High-Frequency Oscillation Ventilation Versus Conventional Mechanical Ventilation in Very Preterm Infants With Perinatal Acute Respiratory Distress Syndrome: Multicenters Randomized Controlled, Superiority Trial

Обзор

Bronchopulmonary dysplasia (BPD) is a complex disorder and remains the most common complication in very preterm infants. Its incidence is increased with gestational age from 95.5% among infants born at 22 weeks' gestation to 22.2% among those born at 29 weeks' gestation. BPD is associated with the increased risks of delayed neurodevelopment and pulmonary impairment. High incidences of BPD and morbidities indicate inadequacy of current management guidelines of BPD.3 Caffeine reduces the development of BPD by lowering the duration of intubation.4 How to further reduce the risk of BPD and the duration of invasive ventilation remain the key focus for neonatologists.

Подробное описание

Before 2017, the management guideline of pediatric and adult acute respiratory distress syndrome (ARDS) exclude perinatal triggers-induced ARDS. Moreover, there is insufficient evidence to recommend high-frequency oscillatory ventilation (HFOV) or conventional mechanical ventilation (CMV) as the preferred fist-line therapy in pediatric and adult ARDS. In contrast, HFOV may benefit preterm baboons with acute pulmonary dysfunction-typically due to respiratory distress syndrome (RDS)-by using low tidal volume, supra-physiologically higher respiratory rate, and lower peak inspiratory pressure to enhance oxygenation and gas exchange. The team also reported that use of HFOV is associated with a modest reduction referring to BPD. However, European consensus guideline of RDS only recommend HFOV being a reasonable alternative to CMV when high pressure is needed to achieve adequate lung inflation. Because randomized controlled trials in humans have yielded inconsistent findings.

These differences between animal models-where RDS was induced and treated with surfactant alone-and clinical scenarios, where preterm birth often involved complex etiologies requiring both surfactant and antibiotics for placental insufficiency or intrauterine infection, may be the diagnosis of RDS and ARDS or the mixture of RDS and ARDS. Such findings highlighted the lack of robust evidence for optimizing ventilation strategies in preterm infants born \<32 weeks with perinatal ARDS, and the need for well-designed multi-center randomized controlled trials in this high-risk population.

Вмешательства

• Устройство HFOV
  HFOV + volume guarantee (VG) as the intervention group HFOV was provided only with piston or membrane oscillators capable of delivering true oscillatory pressure with an active expiratory phase (i.e., Acutronic FABIAN-III, SLE 5000, Löwenstein Med LEONI+, or Sensormedics 3100A). Other machines offering high frequency ventilation were excluded. The lung recruitment maneuver was performed as previously described, and lung volume was assessed by chest radiography or lung ultrasound, targeting the r
• Устройство CMV
  CMV as the standard group CMV was delivered by time-cycled, pressure-limited ventilators. Only pressure regulated volume control (PRVC) will be provided by any type of neonatal ventilator. Crossover criteria for CMV-assigned neonates included failure for 3 hours to maintain SpO2 ≥ 50% despite FiO2 of 1.0, PaCO2 \> 60 mmHg for 3 hours, or requiring \> 30 cm H2O PIP to sustain ventilation. Non-responders to CMV were switched to HFOV. Ventilator settings were adjusted at the discretion of the att

Первичные конечные точки

• the incidence of bronchopulmonary dysplasia(BPD) [Срок оценки: 36 weeks' gestational age]

Вторичные конечные точки (7)

• duration of invasive ventilation [Срок оценки: 36 weeks' gestational age]
• mortality [Срок оценки: 36 weeks' gestational age or before discharge]
• air leak (pneumothorax and/or pneumomediastinum) occurred [Срок оценки: 36 weeks' gestational age or before discharge]
• the incidence of hemodynamically significant patent ductus arteriosus (hsPDA) [Срок оценки: 36 weeks' gestational age or before discharge]
• the incidence of retinopathy of prematurity(ROP)> 2nd grades [Срок оценки: 36 weeks' gestational age or before discharge]
• the incidence of necrotizing enterocolitis(NEC)≥2nd stages [Срок оценки: 36 weeks' gestational age or before discharge]
• intraventricular hemorrhage(IVH)>2nd grade [Срок оценки: 36 weeks' gestational age or before discharge]

Критерии участия

Критерии включения

• GA was between 24+0 and 31+6 weeks.
• Preterm neonates were admitted to NICU within 1 hours after birth, diagnosed with perinatal ARDS using Montreux guidelines and stable supported by CMV.
• Stabilization for 2 hours before randomization: FiO2 0.40, mean airway pressure (MAP) 10-14 cmH2O, ≤ 40 bpm of respiratory rate, 90%-94% of SpO2, pH > 7.20, PaCO2 60 mmHg, tidal volume of 5 ml/kg and > 35% of hematocrit (these may be evaluated by arterial blood gas analysis).

Критерии исключения

Neonates were not included if any of the following criteria were met:

• Parents or guardians' decision not to participate.
• Major congenital anomalies or chromosomal abnormalities
• Need for surgery or more than grade 2nd of IVH before randomization.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Children's Hospital of Chongqing Medical University — Чунцин

Идентификаторы

NCT: NCT03736707 · HFOV for perinatal ARDS · CSTB2024NSCQ-MSX0158

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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