{
  "abstract": "Abstract Objective To test the hypothesis that non-invasive high frequency oscillatory ventilation (NHFOV) is more efficacious than nasal continuous positive airway pressure (NCPAP) in reducing invasive mechanical ventilation as primary respiratory support for extremely preterm infants with respiratory distress syndrome.Design A multicentre, randomised controlled trial.Setting Twenty tertiary neonatal intensive care units in China.Participants 342 extremely preterm infants (gestational age between 24 weeks +0 day and 28 weeks +6 days) with respiratory distress syndrome were enrolled in the study between August 2022 and August 2024.Interventions Participants were randomly allocated to receive NCPAP or NHFOV as primary respiratory support for respiratory distress syndrome.Main outcome measures The primary outcome was treatment failure, defined as the need for invasive mechanical ventilation within 72 hours after birth.Results Treatment failure within 72 hours occurred in 27 of` 170 infants (15.9%) in the NHFOV group and 48 of 172 infants (27.9%) in the NCPAP group (risk difference −12.0 percentage points, 95% confidence interval −20.7 to −3.4; P=0.007). Treatment failure within seven days was also lower in the NHFOV group (−12.5 percentage points, 95% confidence interval −21.9 to −3.2; P=0.008) compared with the NCPAP group. All observed associations remained significant after sensitivity analysis including study sites and antenatal steroid use. No significant differences were found in any other secondary outcomes between the two groups.Conclusions NHFOV appeared superior to NCPAP in reducing the need for intubation when used as a primary respiratory support strategy in extremely preterm infants. Both techniques did not show significant differences in neonatal adverse events.Trial registration ClinicalTrials.gov NCT05141435",
  "authors": [
    {
      "affiliations": [
        "Department of Neonatology, Ministry of Education Key Laboratory of Child Development and Disorders, National Clinical Research Center for Child Health and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Children’s Hospital of Chongqing Medical University, Chongqing, China",
        "Chongqing Key Laboratory of Pediatrics, Chongqing, China"
      ],
      "name": "Yang Li"
    },
    {
      "affiliations": [
        "Department of Neonatology, Women and Children's Hospital of Bishan, Chongqing, China"
      ],
      "name": "Xingwang Zhu"
    },
    {
      "affiliations": [
        "Bia-Echo Asia Centre for Reproductive Longevity and Equality (ACRLE), Yong Loo Lin School of Medicine, National University of Singapore, Singapore",
        "Department of O&G, Yong Loo Lin School of Medicine, National University of Singapore, Singapore",
        "Global Centre for Asian Women’s Health (GloW), Yong Loo Lin School of Medicine, National University of Singapore, Singapore",
        "Institute for Human Development & Potential (iHDP), Agency for Science, Technology & Resrach (A*STAR), Singapore"
      ],
      "name": "Ling-Jun Li"
    },
    {
      "affiliations": [
        "Department of Neonatology, Women and Children's Hospital of Chongqing Medical University, Chongqing Health Center for Women and Children, Chongqing, China"
      ],
      "name": "Long Chen"
    },
    {
      "affiliations": [
        "Bia-Echo Asia Centre for Reproductive Longevity and Equality (ACRLE), Yong Loo Lin School of Medicine, National University of Singapore, Singapore"
      ],
      "name": "Qian Yang"
    },
    {
      "affiliations": [
        "Zhangzhou Affiliated Hospital of Fujian Medical University, Fujian, China"
      ],
      "name": "Liping Xu"
    },
    {
      "affiliations": [
        "Department of Neonatology, Women and Children's Health Hospital of Yulin, Guangxi, China"
      ],
      "name": "Wuhua Liang"
    },
    {
      "affiliations": [
        "Department of Neonatology, Maternal and Child Health Care Hospital of Xiamen, Fujian, China"
      ],
      "name": "Xinzhu Lin"
    },
    {
      "affiliations": [
        "Department of Neonatology, Women and Children's Health Hospital of Qujing, Yunan, China"
      ],
      "name": "Chuanfeng Li"
    },
    {
      "affiliations": [
        "Neonatal Intensive Care Unit, the Second Hospital of Shandong University, Shandong, China"
      ],
      "name": "Jiang Xue"
    },
    {
      "affiliations": [
        "Department of Neonatology, Guiyang Maternal and Child Health Care Hospital, Guiyang, Guizhou, China"
      ],
      "name": "Ling Liu"
    },
    {
      "affiliations": [
        "Department of Neonatology, Maternal and Children Health Care Hospital of Guangxi Zhuang Autonomous Region, Guangxi, China"
      ],
      "name": "Xinnian Pan"
    },
    {
      "affiliations": [
        "Neonatal Intensive Care Unit, the Women and Children's Center Hospital of Chengdu, Sichuan, China"
      ],
      "name": "Rong Ju"
    },
    {
      "affiliations": [
        "Hunan Maternal and Children Health Hospital, Hunan, China"
      ],
      "name": "Xianglian Peng"
    },
    {
      "affiliations": [
        "Jiangxi Maternal and Child Health Hospital, Jiangxi, China"
      ],
      "name": "Wenyan Tang"
    },
    {
      "affiliations": [
        "Department of Neonatology, Ministry of Education Key Laboratory of Child Development and Disorders, National Clinical Research Center for Child Health and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Children’s Hospital of Chongqing Medical University, Chongqing, China",
        "Chongqing Key Laboratory of Pediatrics, Chongqing, China"
      ],
      "name": "Yuan Shi"
    },
    {
      "affiliations": [],
      "name": "on behalf of the NHFOV study group"
    }
  ],
  "title": "Non-invasive high frequency oscillatory ventilation for primary respiratory support in extremely preterm infants: multicentre randomised controlled trial",
  "uid": "b0ba919a-785e-5440-b35e-f5d286624132"
}
