Respiratory Distress Syndrome, NewbornNCT07344714
Predicting the Need for Prolonged Respiratory Support in Neonates Delivered in a Lower-Level NICU Setting
An observational study of Respiratory Distress Syndrome, Newborn and Respiratory Distress Syndrome in Premature Infant, run by Mayo Clinic at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 32 to 41 weeksHealthy volunteers can take part
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome in Premature Infant, Transient Tachypnea of the Newborn
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 41 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Neonates whose deliveries are attended by the Mayo Clinic neonatal resuscitation team.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Lavonne Liedl, LRT, 507-255-1828, liedl.lavonne@mayo.edu
William A. Carey, MD
About this study
Official title: Predicting Respiratory Distress Syndrome 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).
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.
- Conditions
- Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome in Premature Infant, Transient Tachypnea of the Newborn, Meconium Aspiration Syndrome, Pneumonia Neonatal, Hyaline Membrane Disease
- Medical subject headings
- Respiratory Distress Syndrome, Newborn, Transient Tachypnea of the Newborn, Meconium Aspiration Syndrome, Hyaline Membrane Disease, Pneumothorax
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 years
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).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start11 Mar 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome, NewbornStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William A. Carey, Mayo Clinic
- Investigators
- William A. Carey, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07344714
- Sponsor's protocol ID
- 24-002867
- Status last verified
- Mar 2026
- First submitted
- 7 Jan 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Respiratory Distress Syndrome in Neonates Delivered in a Lower-Level NICU Setting
- ClinicalTrials.gov ID
- NCT07344714
- Acronym / sponsor ID
- 24-002867
- Conditions
- Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome in Premature Infant, Transient Tachypnea of the Newborn, Meconium Aspiration Syndrome, Pneumonia Neonatal, Hyaline Membrane Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 11 Mar 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 32 to 41 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Neonates whose deliveries are attended by the Mayo Clinic neonatal resuscitation team.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Results publication: PubMed 41458086Leigh 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.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William A. Carey, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome, Newborn and Respiratory Distress Syndrome in Premature Infant, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lavonne M. Liedl, LRT (507-255-1828, liedl.lavonne@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of the algorithmic prediction of the need for prolonged respiratory support, defined as >6 hours of life. (time frame: 1 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07344714, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.