Evaluation of Lung Ultrasound-Guided Posture Management for Improving Outcomes in Neonatal Ventilator-Associated Pneumonia
Phase: NA
Conditions: Pneumonia
Sponsor: Huiyi Li

A lung ultrasound-guided strategy for
preventing ventilator-associated
pneumonia in newborns
Clinical Study Protocol
Lead unit: Guangdong Second PeoplesHospital
Project leader:Li Huiyi
Department: Pediatrics
Contactnumber: 15920384868
Participatingunits:None
Researchperiod:November1,2023toDecember31,2025.
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Versiondate:October 1,2023

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scenario summary
project name
A lung ultrasound-guided strategy for preventing ventilator-
associated pneumonia in newborns
purpose of
research
This prospective randomized controlled trial, conducted from
December 2023 to December 2025, enrolled full-term newborns
requiring continuous mechanical ventilation for over 48 hours. The
study evaluated whether a lung ultrasound-guided position adjustment
strategy could reduce the risk ofventilator-associated pneumonia (VAP)
in these infants compared to the traditional
empirical position
adjustment protocol.
research
design
Eligible infants were randomly assigned in a 1:1 ratio to receive
either conventional positioning management or LUS-guided
positioning management. The LUS-guided group underwent bedside
ultrasound assessments twice daily to monitor for atelectasis or
consolidation, with positional adjustments made based on findings to
optimize dependent drainage and ventilation-perfusion coupling.
Primary endpoints included VAP incidence, while secondary
endpoints comprised mechanical ventilation duration, feeding
intolerance, pulmonary hemorrhage, pneumothorax, new intracranial
hemorrhage, mortality, and ICU length of stay.
Total study
cases
94 cases (4 7 cases per group)
Case Selection
Inclusion criteria: Full-term newborns (gestational age 37-42 weeks)
requiring continuous mechanical ventilation for over 48 hours. The
diagnosis ofVAP follows the guidelines established by the U.S. Centers
for Disease Control and Prevention (CDC) (18), applicable to infants
under one year old receiving mechanical ventilation for more than 48
hours. Diagnosis requires: chest imaging demonstrating new or
progressively worsening pulmonary infiltrates, accompanied by
deterioration in gas exchange function.

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Additionally, at least three ofthe following clinical or laboratory
findings must be present: abnormal body temperature (rectal
temperature>38°C or <35.5°C), leukopenia (WBC <4×109 /L) or
leukocytosis (WBC>15×109 /L) with left shift (>10% band cells),
purulent or increased tracheal secretions, altered sputum characteristics,
increased secretions requiring frequent suction, apnea, signs ofrespiratory
distress (tachypnea, chest retractions, wheezing, nasal flaring), abnormal
breath sounds , bradycardia (<100 bpm) or tachycardia (>170 bpm).

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Exclusion criteria: ①Premature infants; ②Neonates with early-
onset sepsis or prior pneumonia; ③Patients unsuitable for enteral
nutrition; ④Neonates requiring mechanical ventilation for surgical
procedures; ⑤Infants with multiple congenital anomalies or suspected
chromosomal abnormalities. Any ofthese criteria must be met for
exclusion from the study.
therapeutic
regimen
All infants underwent invasive ventilation via endotracheal
intubation using the SLE6000 mechanical ventilator with a heated
humidification system, employing disposable respiratory circuits.
Both groups received standard NICU care including standardized
VAP prophylaxis, antibiotic therapy when indicated, and routine
nursing management in accordance with hospital policies and
international guidelines. Antibiotic selection and adjustment followed
local antimicrobial stewardship guidelines, with modifications based
on culture and susceptibility results. The control group received
conventional positioning management, while the LUS-guided group
utilized lung ultrasound-guided positioning management.

