Neonatal Respiratory FailureNeoLUS-RCTNCT07386041
Lung Ultrasound-Guided Respiratory Management in Infants
A study testing Lung ultrasound-guided respiratory management in people with Neonatal Respiratory Failure, run by Tufts Medical Center.
Trial summary
This single-center randomized controlled study will compare lung ultrasound-guided respiratory management with standard clinical care in infants requiring respiratory support. The primary outcome measure is length of NICU stay. Read more about this study
- Who is it for?
- Ages 0 years to 1 yearHealthy volunteers can take part
- Conditions the study is for
- Neonatal Respiratory Failure
- What is being tested?
- Lung ultrasound-guided respiratory management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Feb 2029
- Phase
- Interventional
- 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 0 years to 1 year
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants admitted to the Tufts Medical Center NICU
- Requiring invasive or non-invasive respiratory support
- Requiring surfactant therapy
- Parental or guardian informed consent obtained
Who cannot join
- Major congenital anomalies
- Known chromosomal abnormalities
- Congenital diaphragmatic hernia
- Decision for comfort care
- Surfactant administered prior to transfer from outside hospital (only excluded for surfactant decisions)
About this study
Official title: Lung Ultrasound-Guided Respiratory Management in Infants: A Single-Center Randomized Controlled Trial
This single-center randomized controlled study will compare lung ultrasound-guided respiratory management with standard clinical care in infants requiring respiratory support.
The primary outcome measure is length of NICU stay.
Read the detailed description
Infants, especially premature infants, frequently require respiratory support in the neonatal intensive care unit (NICU). Lung ultrasound is a bedside, radiation-free tool that can assess lung aeration and guide respiratory management, but its effect on clinical outcomes has not been evaluated in a U.S. randomized trial.
This single-center randomized controlled study will compare lung ultrasound-guided respiratory management with standard clinical care in premature infants requiring respiratory support. In the intervention group, lung ultrasound scores will guide surfactant administration, weaning non-invasive respiratory support, and weaning from non-invasive respiratory support to room air using predefined thresholds. The control group will use standard care to guide surfactant administration, weaning non-invasive respiratory support, and weaning from non-invasive respiratory support to room air.
The primary outcome is length of NICU stay. Secondary outcomes include duration of respiratory support, time on non-invasive respiratory support, time to successful weaning to room air, need for re-intubation, surfactant dosing, and mortality prior to discharge. This study aims to determine whether lung ultrasound-guided management can improve respiratory care and reducive hospital length of stay in infants requiring respiratory suppport.
- Conditions
- Neonatal Respiratory Failure
- Being tested
- Lung ultrasound-guided respiratory management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasound-guided respiratory managementProcedure or surgery
Scheduled lung ultrasounds are performed to guide decisions about surfactant administration, non-invasive respiratory support weaning, and transition to room air using predefined lung ultrasound score thresholds.
| Study group | Role | What they receive |
|---|---|---|
| Intervention - Lung ultrasound guided respiratory management | Experimental | Participants randomized to this group will under lung ultrasound assessments at predefined clinical time points. Lung ultrasound scores will guide:
* Surfactant administration in the early neonatal period
* Weaning from non-invasive respiratory suppport
* Transition to room air
Decisions will follow predefined lung ultrasound score thresholds using a validating scoring system. Ultrasounds to be performed by trained neonatal providers using standardized techniques. Attending neonatologists may override protocol recommendations if clinically necessary, with documentation Receives: Procedure: Lung ultrasound-guided respiratory management |
| Control - Standard Clinical Care | No intervention | Participants randomized to this group will receive respiratory management based on standard NICU clinical criteria including oxygen requirement, work of breathing, blood gas measurements, and radiographic findings. Lung ultrasound may be performed if clinically indicated, but will not be used for protocolized decision making. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of NICU stay (days)
Measured: From date of NICU admission to date of hospital discharge up to one year
Secondary outcomes (7)
Duration of any respiratory support
Measured: From date of initiation of respiratory support to date of discontinuation of respiratory support, up to one year
Duration of non-invasive respiratory support
Measured: From date of initiation of non-invasive respiratory support to date of discontinuation of non-invasive respiratory support up to one year.
