborns).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure the prediction of prolonged respiratory support at 1 year and the accuracy of predicting negative cases of Respiratory Distress Syndrome at 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07344714

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

Recruiting
Not specifiedAges 32–41Observational
Mayo Clinic
~500 participants
Updated 2026-03-18 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Performance of the algorithmic prediction of the need for prolonged respiratory support, defined as >6 hours of life.
Measured over 1 years
+1 more outcome measured

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

Explore related trials

Meconium Aspiration SyndromePneumoniaPneumothoraxRespiratory Distress SyndromeTransient Tachypnea of the Newborn

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • William A. Carey, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Lavonne M. Liedl, LRT
[email protected]
507-255-1828
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

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

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

  • Accuracy of algorithmic prediction of negative cases of Respiratory Distress Syndrome2 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).