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Efficacy
Evaluation
Effectiveness evaluation indicators (main efficacy indicators and
secondary efficacy indicators)
Main therapeutic index: the effect oflung ultrasound-guided
positioning management on the incidence ofventilator-associated
pneumonia in newborns with mechanical ventilation.
Secondary efficacy endpoints included feeding intolerance in
newborns, pulmonary hemorrhage, pneumothorax, new-onset
intracranial hemorrhage, mortality, duration of invasive mechanical
ventilation (from initiation to successful extubation or death), and
NICU length of stay.
Safety evaluation indicators: mortality and complication incidence

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Statistical
Methods
Statistical analysis was performed using IBM SPSS Statistics
(version 20.0; IBM Corporation, Amherst, New York, USA). Continuous
variables were presented as mean ± standard deviation (SD) or median
(interquartile range, IQR) based on their distribution patterns, while
categorical data were expressed as frequencies and percentages.
Categorical variables were compared using chi-square test or Fishers
exact test, whereas continuous variables were analyzed using independent
samples t-test or Mann-Whitney U test as appropriate. A two-tailed P-
value <0.05 was considered statistically significant. This analysis strictly
followed the original research protocol, with all procedures conducted as
planned.
Study
duration
FromNovember1,2023toDecember31,2025

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I. Research Background
Ventilator-associated pneumonia (VAP) ranks among the most prevalent and
severe nosocomial infections in neonatal intensive care units (NICU), leading to
prolonged mechanical ventilation, extended hospital stays, and increased mortality. The
incidence ofneonatal VAP (Neo-VAP) varies significantly across different monitoring
criteria and patient populations: in high-income countries, it ranges from 1.4 to 7 cases
per 1,000 ventilator days, while in developing countries, the figure can reach up to 89
cases per 1,000 ventilator days.［1,2］。
Premature infants and extremely low birth weight infants are exposed to invasive
ventilation due to immature immune defense, impaired mucosal ciliary clearance
function, and prolonged exposure to invasive ventilation［3,4］, which is high risk.
The pathogenesis of novel VAP involves three key mechanisms: microaspiration
of contaminated secretions, colonization ofbiofilm on tracheal intubation, and gravity-
dependent accumulation of airway secretions.［5］Inappropriate or static postures may
exacerbate lung collapse and secretions retention, leading to ventilation-perfusion
mismatch, hypoxemia, and bacterial overgrowth. Studies in adult and pediatric patients
demonstrate that appropriate positioning interventions—such as semi-recumbent or
prone positions—can improve oxygenation and potentially reduce VAP incidence.［6,7］
However, these strategies have not been sufficiently standardized or validated in
newborns, as their immature thermoregulation and unstable hemodynamics limit
frequent positional adjustments.［8-10］。
Lung ultrasound (LUS) has emerged as a reliable, radiation-free bedside imaging
tool for dynamic assessment ofpulmonary ventilation, atelectasis, and consolidation in
newborns.［11-13］The quantitative LUS score provides real-time assessment of regional
ventilation, enabling early detection of asymmetric ventilation patterns.［14,15］By
incorporating LUS findings into positional management, we can develop
physiologically based strategies to optimize lung re-expansion and secretions clearance
before irreversible infection occurs.

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However, clinical evidence supporting this approach in newborns remains limited.
To address this, our study evaluated the clinical effectiveness of lung ultrasound-guided
targeted interventions in preventing mechanical ventilation-associated pneumonia (Neo
-VAP). We hypothesized that LUS-guided personalized interventions would reduce
VAP incidence and improve respiratory function compared to conventional care-guided
positioning.
II. Research Objectives
1. The primary objective was to evaluate whether a lung ultrasound-guided
positioning strategy could reduce the risk ofventilator-associated pneumonia
(VAP) in mechanically ventilated newborns compared to traditional empirical
positioning protocols.
2. Secondary objective: To enhance the effectiveness ofVAP prevention in newborns
and expand the clinical applications ofultrasound technology.
III. Types ofresearch design, principles and experimental steps
1. research design
Thisprospectiverandomized controlledtrialwas conducted fromDecember2023to
December2025 atthe Tertiary ICU ofGuangdong SecondPeoplesHospital, enrolling full-
termnewbornsrequiring continuousmechanicalventilation forover48hours.Eligible
infantswererandomly assignedin a 1:1ratiotoreceive either conventionalposition
management orLUS-guidedpositionmanagement. TheLUS-guidedgroupunderwent
bedsideultrasound assessmentstwice dailytomonitor atelectasis orconsolidation,with
position adjustmentsmadebased on evaluationresultsto optimizedependent drainageand
ventilation-perfusionmatching.Primary outcomewasVAP incidence,while secondary
outcomesincludedmechanicalventilation duration, feeding intolerance,pulmonary
hemorrhage,pneumothorax,new intracranialhemorrhage,mortality, and ICU length of
stay.
2.stages ofresearch