Time to successful weaning to room air
Measured: From date of initiation of respiratory support to date of sustained room air without support for at least 48h, up to one year.
Weaning failure
Measured: From date of weaning respiratory support, to date of re-escalation of respiratory support if needed, up to 72 hours
Need for reintubation
Measured: From date of extubation, to date of reintubation, up to 72 hours.
Number of surfactant doses administered
Measured: Number of surfactant doses quantified over the course through study completion, up to an average of 1 year.
Mortality prior to discharge
Measured: From date of birth until the date of death from any cause, assessed up to one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neonatal Respiratory FailureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized in a 1:1 ratio to either the lung ultrasound-guided respiratory management group or the standard care group. Both groups are followed concurrently to compare outcomes.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386041
- Sponsor's protocol ID
- STUDY00006737
- Acronym
- NeoLUS-RCT
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brat R, Yousef N, Klifa R, Reynaud S, Shankar Aguilera S, De Luca D. Lung Ultrasonography Score to Evaluate Oxygenation and Surfactant Need in Neonates Treated With Continuous Positive Airway Pressure. JAMA Pediatr. 2015 Aug;169(8):e151797. doi: 10.1001/jamapediatrics.2015.1797. Epub 2015 Aug 3.
PubMed 26237465Gathright M, Chacko A, Paulson M, O'Connor B, Mansky R, Lasarev M, Cowan E, Hulse W, Monroe E, Alfaro E, Baker M, Bauer AS, Diego E. An Evaluation of Vital Signs in Intubated Neonates Undergoing Lung Point-of-Care Ultrasound in the Neonatal Intensive Care Unit. J Clin Ultrasound. 2026 Jun;54(5):1072-1078. doi: 10.1002/jcu.70161. Epub 2025 Dec 22.
PubMed 41427513
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Ultrasound-Guided Respiratory Management in Infants: A Single-Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07386041
- Acronym / sponsor ID
- NeoLUS-RCT / STUDY00006737
- Conditions
- Neonatal Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 4 Feb 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.
This single-center randomized controlled study will compare lung ultrasound-guided respiratory management with standard clinical care in infants requiring respiratory support.
The primary outcome measure is length of NICU stay.
Detailed description
Infants, especially premature infants, frequently require respiratory support in the neonatal intensive care unit (NICU). Lung ultrasound is a bedside, radiation-free tool that can assess lung aeration and guide respiratory management, but its effect on clinical outcomes has not been evaluated in a U.S. randomized trial.
This single-center randomized controlled study will compare lung ultrasound-guided respiratory management with standard clinical care in premature infants requiring respiratory support. In the intervention group, lung ultrasound scores will guide surfactant administration, weaning non-invasive respiratory support, and weaning from non-invasive respiratory support to room air using predefined thresholds. The control group will use standard care to guide surfactant administration, weaning non-invasive respiratory support, and weaning from non-invasive respiratory support to room air.
The primary outcome is length of NICU stay. Secondary outcomes include duration of respiratory support, time on non-invasive respiratory support, time to successful weaning to room air, need for re-intubation, surfactant dosing, and mortality prior to discharge. This study aims to determine whether lung ultrasound-guided management can improve respiratory care and reducive hospital length of stay in infants requiring respiratory suppport.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized in a 1:1 ratio to either the lung ultrasound-guided respiratory management group or the standard care group. Both groups are followed concurrently to compare outcomes.
