PneumoniaLUS-POSforVAPNCT07254507
Lung Ultrasound-Guided Positioning Strategy for the Prevention of Ventilator-Associated Pneumonia in Neonates
A study testing standard positioning management and Lung Ultrasound Guided Localization in people with Pneumonia, run by Huiyi Li at 1 site in China.
Trial summary
This study aims to determine if using lung ultrasound to guide personalized positioning for ventilated newborns is more effective than standard repositioning at preventing ventilator-associated pneumonia. Read more about this study
- Who is it for?
- Ages 1 hour to 3 months
- Conditions the study is for
- Pneumonia
- What is being tested?
- standard positioning management and Lung Ultrasound Guided Localization
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Oct 2025
- 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 1 hour to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Eligible participants included term neonates (gestational age 37-42 weeks) who required invasive mechanical ventilation for more than 48 hours.
Who cannot join
- Exclusion criteria included ①preterm neonates; ② Neonates with early sepsis or previous pneumonia;③ Not suitable for patients with enteral nutrition;④ Newborns requiring mechanical ventilation due to surgery;⑤ There are many infants with congenital abnormalities or suspected chromosomal abnormalities.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second People's Hospital of Guangdong Province affiliated to Jinan University
Guangzhou, Guangdong, 510317
About this study
Official title: Evaluation of Lung Ultrasound-Guided Posture Management for Improving Outcomes in Neonatal Ventilator-Associated Pneumonia
This study aims to determine if using lung ultrasound to guide personalized positioning for ventilated newborns is more effective than standard repositioning at preventing ventilator-associated pneumonia.
Read the detailed description
This research study is testing a new strategy to help prevent Ventilator-Associated Pneumonia(VAP) in newborns who need a breathing machine (mechanical ventilator). VAP is a serious lung infection that can sometimes occur in the hospital.We are using abedside Lung Ultrasound (LUS). This is a safe, painless, and radiation-free imaging tool. It allows doctors to see how well different parts of a baby's lungs are inflated in real-time, much like a "window" into the lungs.Based on the lung ultrasound pictures,our healthcare team will create a personalized positioning plan for the baby (for example, placing them more on their side or on their tummy). The goal is to use gravity to help open up the lungs and drain any fluid, which may lower the risk of infection. We will compare this new method to the standard practice of turning babies every two hours.We believe this personalized,evidence-based care strategy could be more effective in preventing pneumonia. It may potentially help babies get off the breathing machine sooner and reduce their time in the neonatal intensive care unit (NICU).Lung ultrasound is a well-established and safe bedside procedure.This study has been carefully reviewed and approved by the hospital's Ethics Committee. All procedures will be performed by trained doctors and staff, with the baby's safety and comfort as our top priority.
- Conditions
- Pneumonia
- Being tested
- standard positioning management, Lung Ultrasound Guided Localization
- Keywords
- Pulmonary ultrasound, Body position management, Neonatal ventilator-associated pneumonia
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard positioning managementBehavioural
Infants in the control group had their positions adjusted every two hours, alternating between supine, left lateral, right lateral, and prone positions.The head of the bed should be elevated 15°-30° with the body in a slightly flexed position-hips aligned along the midline, shoulders slightly forward, head centered, and arms free to move. Position adjustments should only be made when vital signs are stable and resuscitation is delayed, or when adjusting the ventilator, administering IV fluids, or managing deep sleep. If heart rate fluctuates more than 20 beats per minute or SpO₂ drops below 90% (excluding airway obstruction), the interval between position adjustments should be extended to 3-4 hours. This group did not undergo ultrasound evaluation.
Lung Ultrasound Guided LocalizationBehavioural
In addition to routine care, two LUS assessments are conducted at fixed times daily (08:00 and 18:00) to guide individualized position adjustments by monitoring regional ventilation.①If unilateral atelectasis or pulmonary edema is detected, the patient should first be maintained in dependent lateral position for approximately 1 hour, then transition to the contralateral or prone position for 3 hours.②For lesions previously managed by the department, the prone position duration is reduced to 1 hour, while supine or lateral positions are extended to 3 hours. ③For posterior lesions, the supine or lateral position should be limited to 1 hour, while the prone position should be extended to 3 hours.④Resume the standard two-hour shift system once the symptoms or edema have subsided.If SpO₂ remains persistently below 90% (excluding operational or feeding disturbances), the respiratory rate increases by more than 20 breaths per minute from baseline, an additional LUS evaluation is required.
| Study group | Role | What they receive |
|---|---|---|
| Standard positioning management | Placebo comparator | NICU routine nursing Receives: Behavioral: standard positioning management |
| LUS-Guided Group (Lung Ultrasound-Guided Positioning) | Experimental | In addition to standard care, LUS assessments were conducted twice daily at fixed time points (08:00 and 18:00) to evaluate regional aeration and guide individualized postural adjustments. Receives: Behavioral: Lung Ultrasound Guided Localization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ventilator-associated pneumonia in neonates
Pneumonia that occurs 48 hours after mechanical ventilation (MV) and 48 hours after extubation is an important type of Hospital-acquired pneumonia (HAP), in which pneumonia that occurs within MV≤4 days is early-onset VAP, and pneumonia that occurs within MV ≥5 days is late-onset VAP.