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IV. Case Selection
This prospective randomized controlled trial was conducted from December
2023 to December 2025 at the tertiary ICU of Guangdong Second Peoples Hospital,
enrolling full-term newborns requiring continuous mechanical ventilation for over 48
hours.
1. Selection criteria

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All enrolled newborns underwent prospective observation to monitor the
incidence of ventilator-associated pneumonia (VAP). VAP diagnosis was based on
the criteria established by the U.S. Centers for Disease Control and Prevention (CDC).
［16］This is indicated for infants under one year of age receiving mechanical
ventilation for more than 48 hours. Diagnosis requires: chest imaging demonstrating
new or progressive pulmonary infiltrates with deterioration of gas exchange function.
Additionally, at least three ofthe following clinical or laboratory findings must
be present: abnormal body temperature (rectal temperature>38°C or <35.5°C),
leukopenia (WBC <4×10⁹ /L) or leukocytosis (WBC>15×10⁹ /L) with left shift
(>10% band cells), purulent or increased tracheal secretions, altered sputum
characteristics, increased secretions requiring frequent suction, apnea, signs of
respiratory distress (tachypnea, chest retractions, wheezing, nasal flaring), abnormal
breath sounds (rheumus, crackles, or snoring), bradycardia (<100 bpm) or tachycardia
(>170 bpm).
2. Exclusion criteria
①premature ；
②Neonates with early sepsis or previous pneumonia;
③Not suitable for patients with enteral nutrition;
④Newborns requiring mechanical ventilation due to surgery;
⑤There are many infants with congenital abnormalities or suspected chromosomal
abnormalities.
Those who meet any ofthe above criteria will be excluded and excluded from this study.
3. Filter criteria
Participants enrolled in the group who meet one of the following criteria should be
excluded:
(1) Those who do not meet the inclusion criteria or meet the exclusion criteria after
inclusion.
(2)No record.
(3) Individuals who have not used the trial drug or intervention.
The analysis set is determined by a blind review meeting to exclude cases. The
reasons for exclusion should be documented, and the original data should be
retained for reference.
4.Drop/Exit criteria
Drop/Exit criteria:
(1) The chiefphysician considers that the clinical condition is not suitable for further
experimentation;
(2) If there is a discrepancy between clinical symptoms and other auxiliary examinations
and the results ofrelevant non-invasive examinations;
(3) Parents who do not agree to continue the experiment during the experiment
5. Termination criteria

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(1) Ifthe following complications occur during the experiment: cardiac arrest,
intestinal perforation, intracranial complications, etc.;

