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NCT Number: NCT07377955

Combined Oscillation-Volume guarantEe Study

Respiratory Distress Syndrome (RDS) remains the most common respiratory complication in the early postnatal period among preterm infants born before 32 weeks' gestational age. For this population, implementing lung-protective ventilation strategies is essential to shorten the duration of intubation, reduce the incidence and severity of bronchopulmonary dysplasia (BPD), lower mortality, and improve overall outcomes.

HFOV-VG was first reported in 2015 to be safely applied in neonates. The fundamental principle lies in its ability to stabilize the tidal volume of high-frequency ventilation (VThf), thereby reducing sheer stress from amplitude fluctuations, while simultaneously permitting lower VThf settings to minimize volutrauma.

This study aims to evaluate whether HFOV+VG is superior to HFOV in reducing the composite outcome of grade 2-3 BPD or death at 36 weeks' post-menstrual age (PMA).

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Key information

Conditions

Respiratory Distress Syndrome (& [Hyaline Membrane Disease]) Bronchopulmonary Dysplasia Bronchopulmonary Dysplasia (BPD) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hyaline Membrane Disease Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Respiration Disorders Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Respiratory Tract Diseases Ventilator-Induced Lung Injury

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gestational age 24+0/7< 320/7 weeks
  • Diagnosis of RDS within 72 hours after birth, requiring endotracheal ventilation for both elective and rescue HFOV

Exclusion criteria

  • Severe birth defects: severe congenital heart disease, diaphragmatic hernia, gastrointestinal malformations, congenital brain developmental abnormalities, congenital pulmonary cysts
  • Uncorrected shock
  • Existence of grade 3-4 IVH before ventilated
  • Other conditions deemed unsuitable for enrollment by neonatologists, including endotracheal intubation performed specifically for the purpose of the INSURE or INRECSURE technique.

Treatment and study plan

HFOV

Device

HFOV: 1) Mean airway pressure (MAP) and FiO2: titrated via oxygenation-guided lung recruitment maneuvers to maintain preductal SpO2 target of 89%-94%. 2) Frequency: 12-15 Hz for birth weight (BW)<1500g, and 10-12 Hz for BW≥ 1500g. 3) I:E ratio: 1:1 or 1:2 according to recommendations of manufacturers and local habits

HFOV+VG

Device

HFOV-VG Group: ①VThf: <1000g 1.5-1.8ml/kg, 1000-1500g 1.8-2.2ml/kg, >1500g, 2.2-2.5ml/kg; ②Amplitude automatically adjusted by volume guarantee algorithm and the upper limit was set at 15% above the measured value after achieving the target VThf, with the constraint that it must not exceed 20 cm H2O for BW<1000g, 25cm H2O for BW 1000-1500g or 25-30 cmH2O for BW>1500g; ③If the target VThf is not achieved after the amplitude has reached its upper limit, airway issues (e.g., suctioning) or lung recruitment should be addressed first, rather than overriding the amplitude limit

Primary outcomes

  1. Composite outcome of grade 2-3 BPD or in-hospital death at 36 weeks' PMA

    Time frame: 36 weeks gestational age

Secondary outcomes

  1. In-hospital death at 36 weeks' PMA

    Time frame: 36 weeks gestational age

  2. The incidence of BPD at 36 weeks' PMA

    Time frame: 36 weeks gestational age

  3. The duration of invasive ventilation at the time of the first successful extubation

    Time frame: through study completion, an average of 1 year

  4. Surfactant doses

    Time frame: through study completion, an average of 1 year

  5. The incidence of normocapnia, hypercapnia, and hypocapnia during the intervention period

    Time frame: through study completion, an average of 1 year

  6. Pulmonary hypertension (PH) requiring iNO treatment, including PPHN within 7 days after birth and cPH after 28 days of life

    Time frame: through study completion, an average of 1 year

  7. hsPDA (Iowa score ≥6 )

    Time frame: through study completion, an average of 1 year

  8. The incidence of massive pulmonary hemorrhage, pneumothorax, pneumomediastinum, pneumopericardium, and ventilator-associated pneumonia(VAP)

    Time frame: through study completion, an average of 1 year

  9. The incidence of Grade III to IV IVH according to Papile 1978 criteria

    Time frame: through study completion, an average of 1 year

  10. The incidence of Necrotizing enterocolitis (NEC) > grade II according to Modified Bell's Staging Criteria

    Time frame: through study completion, an average of 1 year

  11. The incidence of Culture-proven late-onset sepsis (onset after 72 hours of life)

    Time frame: through study completion, an average of 1 year

  12. The incidence of Retinopathy of premature > grade II

    Time frame: through study completion, an average of 1 year

  13. The duration of hospitalization

    Time frame: through study completion, an average of 1 year

  14. Weight gain (g/kg/day)

    Time frame: through study completion, an average of 1 year

  15. The incidence of discharge against medical advice (DAMA)

    Time frame: through study completion, an average of 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Yuan Shi, PhD

CONTACT

[email protected]

+86 23 68757731

Sponsors and collaborators

Lead sponsor

Xingwang Zhu

Other

Collaborators

  • Affiliated Hospital of Jining Medical University
  • Children's Hospital of Chongqing Medical University
  • Chongqing Qianjiang Central Hospital
  • First People's Hospital of Chenzhou
  • Fujian Maternity and Child Health Hospital
  • Fuling Hospital of Chongqing University
  • Guangdong Women and Children Hospital
  • Hunan Children's Hospital
  • Hunan Provincial Maternal and Child Health Care Hospital
  • Hunan Provincial People's Hospital
  • Inner Mongolia Maternal and Child Health Care Hospital
  • Jiangxi Maternal and Child Health Hospital
  • Kunming Children's Hospital
  • Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region
  • Moscow Regional Research Institute of Obstetrics and Gynecology named after Academician V. I. Krasnopolsky
  • Northwest Women's and Children's Hospital, Xi'an, Shaanxi
  • People's Hospital of MeiShan
  • QuanZhou Women and Children's Hospital
  • Qujing Maternal and Child Hospital
  • Second Affiliated Hospital of Wenzhou Medical University
  • Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University
  • Shanxi Women and Children Hospital
  • Shenzhen Longhua Maternity and Child Health Care Hospital
  • Shijiazhuang Obstetrics and Gynecology Hospital
  • The Affiliated Hospital of Inner Mongolia Medical University
  • The Third Affiliated Hospital of Guangzhou Medical University
  • Women and Children's Hospital of Ningbo University
  • Zhangzhou Affiliated Hospital of Fujian Medical School
  • Zhengzhou Children's Hospital, China

Registry information

Official study title

Combined Volume Guarantee High-Frequency Oscillatory Ventilation (HFOV-VG) Versus Conventional High-Frequency Oscillatory Ventilation (HFOV) on Grade 2 to 3 Bronchopulmonary Dysplasia (BPD) or Death in Preterm Infants <32 Weeks With Respiratory Distress Syndrome (RDS)

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 30, 2026
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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