| Arm | Type | Receives |
|---|---|---|
| Intervention - Lung ultrasound guided respiratory management | Experimental | Procedure: Lung ultrasound-guided respiratory managementParticipants randomized to this group will under lung ultrasound assessments at predefined clinical time points. Lung ultrasound scores will guide: * Surfactant administration in the early neonatal period * Weaning from non-invasive respiratory suppport * Transition to room air Decisions will follow predefined lung ultrasound score thresholds using a validating scoring system. Ultrasounds to be performed by trained neonatal providers using standardized techniques. Attending neonatologists may override protocol recommendations if clinically necessary, with documentation |
| Control - Standard Clinical Care | No intervention | –Participants randomized to this group will receive respiratory management based on standard NICU clinical criteria including oxygen requirement, work of breathing, blood gas measurements, and radiographic findings. Lung ultrasound may be performed if clinically indicated, but will not be used for protocolized decision making. |
Who may qualify
- Ages
- 0 years to 1 year
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants admitted to the Tufts Medical Center NICU
- Requiring invasive or non-invasive respiratory support
- Requiring surfactant therapy
- Parental or guardian informed consent obtained
Key exclusion criteria (5 listed)
- Major congenital anomalies
- Known chromosomal abnormalities
- Congenital diaphragmatic hernia
- Decision for comfort care
- Surfactant administered prior to transfer from outside hospital (only excluded for surfactant decisions)
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 |
|---|---|---|
| Lung ultrasound-guided respiratory managementScheduled lung ultrasounds are performed to guide decisions about surfactant administration, non-invasive respiratory support weaning, and transition to room air using predefined lung ultrasound score thresholds. | Procedure or surgery | Intervention - Lung ultrasound guided respiratory management |
Primary outcome
Length of NICU stay (days)
Time frame: From date of NICU admission to date of hospital discharge up to one year
7 secondary outcomes
Duration of any respiratory support
Time frame: From date of initiation of respiratory support to date of discontinuation of respiratory support, up to one year
Duration of non-invasive respiratory support
Time frame: From date of initiation of non-invasive respiratory support to date of discontinuation of non-invasive respiratory support up to one year.
Time to successful weaning to room air
Time frame: From date of initiation of respiratory support to date of sustained room air without support for at least 48h, up to one year.
Weaning failure
Time frame: From date of weaning respiratory support, to date of re-escalation of respiratory support if needed, up to 72 hours
Need for reintubation
Time frame: From date of extubation, to date of reintubation, up to 72 hours.
Number of surfactant doses administered
Time frame: Number of surfactant doses quantified over the course through study completion, up to an average of 1 year.
Mortality prior to discharge
Time frame: From date of birth until the date of death from any cause, assessed up to one year.
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 4 Feb 2026.
- Background: PubMed 26237465Brat R, Yousef N, Klifa R, Reynaud S, Shankar Aguilera S, De Luca D. Lung Ultrasonography Score to Evaluate Oxygenation and Surfactant Need in Neonates Treated With Continuous Positive Airway Pressure. JAMA Pediatr. 2015 Aug;169(8):e151797. doi: 10.1001/jamapediatrics.2015.1797. Epub 2015 Aug 3.
- Background: PubMed 41427513Gathright M, Chacko A, Paulson M, O'Connor B, Mansky R, Lasarev M, Cowan E, Hulse W, Monroe E, Alfaro E, Baker M, Bauer AS, Diego E. An Evaluation of Vital Signs in Intubated Neonates Undergoing Lung Point-of-Care Ultrasound in the Neonatal Intensive Care Unit. J Clin Ultrasound. 2026 Jun;54(5):1072-1078. doi: 10.1002/jcu.70161. Epub 2025 Dec 22.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Lung ultrasound-guided respiratory management in people with Neonatal Respiratory Failure, run by Tufts Medical Center.
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 4 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: opening soon, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Length of NICU stay (days) (time frame: From date of NICU admission to date of hospital discharge up to one year). 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 NCT07386041, which also lists 2 linked publications.
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 4 Feb 2026.