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(2) Those who need to be rescued and are not suitable for experimental operations;
(3) The chiefphysician considers that the clinical condition is not suitable for further
experimentation;
(4) If there is a discrepancy between clinical symptoms and other auxiliary examinations
and the results ofrelevant non-invasive examinations;
(5) Parents who refuse to continue the experiment during the experiment
V. Research Methods and Technical Routes
This prospective randomized controlled trial was conducted from December
2023 to December 2025 at the Tertiary ICU of Guangdong Second Peoples Hospital,
enrolling full-term newborns requiring continuous mechanical ventilation for over 48
hours. Eligible infants were randomly assigned in a 1:1 ratio to receive either
conventional position management or LUS-guided position management. The LUS-
guided group underwent bedside ultrasound assessments twice daily to monitor
atelectasis or consolidation, with position adjustments made based on evaluation
results to optimize dependent drainage and ventilation-perfusion matching. Primary
outcome was VAP incidence, while secondary outcomes included mechanical
ventilation duration, feeding intolerance, pulmonary hemorrhage, pneumothorax, new
intracranial hemorrhage, mortality, and ICU length of stay.
VI. Observation items and testing time points
All infants underwent invasive ventilation using the SLE6000 mechanical
ventilator with a heated humidifier via endotracheal intubation, employing disposable
respiratory circuits. Both groups received standard NICU care, including standardized
VAP prophylaxis,
antibiotic therapy
when
indicated, and
routine
nursing
management in accordance with hospital protocols and international guidelines.
Antibiotic selection and adjustment followed local antimicrobial stewardship
guidelines, with modifications based on culture and susceptibility test results.On the
1st, 3rd and 7th day of mechanical ventilation, chest radiographs were taken in the
positive and lateral positions respectively, and repeated examinations were made
according to clinical needs.
Control group (standard positioning management)
Infants in the control group had their positions adjusted every two hours,
alternating between supine, left lateral, right lateral, and prone positions.［17］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
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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.
LUS Guided Group (Lung Ultrasound Guided Localization)
Postural adjustments follow three principles: ensuring effective drainage of the
affected lung area, optimizing ventilation of the healthy area, and preventing stress-
related injury［16,18］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.
• Ifunilateral 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.
• For 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.
• For posterior lesions, the supine or lateral position should be limited to 1 hour,
while the prone position should be extended to 3 hours.
• Resume 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, or airway secretions significantly increase, an additional LUS evaluation is
required.
All ultrasound examinations
are performed by
two pediatricians
with
professional training, while the imaging data undergoes quality review by senior
neonatologists with pulmonary ultrasound experience. All physicians receive semi-
annual intensive care ultrasound hands-on training from internationally certified
instructors to ensure consistent diagnostic standards and standardized technical
procedures.
VII. Criteria for efficacy evaluation
Main efficacy criteria: the effect of lung ultrasound-guided positioning management on
the incidence ofventilator-associated pneumonia in mechanical ventilation newborns.

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Secondary efficacy criteria included feeding intolerance in newborns, pulmonary
hemorrhage, pneumothorax, new intracranial hemorrhage, mortality, duration of
invasive mechanical ventilation (from initiation to successful extubation or death),
and NICU hospitalization duration.
VIII. OBSERVATION OF ADVERSE EVENTS
Adverse event monitoring: During the trial, clinicians should continuously monitor
the childs vital signs. If clinical symptoms or auxiliary findings (e.g., heart rate,
liver size, mental status, X-ray, blood gas analysis) contradict non-invasive test
results, the trial should be immediately terminated and the attending physician
should be promptly consulted.
IX. Data security monitoring
Clinical trials will establish data safety monitoring plans based on risk levels.
All adverse events will be meticulously documented, properly managed, and tracked
until resolved or stabilized. Serious adverse events and unexpected incidents must be
promptly reported to ethics committees, regulatory authorities, sponsors, and drug
regulatory agencies as required. Principal investigators will conduct periodic
cumulative reviews of all adverse events, and when necessary, convene investigator
meetings to evaluate the risks and benefits of the trial. For double-blind trials,
emergency unblinding may be conducted when required to ensure participant safety
and rights. Studies exceeding the minimum risk threshold will have independent data
monitors assigned to oversee data collection. High-risk studies will establish
independent data safety monitoring committees to review cumulative safety and
efficacy data, providing recommendations on whether to continue the trial.
X. Statistical processing
Statistical analysis was performed using IBM SPSS Statistics (version 20.0; IBM,
Inc., Amherst, New York, USA). Continuous variables were presented as mean ±
standard deviation (SD) or median (interquartile range, IQR) based on their distribution
patterns, while categorical data were expressed as frequencies and percentages.
Categorical variables were compared using chi-square test or Fishers exact test, whereas
continuous variables were analyzed using independent samples t-test or Mann-Whitney
U test as appropriate. A two-tailed P-value <0.05 was considered statistically significant.
All procedures were conducted strictly in accordance with the original research protocol.
XI. ETHEICAL ASPECTS OF CLINICAL RESEARCH

