Severe neonatal pneumonia
Conditions
Interventions
Intervention group:Nurse-led POCUS-guided targeted chest physiotherapy in addition to standard care. Trained and certified nurses perform lung POCUS every 8 hours and provide targeted gentle chest per
Control group:Standard care, including routine respiratory support, antimicrobial treatment, mechanical ventilation management, and usual NICU care. No routine POCUS-guided targeted chest physiotherap
conventional chest physiotherapy may be used at the discretion of the clinical team.
Sponsors
Fujian Children’s Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Term neonates (gestational age >=37+0 weeks at birth). 2. Diagnosis of severe pneumonia requiring invasive mechanical ventilation for respiratory failure. In this study, severe pneumonia is defined as clinically diagnosed pneumonia, based on signs of acute respiratory infection together with radiographic or ultrasonographic evidence of consolidation or infiltrate, that results in respiratory failure requiring intubation and invasive mechanical ventilation. Both early-onset and community-acquired neonatal pneumonia will be included. 3. Imaging-confirmed lung consolidation in at least one lobe or region. Confirmation may be obtained by chest radiography or lung ultrasound performed at or near the time of enrolment, demonstrating pulmonary consolidation, defined as a subpleural region with tissue-like or liver-like echotexture on ultrasound or as a lobar opacity on chest radiography, with or without air bronchograms. 4. Infants must be enrolled within 48 hours of starting mechanical ventilation for pneumonia.
Exclusion criteria
Exclusion criteria: 1. Preterm infants (gestational age <37 weeks at birth). 2. major congenital anomalies or comorbidities likely to materially affect respiratory management or secretion clearance (for example congenital diaphragmatic hernia, major congenital pulmonary airway malformation or cyanotic congenital heart disease). 3. Neuromuscular disorders or severe hypotonia (e.g., spinal muscular atrophy) that significantly impair the ability to clear secretions from the airway. 4. Already extubated prior to enrollment or anticipated to be extubated within a few hours. 5. Duration of intubation exceeding 48 hours prior to enrolling. 6. Absence of detectable consolidation on imaging. 7. Hemodynamic instability or contraindication to routine handling: infants receiving multiple vasoactive agents at high doses or those with conditions for which repositioning is contraindicated (e.g., large sacrococcygeal teratoma). 8. Parental consent withheld or prior enrollment in this trial (no infant will be enrolled more than once).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of invasive mechanical ventilation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ventilator-free days at day 10 (VFD-10);Ventilator-free days at day 28 (VFD-28);Extubation failure;Length of hospital stay;All-cause mortality before discharge; | — |
Countries
China
Contacts
Public ContactYanfang Fan
Fujian Children’s Hospital
Outcome results
None listed