Measured: From randomization until VAP diagnosis, successful extubation, or death, whichever occurs first, assessed up to 100 days.
Secondary outcomes (7)
feeding intolerance in newborns
Incidence of feeding intolerance at any level (mild+severe)
Measured: From the beginning of enteral feeding to the successful establishment of full enteral feeding, discharge or death. The evaluation will last until the end of the study, and the longest evaluation period for each participant is expected to be 100 days.
Pulmonary hemorrhage
Incidence of any grade of pulmonary hemorrhage
Measured: From the day of random grouping to the event, discharge or death, whichever comes first. The evaluation lasts for the whole invasive mechanical ventilation period and 24 hours after extubation, and the longest evaluation period is expected to be 100 days
Pneumothorax
Incidence of pneumothorax
Measured: From the day of random grouping to the event, discharge or death, whichever comes first. The evaluation lasts for the whole invasive mechanical ventilation period and 48 hours after extubation, and the longest evaluation period is expected to be 100 days
new intracranial hemorrhage
The incidence of any new intracranial hemorrhage (including symptomatic and asymptomatic)
Measured: From the day of random grouping to the end of discharge or study period, whichever comes first. Routine monitoring will last until the seventh day after birth, and the longest evaluation period is expected to be 120 days.
Mortality
Mortality during hospitalization
Measured: From the day of random grouping to the end of discharge or study period, whichever comes first. The longest evaluation period is expected to be 120 days.
Duration of invasive mechanical ventilation
Duration of ventilator use: from start to successful extubation or death.
Measured: Time is counted from invasive ventilation to successful extubation or death. The evaluation will last until the end of the study, and the longest evaluation period for each participant is expected to be 100 days.
NICU hospitalization duration
Time from admission to discharge for hospitalization
Measured: Time is counted from admission to transfer out of NICU or discharge. The evaluation will last until the end of the study, and the longest evaluation period for each participant is expected to be 120 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start1 Jan 2024
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huiyi Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Huiyi Li, Guangdong Second Provincial General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254507
- Sponsor's protocol ID
- 2023-KY-KZ-266-02
- Other IDs
- 2024A03J0771
- Acronym
- LUS-POSforVAP
- Status last verified
- Nov 2025
- First submitted
- 15 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study plans to share the collected individual participant data after de-identification.Specifically, it includes: demographic data (gestational age, birth weight, etc.), baseline characteristics, data related to VAP diagnostic criteria, lung ultrasound results, position adjustment records, mechanical ventilation duration, and all primary and secondary endpoint data (feeding intolerance, pulmonary hemorrhage, new intracranial hemorrhage, mortality rate, hospitalization days in NICU, etc.).
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lung Ultrasound-Guided Posture Management for Improving Outcomes in Neonatal Ventilator-Associated Pneumonia
- ClinicalTrials.gov ID
- NCT07254507
- Acronym / sponsor ID
- LUS-POSforVAP / 2023-KY-KZ-266-02
- Conditions
- Pneumonia
- Keywords
- Pulmonary ultrasound, Body position management, Neonatal ventilator-associated pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Huiyi LiUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 28 Nov 2025 (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 study aims to determine if using lung ultrasound to guide personalized positioning for ventilated newborns is more effective than standard repositioning at preventing ventilator-associated pneumonia.
Detailed description
This research study is testing a new strategy to help prevent Ventilator-Associated Pneumonia(VAP) in newborns who need a breathing machine (mechanical ventilator). VAP is a serious lung infection that can sometimes occur in the hospital.We are using abedside Lung Ultrasound (LUS). This is a safe, painless, and radiation-free imaging tool. It allows doctors to see how well different parts of a baby's lungs are inflated in real-time, much like a "window" into the lungs.Based on the lung ultrasound pictures,our healthcare team will create a personalized positioning plan for the baby (for example, placing them more on their side or on their tummy). The goal is to use gravity to help open up the lungs and drain any fluid, which may lower the risk of infection. We will compare this new method to the standard practice of turning babies every two hours.We believe this personalized,evidence-based care strategy could be more effective in preventing pneumonia. It may potentially help babies get off the breathing machine sooner and reduce their time in the neonatal intensive care unit (NICU).Lung ultrasound is a well-established and safe bedside procedure.This study has been carefully reviewed and approved by the hospital's Ethics Committee. All procedures will be performed by trained doctors and staff, with the baby's safety and comfort as our top priority.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard positioning management | Placebo comparator | Behavioral: standard positioning managementNICU routine nursing |
| LUS-Guided Group (Lung Ultrasound-Guided Positioning) | Experimental | Behavioral: Lung Ultrasound Guided LocalizationIn addition to standard care, LUS assessments were conducted twice daily at fixed time points (08:00 and 18:00) to evaluate regional aeration and guide individualized postural adjustments. |
Who may qualify
- Ages
- 1 hour to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Eligible participants included term neonates (gestational age 37-42 weeks) who required invasive mechanical ventilation for more than 48 hours.