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XIII. Participants
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Clinical research will adhere to the World Medical Conferences Helsinki
Declaration and related regulations. The study will only commence after obtaining
approval from the ethics committee for the trial protocol. Before enrolling any
participant, researchers must provide a complete and comprehensive explanation of
the studys objectives, procedures, and potential risks to the participant or their
representative, who must sign a written informed consent form. Participants should
be informed of their right to withdraw from the study at any time, and the informed
consent document must be retained as part ofthe clinical research records for review.
Throughout the study, participants personal privacy and data confidentiality will be
strictly protected.
XII. STUDY PROGRESS
time
research contents
April 2024-December2024
Trial preparation phase
①Prepare relevant instruments and equipment, as well as
equipment maintenance, testing, and parameter calibration;
②Staffrecruitment and training, clear division oflabor and
work content, familiar with the test process;
③Complete the pre-experiment.
January2025-December2025
Recruit subjects and conduct clinical trials
①Recruit research subjects and implement interventions
according to the randomized protocol;
②Record test data.
January2026-March 2026
Write scientific research papers and project summary reports
①Organize and analyze research data;
②Scientific research paper writing and submission;
③Summarize research results and write project summary report.
surname
and
personal
name
Title/Field of Study
divide the work
Ethics
course
name
and time
training

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Li Huiyi
Associate Head
Nurse/Nursing
project leader
2021-07-09
Hudaiju
Intermediate/Nursing
conceptual design
Liang
Zhenyu
Senior Associate
Pediatrician
conceptual design
2021-07-10
Huang
Xihua
Associate Head
Nurse/Nursing
Specific experiments
and data collection
2021-07-09
Meng
Qiong
Senior
Physician/Pediatrics
DA
2021-07-09
Yang
Qiaohuan
Senior Associate
Pediatrician
Data analysis and
quality control
2021-07-13
Chen Na
Intermediate/Pediatric
Specific experiments
and data collection
2021-07-13
Li Lin
Primary/Pediatric
Specific experiments
and data collection
XIV. References
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［2］Rosenthal VD et al. International Nosocomial Infection Control Consortium (INICC)
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［3］Thatrimontrichai A et al. Ventilator-associated pneumonia in neonates: a prospective
observational study. J Perinatol. 2017;37(6):669-674. doi:10.1038/jp.2017.11
［4］Dang J et al. Risk factors and outcomes ofventilator-associated pneumonia in a
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doi:10.1186/s12879-023-08073-x
［5］Howroyd C et al. Ventilator-associatedpneumonia: pathobiological heterogeneity
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［6］Oczkowski S et al. Body position forpreventing ventilator-associated pneumonia in
adults: systematic review and network meta-analysis. Cochrane Database Syst Rev.
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［7］7.Pawlik AJ et al. Ventilator-associated pneumonia prevention in pediatric patients:
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［8］Rivas-Fernandez M et al. Infant position in neonates receiving mechanical
ventilation. Cochrane Database Syst Rev. 2016;11:CD003668. PMID: 27819747
［9］Hough JL et al. Effect oftime and body position on ventilation in premature infants.
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ventilated neonates: a prospective observational study. EClinicalMedicine. 2023;58:101904.
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［1 2］Ruoss JL et al. Lung ultrasound in the neonatal intensive care unit. Children
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［1 3］YousefN et al. Lung ultrasound monitoring in neonatal and pediatric intensive
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［1 5］Szymański P et al. Modified lung ultrasound score predicts ventilation
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［1 6］Klompas M, Branson R, Eichenwald EC, et al. Strategies to prevent ventilator-
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［1 8］Centers for Disease Control and Prevention (CDC). *NHSN Ventilator-Associated
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