Respiratory Distress of NewbornNCT06140615
Lung Ultrasound - Prospective Study
A study testing Ultrasound in people with Respiratory Distress of Newborn, run by University of Wisconsin, Madison at 2 sites in United States.
Trial summary
The goal of this clinical trial is to determine whether lung ultrasound can predict extubation success in neonates with respiratory distress. Participants will undergo a lung ultrasound pre- and post-extubation. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Respiratory Distress of Newborn
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Dec 2023to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants born at UnityPoint Health Meriter Hospital and University of Minnesota admitted to the Neonatal Intensive Care Unit (NICU) with respiratory distress requiring intubation
- Meeting the extubation readiness criteria per the attending neonatologist
Who cannot join
- Known major congenital disease (chromosomal abnormality, heart disease, respiratory malformation)
- Neonates with parents that are less than 18 years old
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Unity-Point Health Meriter
Madison, Wisconsin, 53715
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: The Utility of Lung Ultrasound Scores to Determine Extubation Readiness in Neonates With Respiratory Distress on Mechanical Ventilation
The goal of this clinical trial is to determine whether lung ultrasound can predict extubation success in neonates with respiratory distress.
Participants will undergo a lung ultrasound pre- and post-extubation.
- Conditions
- Respiratory Distress of Newborn
- Being tested
- Ultrasound
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Ultrasound of lungs
| Study group | Role | What they receive |
|---|---|---|
| Lung ultrasound | Experimental | Participants undergo pre- and post-extubation lung ultrasound Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of lung ultrasound score to predict extubation success
Correlate the lung ultrasound score to the success of extubation, which is defined as remaining extubated for >72 hours. Ultrasound scores are measured on a 4-point scale (0=normal,3 = most abnormal).
Measured: 12 hours pre-extubation to 24 hours post extubation
Secondary outcomes (5)
Change in pre- and post-extubation lung ultrasound scores
Ultrasound scores are measured on a 4-point scale (0=normal,3 = most abnormal).
Measured: 12 hours pre-extubation to 24 hours post extubation
Time to re-intubation
Length of time from extubation to re-intubation.
Measured: Up to 72 hours post-intubation
Change in heart rate
Measure of heart rate before and after ultrasound procedure
Measured: 5 minutes before to 5 minutes after lung ultrasound
Change in respiratory rate
Measure of respiratory rate before and after ultrasound procedure
Measured: 5 minutes before to 5 minutes after lung ultrasound
Change in oxygen saturation
Measure of oxygen saturation before and after ultrasound procedure
Measured: 5 minutes before to 5 minutes after lung ultrasound
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2023
- Study start11 Dec 2023
- Primary completion1 Feb 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress of NewbornStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Meriter Foundation
- Responsible party
- Sponsor
- Investigators
- Adam S Bauer, MD, Principal investigator, Meriter Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140615
- Sponsor's protocol ID
- 2024-1751
- Other IDs
- 2023-026, non-PBA dated 7/8/24, 2023-1132
- Status last verified
- May 2026
- First submitted
- 14 Nov 2023
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Lung Ultrasound Scores to Determine Extubation Readiness in Neonates With Respiratory Distress on Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT06140615
- Acronym / sponsor ID
- 2024-1751
- Conditions
- Respiratory Distress of Newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Meriter Foundation
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 20 Nov 2023 (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 goal of this clinical trial is to determine whether lung ultrasound can predict extubation success in neonates with respiratory distress.
Participants will undergo a lung ultrasound pre- and post-extubation.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung ultrasound | Experimental | Device: UltrasoundParticipants undergo pre- and post-extubation lung ultrasound |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants born at UnityPoint Health Meriter Hospital and University of Minnesota admitted to the Neonatal Intensive Care Unit (NICU) with respiratory distress requiring intubation
- Meeting the extubation readiness criteria per the attending neonatologist
Key exclusion criteria (2 listed)
- Known major congenital disease (chromosomal abnormality, heart disease, respiratory malformation)
- Neonates with parents that are less than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundUltrasound of lungs | Device | Lung ultrasound |
Primary outcome
Ability of lung ultrasound score to predict extubation success
Time frame: 12 hours pre-extubation to 24 hours post extubation
Correlate the lung ultrasound score to the success of extubation, which is defined as remaining extubated for >72 hours. Ultrasound scores are measured on a 4-point scale (0=normal,3 = most abnormal).
5 secondary outcomes
Change in pre- and post-extubation lung ultrasound scores
Time frame: 12 hours pre-extubation to 24 hours post extubation
Time to re-intubation
Time frame: Up to 72 hours post-intubation
Change in heart rate
Time frame: 5 minutes before to 5 minutes after lung ultrasound
Change in respiratory rate
Time frame: 5 minutes before to 5 minutes after lung ultrasound
Change in oxygen saturation
Time frame: 5 minutes before to 5 minutes after lung ultrasound
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No
Related trials for Respiratory Distress of Newborn
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Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
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Measuring Diaphragm Electrical Activity in Neonates Using a Smaller Inter-electrode Distance
Respiratory Distress Syndrome, Newborn, Infant, Premature
Not yet recruitingObservational study
Chest Ultrasound as Diagnostic and Prognostic Tool in Neonatal RDS
Respiratory Distress Syndrome, Newborn, Neonatal Respiratory Distress
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Noninvasive High Frequency Oscillatory Ventilation Versus Nasal Intermittent Mandatory Ventilation for Respiratory Distress Syndrome in Preterm Neonates
Respiratory Distress Syndrome (RDS), Newborn
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Paternal Involvement in Nursing Guidance and Breastfeeding Self-Efficacy in Mothers of High-Risk Newborns
Prematurity, Low Birth Weight
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. This study is not recruiting at the moment.
Adam S Bauer, MD principal investigator
Meriter Foundation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Respiratory Distress of Newborn, run by University of Wisconsin, Madison at 2 sites 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability of lung ultrasound score to predict extubation success (time frame: 12 hours pre-extubation to 24 hours post extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2026; AzTrials last refreshed its copy on 29 Oct 2026.