Intubated Infants Were Intend to Extubation Using Noninvasive Ventilation Strategies Clinical Trial
Official title:
Nasal High Frequency Oscillation Ventilation(NHFOV) vs. Nasal Continuous Positive Airway Pressure(NCPAP) vs Nasal Intermittent Positive Pressure Ventilation（NIPPV） as Post-extubation Respiratory Support in Preterm Infants With Respiratory Distress Syndrome:a Multicenter Randomized Controlled Trial
| NCT number | NCT03181958 |
| Other study ID # | 201721 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | December 1, 2017 |
| Est. completion date | June 30, 2021 |
Respiratory distress syndrome (RDS) is the main cause of respiratory failure in preterm neonates, its incidence varying from 80% to 25% depending on gestational age.When optimal prenatal care is provided, the best approach to treat RDS, according to several recent trials,consists in providing continuous positive airway pressure (CPAP) from the first minutes of life using short binasal prongs or masks, followed by early selective surfactant administration for babies with worsening oxygenation and/or increasing work of breathing. Any effort should be done to minimize the time under invasive mechanical ventilation (IMV).Nonetheless, clinical trials have shown that a relevant proportion of preterm neonates fails this approach and eventually need IMV.The duration of IMV is a well known risk factor for the development of broncho-pulmonary dysplasia (BPD) - a condition associated with significant morbidity and mortality. To minimize the duration of IMV, various non invasive respiratory support modalities are available in neonatal intensive care units (NICU). CPAP is presently the most common technique used in this regard. However, a systematic review has shown that non-invasive positive pressure ventilation (NIPPV) reduces the need for IMV (within one week from extubation) more effectively than NCPAP, although it is not clear if NIPPV may reduce need for intubation longterm and it seems to have no effect on BPD and mortality. NIPPV main drawback is the lack of synchronization, which is difficult to be accurately achieved and is usually unavailable. A more recent alternative technique is non-invasive high frequency oscillatory ventilation (NHFOV) which consists on the application of a bias flow generating a continuous distending positive pressure with oscillations superimposed on spontaneous tidal breathing with no need for synchronization. The physiological, biological and clinical details about NHFOV have been described elsewhere. To date, there is only one small observational uncontrolled study about the use of NHFOV after extubation in preterm infants. Other relatively small case series or retrospective cohort studies suggested safety, feasibility and possible usefulness of NHFOV and have been reviewed elsewhere.The only randomized trial published so far compared NHFOV to biphasic CPAP,in babies failing CPAP and it has been criticized for methodological flaws and for not taking into account respiratory physiology.An European survey showed that, despite the absence of large randomized clinical trials, NHFOV is quite widely used, at least in some Countries and no major side effects are reported, although large data about NHFOV safety are lacking. This may be due to the relative NHFOV easiness of use but evidence-based and physiology-driven data are warranted about this technique.
| Status | Completed |
| Enrollment | 1493 |
| Est. completion date | June 30, 2021 |
| Est. primary completion date | May 31, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 1 Month |
| Eligibility | Inclusion Criteria: - gestational age between 25+0 and 32+6 weeks; - birth weight more than 600 g; - supported with any type of endotracheal ventilation; - Has not had first attempt at extubation(extubation readiness requires fulfilling of all the following criteria: a. Having received at least one loading dose of 20 mg/kg and 5 mg/kg daily maintenance dose of caffeine citrate; b. pH>7.20 PaCO2<=60 mmHg (these may be evaluated by arterialized capillary blood gas analysis or appropriately calibrated transcutaneous monitors. Venous blood gas values cannot be used); c. Paw <=7-8 cmH2O; d. FiO2<=0.30; e. sufficient spontaneous breathing effort, as per clinical evaluation).; - Obtained parental consent. Informed consent will be obtained antenatally or upon neonatal intensive care unit admission.; Exclusion Criteria: - major congenital anomalies or chromosomal abnormalities; - Presence of neuromuscular disease; - Upper respiratory tract abnormalities; ; - need for surgery known before the first extubation; - Grade IV-intraventricular haemorrhage (IVH) occurring before the first extubation - congenital lung diseases or malformations or pulmonary hypoplasia |
| Country | Name | City | State |
|---|---|---|---|
| China | Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | Chongqing | Chongqing |
| Lead Sponsor | Collaborator |
|---|---|
| Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | Affiliated Hospital of Southwest Medical University, Beijing 302 Hospital, Bethune International Peace Hospital, Chengdu Women and Children's Center Hospital, Children's Hospital of Chongqing Medical University, Children's Hospital of Fudan University, Children's Hospital of Nanjing Medical University, Children's Hospital of The Capital Institute of Pediatrics, Chongqing Maternal and Child Health Hospital, First Affiliated Hospital of Chongqing Medical University, First Affiliated Hospital of Guangxi Medical University, First Affiliated Hospital of Harbin Medical University, First Affiliated Hospital of Xinjiang Medical University, First Hospital of Tsinghua University, Gansu Provincial Maternity and Child-Care Hospital, Guangdong Academy of Medical Science and General Hospital, Guangdong Women and Children Hospital, Guiyang Maternal and Child Health Care Hospital, Hunan Children's Hospital, Inner Mongolia People's Hospital, Jiangxi Province Children's Hospital, Jiulongpo No.1 People's Hospital, Kunming Children's Hospital, LanZhou University, Maternal and Children's Healthcare Hospital of Taian, Mianyang Central Hospital, Nanfang Hospital of Southern Medical University, Nanjing Medical University, Ningbo Women & Children's Hospital, Peking University Third Hospital, People's Hospital of Xinjiang Uygur Autonomous Region, People's Liberation Army No.202 Hospital, Qinhuangdao Maternal and Child Health Care Hospital, Quanzhou Children's Hospital, Second Affiliated Hospital of Guangzhou Medical University, Second Hospital of Lanzhou University, Shanghai Children's Medical Center, Shanxi Provincial Maternity and Children's Hospital, Shenzhen People's Hospital, The Second Medical College of Jinan University, South Paris University Hospitals, Catholic University of the Sacred Heart, The Affiliated Hospital Of Southwest Medical University, The Children's Hospital of Zhejiang University School of Medicine, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Kunming Medical College, The First Affiliated Hospital of Zhengzhou University, The First Hospital of Jilin University, The First People's Hospital of Yunnan, the Maternal and Child Health Hospital of Hainan Province, The People's Hospital of Dehong Autonomous Prefecture, The Second Hospital of Shandong University, Third Affiliated Hospital of Zhengzhou University, Tianjin Central Hospital of Gynecology Obstetrics, Women and Children Health Care Hospitalof GuangXi Zhuang Autonomous, Women and Children Hospital of Qinghai Province, Women and Children's Health Hospital of Qujing, Women and Children's Health Hospital of Yulin, Women and Children's Hospital, Branch of Chongqing Sanxia Central Hospital, Women's Hospital School Of Medicine Zhejiang University, Wuhan Union Hospital, China, Xiamen Maternity & Child Care Hospital, Xianyang children's Hospital, Xuzhou Children Hospital, Yan'an Affiliated Hospital of Kunming Medical University, Yinchuan No 1 people's Hospital Affiliated of Ningxia Medical University, Zhengzhou Children's Hospital, China, Zhujiang Hospital, Zunyi First People's Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Duration of Invasive Mechanical Ventilation | the total days of the baby supported with the ventilator | up to 8 weeks | |
| Primary | Ventilator-free Days | non-invasive ventilation was need after extubation | up to 8 weeks | |
| Primary | Number of Babies With Reintubation | the total numbers of the baby supported with ventilator | up to 8 weeks | |
| Secondary | Number of Participants With Airleaks | airleaks was diagnosed after extubation | up to 8 weeks | |
| Secondary | Number of Participants With Bronchopulmonary Dysplasia(BPD) | Bronchopulmonary dysplasia was defined, according to National Institutes of Health (NIH) criteria, by the receipt of any form of positive-airway-pressure support or a requirement for supplemental oxygen at 36 weeks. A requirement for supplemental oxygen at 36 weeks was defined as an FiO2 of 0.30 or more or | at gestational age of 36 weeks or at discharge | |
| Secondary | Number of Participants With Retinopathy of Prematurity> 2nd Stage | Retinopathy of prematurity> 2nd stage was diagnosed after extubation | up to 8 weeks | |
| Secondary | Number of Participants With Neonatal Necrotizing Enterocolitis= 2nd Stage | Neonatal necrotizing enterocolitis= 2nd stage was diagnosed after extubation | up to 8 weeks | |
| Secondary | Number of Participants With Intraventricular Hemorrhage>2nd Grade | Intraventricular hemorrhage>2nd grade was diagnosed after extubation | up to 8 weeks | |
| Secondary | Number of Participants With Need for Postnatal Steroids | steroids was used for chronic lung disease | up to 8 weeks | |
| Secondary | In-hospital Mortality | the baby died in hospital | up to 8 weeks | |
| Secondary | Composite Mortality/BPD | the baby was dead or diagnosed with BPD. | up to 8 weeks | |
| Secondary | Weekly Weight Gain | Weekly weight gain (in grams/day) for the first 4 weeks of life or until NICU discharge, whichever comes first | during hospitalization for the first 4 weeks of life or until NICU discharge whichever came first, an average of 1 month | |
| Secondary | Haemodynamically Significant Patent Ductus Arteriosus (PDA) | hemodynamically significant patent ductus arteriosus (PDA), defined according to local NICU protocols | up to 8 weeks |