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High-frequency versus conventional mechanical ventilation for pulmonary hemorrhage in preterm infants: A randomized controlled trial

High-frequency versus conventional mechanical ventilation for pulmonary hemorrhage in preterm infants: A randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103973
Enrollment
Unknown
Registered
2025-06-09
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary hemorrhage in preterm infants

Interventions

HFOV Group:High-frequency oscillatory ventilation (HFOV) therapy, with parameter settings as follows: initial mean airway pressure (MAP) set at 2 cmH2O higher than the previous CMV value, frequency 10
parameters were dynamically adjusted based on oxygenation index (OI), SpO2, and PaCO2, with endotracheal bleeding assessed every 6 hours.
CMV Group:Gradually increase PEEP (1 cmH?O each time) and simultaneously adjust PIP/PS to ensure tidal volume. Dynamically adjust parameters based on the oxygenation index (OI), SpO2, and PaCO2. Asses

Sponsors

West China Second University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Preterm infants, defined as gestational age < 37 weeks. 2.Requirement for invasive mechanical ventilation. 3.Clinical diagnosis of pulmonary hemorrhage, excluding bloody tracheal secretions caused by endotracheal tube injury or other traumatic etiologies.

Exclusion criteria

Exclusion criteria: 1.Use of HFV (High-Frequency Ventilation) prior to the onset of pulmonary hemorrhage. 2.Presence of severe congenital malformations, chromosomal abnormalities, or other primary pulmonary diseases (e.g., congenital diaphragmatic hernia). 3.Patients diagnosed with Grade 3/4 intraventricular hemorrhage (IVH) before the occurrence of pulmonary hemorrhage. 4.Patients whose legal guardians refuse to provide consent for trial participation will be excluded.

Design outcomes

Primary

MeasureTime frame
Oxygenation Index ;

Secondary

MeasureTime frame
Duration of pulmonary hemorrhage;Duration of mechanical ventilation;Pulmonary air leak syndrome;Bronchopulmonary dysplasia (BPD);Mortality;Grade 3/4 intraventricular hemorrhage (IVH);Periventricular leukomalacia (PVL);

Countries

China

Contacts

Public ContactWang Hua

West China Second University Hospital

wanghua@scu.edu.cn+86 132 1908 0897

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026