Combined Volume Guarantee High-Frequency Oscillatory Ventilation (HFOV-VG) in Preterm Infants <32 Weeks with Respiratory Distress Syndrome (RDS): a Multicenter Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500106478

Enrollment

Unknown

Registered

2025-07-24

Start date

2025-08-20

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

Respiratory Distress Syndrome of Neonates

Interventions

Control group:ventilated with HFOV

Test group:ventilated with HFOV-VG

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Gestational age < 32 weeks; 2. Diagnosis of RDS within 72 hours after birth, , requiring tracheal intubation for both elective and rescue HFOV; 3. Informed consent from the guardians;

Exclusion criteria

Exclusion criteria: 1. Severe birth defects: severe congenital heart disease, diaphragmatic hernia, gastrointestinal malformations, congenital brain developmental abnormalities, congenital pulmonary cysts; 2. Uncorrected shock; 3. Existence of grade 3-4 IVH before ventilated; 4. Other conditions deemed unsuitable for enrollment by neonatologists;

Design outcomes

Primary

Measure	Time frame
At 36 weeks of corrected gestational age, moderate to severe bronchopulmonary dysplasia (BPD) (grade 2-3) or death.;	—

Secondary

Measure	Time frame
Death at 36 weeks of gestational age;Hemodynamic significant PDA;Weight gain rate;Necrotizing enterocolitis = stage 2;The number of doses of pulmonary surfactant replacement therapy;Retinopathy of premature;the total duration of invasive ventilation during hospitalization;air leak syndrome requiring closed thoracic drainage or pericardiocentesis, hypoxemia and bradycardia requiring cardiopulmonary compression and/or epinephrine resuscitation;Discharge against medical advice;The duration of invasive mechanical ventilation at the time of the first successful weaning from an invasive ventilator.;Late-onset sepsis;The incidence of normocapnia, hypercapnia, and hypocapnia during the intervention period;the total duration of positive pressure ventilation during hospitalization;ventilator failure, flow sensor malfunction, catheter occlusion, unplanned extubation, loose connection at the tubing joint, unplanned single-lung ventilation, air leak syndrome, ventilator-associated;The length of the first hospital stay.;BPD at 36 weeks of gestational age;Pulmonary hemorrhage, air leakage, and ventilator-associated pneumonia;Grade 3 to 4 Intraventricular hemorrage;Pulmonary hypertension (PH) requiring iNO treatment;	—

Measure

Time frame

Death at 36 weeks of gestational age;Hemodynamic significant PDA;Weight gain rate;Necrotizing enterocolitis = stage 2;The number of doses of pulmonary surfactant replacement therapy;Retinopathy of premature;the total duration of invasive ventilation during hospitalization;air leak syndrome requiring closed thoracic drainage or pericardiocentesis, hypoxemia and bradycardia requiring cardiopulmonary compression and/or epinephrine resuscitation;Discharge against medical advice;The duration of invasive mechanical ventilation at the time of the first successful weaning from an invasive ventilator.;Late-onset sepsis;The incidence of normocapnia, hypercapnia, and hypocapnia during the intervention period;the total duration of positive pressure ventilation during hospitalization;ventilator failure, flow sensor malfunction, catheter occlusion, unplanned extubation, loose connection at the tubing joint, unplanned single-lung ventilation, air leak syndrome, ventilator-associated;The length of the first hospital stay.;BPD at 36 weeks of gestational age;Pulmonary hemorrhage, air leakage, and ventilator-associated pneumonia;Grade 3 to 4 Intraventricular hemorrage;Pulmonary hypertension (PH) requiring iNO treatment;

—

Countries

China

Contacts

Public ContactShi Yuan

Children's Hospital of Chongqing Medical University

petshi530@vip.163.com+86 23 63633050

Outcome results

None listed

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