Selective High Frequency Oscillatory Ventilation (HFOV) for Neonates

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

Elective High Frequency Oscillatory Ventilation (HFOV) Versus Conventional Mechanical Ventilation(CMV) for Acute Respiratory Distress Syndrome(ARDS) and/or Respiratory Distress Syndrome(RDS) in Neonates：a Multicenter Randomized Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03736707
• Other study ID #: NARDS
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 12, 2024

Study information

• Verified date: October 2022
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Neonatal respiratory distress syndrome (RDS) remains a major respiratory disorder for the increasing preterm population, and its incidence has been confirmed to be increased gradually with decreased gestational age. Previous studies demonstrated incidences of 90% at 24 weeks', 80% at 28 weeks', 57% at 30-31 weeks', and 25% at 35-36 weeks' gestational age(GA). However, these figures were mainly performed in the pre-neonatal acute respiratory distress syndrome (ARDS) era, in which ARDS was usually considered as RDS, and surfactant was therefore used repeatedly. In fact, no studies have indicated beneficial effects of surfactant for adult and pediatric ARDS, and therefore, its exact action for neonatal ARDS was needed to be further elucidated. In 2017, the international ARDS collaborative group provided the first consensus definition for neonatal ARDS, and the exact incidence of neonatal ARDS and mortality were unknown.

Description:

Similarities to adult and pediatric ARDS, no special pharmacologic therapy for neonatal ARDS has been shown to reduce either short-term or long-term mortality and morbidity, the risk of death therefore remains high for preterm infants. Study reported that 50% chance of death with neonatal intensive care appeared at 24 weeks in most high-income countries and 34 in low-income and middle-income countries. Among the survivors, bronchopulmonary dysplasia(BPD), neurologic impairment and retinopathy of prematurity(ROP) were the main causes of secondary death, rehospitalization and medical resource use. How to reduce rate of mortality and severe complications constitutes a challenge for neonatologists. An interesting result was that HFOV did reduce the incidence of mortality as compared with CMV(2:9 vs 3:3, 95%confidence intervel(CI) 0.09-0.89, P=0.03) (4:177 vs 13:179, 95%CI 0.10-0.94, P=0.04). The results suggested that, excluding preterm infants with RDS, HFOV could also reduce other primary outcomes, such as the risk of death, BPD, IVH and neurologic impairment.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 12, 2024
• Est. primary completion date: December 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Minute to 12 Hours

Eligibility

Inclusion Criteria:

subgroup 1: For a neonate to be included, the following four criteria must be fulfilled:

1. gestational age (GA) between 26+0 and 33+6 weeks (estimated on the postmenstrual date and early gestation ultrasonographic findings);

2. birth weight less than 2000g;

3. diagnosis with ARDS and/or RDS;

4. assisted with CMV within 12 h after birth;

5. stabilization before randomization within 12 h after birth: FiO2<0.40, Paw<12 cmH2O, 90%-95% of SpO2, pH>7.20, PaCO2<60 mmHg(these may be evaluated by arterial blood gas analysis).

subgroup 2 For a neonate to be included, the following four criteria must be fulfilled:

1. gestational age (GA) more than 33+6 weeks (estimated on the postmenstrual date and early gestation ultrasonographic findings);

2. birth weight more than 2000g;

3. diagnosis with ARDS and/or RDS;

4. assisted with CMV within 12 h after birth;

5. stabilization before randomization within 12 h after birth: FiO2<0.40, Paw<12 cmH2O, 90%-95% of SpO2, pH>7.20, PaCO2<60 mmHg(these may be evaluated by arterial blood gas analysis). Exclusion Criteria:

Neonates with at least one of the following criteria are not eligible for the study:

1. neonates who only needed noninvasive ventilation;

2. major congenital anomalies or chromosomal abnormalities;

3. neuromuscular diseases;

4. upper respiratory tract abnormalities;

5. need for surgery known before the first extubation;

6. grade ?-IV-intraventricular hemorrhage (IVH);

7. congenital lung diseases or malformations or pulmonary hypoplasia.

8. parents reject to join

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• High Frequency Oscillatory Ventilation
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Device:
• Selective HFOV
Selective HFOV will only be provided with piston/membrane oscillators able to provide a real oscillatory pressure with active expiratory phase
• CMV
CMV was delivered by time-cycled, pressure-limited ventilators

Locations

Country	Name	City	State
China	Children's Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (66)

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 Kunming Medical University, First Affiliated Hospital of Xinjiang Medical University, First Hospital of Tsinghua University, Gansu Provincial Maternal and Child Health 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, 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 Hospital of Jilin University, The First People's Hospital of Yunnan, The First People's Hospital of Zunyi, 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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	death	the included neonates were dead	36 weeks' gestational age
Primary	the incidence of extracorporeal membrane oxygenation(ECMO) for neonates in group 2	the included neonates need to being supported by ECMO	36 weeks' gestational age
Primary	the incidence of bronchopulmonary dysplasia(BPD)	the included neonates were diagnosed with BPD	36 weeks' gestational age
Secondary	the incidence of retinopathy of prematurity(ROP)	the included neonates were diagnosed with ROP	36 weeks' gestational age
Secondary	the incidence of necrotizing enterocolitis(NEC)	the included neonates were diagnosed with NEC	36 weeks' gestational age
Secondary	duration of invasive ventilation	duration of invasive ventilation for HFOV or CMV	36 weeks' gestational age
Secondary	air leak (pneumothorax and/or pneumomediastinum) occurred	the included neonates were diagnosed with air leak	36 weeks' gestational age
Secondary	intraventricular hemorrhage(IVH)>2nd grade	the included neonates were diagnosed with IVH>2nd grade	36 weeks' gestational age
Secondary	composite mortality/BPD	the included neonates were diagnosed with composite mortality/BPD	36 weeks' gestational age
Secondary	the success rate of extubation	the included neonates wean from invasive ventilation	36 weeks' gestational age