Key exclusion criteria (1 listed)
- Exclusion criteria included ①preterm neonates; ② Neonates with early sepsis or previous pneumonia;③ Not suitable for patients with enteral nutrition;④ Newborns requiring mechanical ventilation due to surgery;⑤ There are many infants with congenital abnormalities or suspected chromosomal abnormalities.
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 |
|---|---|---|
| standard positioning managementInfants in the control group had their positions adjusted every two hours, alternating between supine, left lateral, right lateral, and prone positions.The head of the bed should be elevated 15°-30° with the body in a slightly flexed position-hips aligned along the midline, shoulders slightly forward, head centered, and arms free to move. Position adjustments should only be made when vital signs are stable and resuscitation is delayed, or when adjusting the ventilator, administering IV fluids, or managing deep sleep. If heart rate fluctuates more than 20 beats per minute or SpO₂ drops below 90% (excluding airway obstruction), the interval between position adjustments should be extended to 3-4 hours. This group did not undergo ultrasound evaluation. | Behavioural | Standard positioning management |
| Lung Ultrasound Guided LocalizationIn addition to routine care, two LUS assessments are conducted at fixed times daily (08:00 and 18:00) to guide individualized position adjustments by monitoring regional ventilation.①If unilateral atelectasis or pulmonary edema is detected, the patient should first be maintained in dependent lateral position for approximately 1 hour, then transition to the contralateral or prone position for 3 hours.②For lesions previously managed by the department, the prone position duration is reduced to 1 hour, while supine or lateral positions are extended to 3 hours. ③For posterior lesions, the supine or lateral position should be limited to 1 hour, while the prone position should be extended to 3 hours.④Resume the standard two-hour shift system once the symptoms or edema have subsided.If SpO₂ remains persistently below 90% (excluding operational or feeding disturbances), the respiratory rate increases by more than 20 breaths per minute from baseline, an additional LUS evaluation is required. | Behavioural | LUS-Guided Group (Lung Ultrasound-Guided Positioning) |
Primary outcome
Incidence of ventilator-associated pneumonia in neonates
Time frame: From randomization until VAP diagnosis, successful extubation, or death, whichever occurs first, assessed up to 100 days.
Pneumonia that occurs 48 hours after mechanical ventilation (MV) and 48 hours after extubation is an important type of Hospital-acquired pneumonia (HAP), in which pneumonia that occurs within MV≤4 days is early-onset VAP, and pneumonia that occurs within MV ≥5 days is late-onset VAP.
7 secondary outcomes
feeding intolerance in newborns
Time frame: From the beginning of enteral feeding to the successful establishment of full enteral feeding, discharge or death. The evaluation will last until the end of the study, and the longest evaluation period for each participant is expected to be 100 days.
Pulmonary hemorrhage
Time frame: From the day of random grouping to the event, discharge or death, whichever comes first. The evaluation lasts for the whole invasive mechanical ventilation period and 24 hours after extubation, and the longest evaluation period is expected to be 100 days
Pneumothorax
Time frame: From the day of random grouping to the event, discharge or death, whichever comes first. The evaluation lasts for the whole invasive mechanical ventilation period and 48 hours after extubation, and the longest evaluation period is expected to be 100 days
new intracranial hemorrhage
Time frame: From the day of random grouping to the end of discharge or study period, whichever comes first. Routine monitoring will last until the seventh day after birth, and the longest evaluation period is expected to be 120 days.
Mortality
Time frame: From the day of random grouping to the end of discharge or study period, whichever comes first. The longest evaluation period is expected to be 120 days.
Duration of invasive mechanical ventilation
Time frame: Time is counted from invasive ventilation to successful extubation or death. The evaluation will last until the end of the study, and the longest evaluation period for each participant is expected to be 100 days.
NICU hospitalization duration
Time frame: Time is counted from admission to transfer out of NICU or discharge. The evaluation will last until the end of the study, and the longest evaluation period for each participant is expected to be 120 days.
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 28 Nov 2025.
- Individual participant dataSharing planned: Yes. This study plans to share the collected individual participant data after de-identification.Specifically, it includes: demographic data (gestational age, birth weight, etc.), baseline characteristics, data related to VAP diagnostic criteria, lung ultrasound results, position adjustment records, mechanical ventilation duration, and all primary and secondary endpoint data (feeding intolerance, pulmonary hemorrhage, new intracranial hemorrhage, mortality rate, hospitalization days in NICU, etc.).
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard positioning management and Lung Ultrasound Guided Localization in people with Pneumonia, run by Huiyi Li at 1 site in China.
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 1 inclusion and 1 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 28 Nov 2025. 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 China. 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. Some participants in this study may receive a placebo. 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?
Incidence of ventilator-associated pneumonia in neonates (time frame: From randomization until VAP diagnosis, successful extubation, or death, whichever occurs first, assessed up to 100 days.). 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 28 Nov 2025.