Neonatal Acute Respiratory Distress Syndrome(ARDS) Clinical Trial
Official title:
Risk Factors, Clinical Course, Treatment and Prognosis of Neonatal Acute Respiratory Distress Syndrome (ARDS): A Prospective, Observational Cohort Study
| NCT number | NCT03311165 |
| Other study ID # | 201726 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 1, 2018 |
| Est. completion date | June 30, 2019 |
Neonatal acute respiratory distress syndrome(ARDS) is a rare but often severe respiratory disorder. The incidence remains unclear and mortality is about 30%-60%. It is characterized by acute, refractory hypoxemia, persistent respiratory distress and decreased lung compliance. Evaluation and comparison of various clinical studies conducted were hindered by a lack of uniformity in diagnostic criteria.
| Status | Completed |
| Enrollment | 1000 |
| Est. completion date | June 30, 2019 |
| Est. primary completion date | June 30, 2019 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | N/A to 1 Month |
| Eligibility |
Inclusion Criteria: - Acute onset (ie, within one week) from a known or suspected clinical insult - Exclusion criteria: RDS, TTN, or congenital anomalies as a primary current acute respiratory condition - Diffuse, bilateral, and irregular opacities or infiltrates, or complete opacification of the lungs, which are not fully explained by local effusions, atelectasis, RDS, TTN, or congenital anomalies - Absence of congenital heart disease explaining the oedema (this includes ductus arteriosus with pulmonary overflow if no acute pulmonary haemorrhage exists). Echocardiography is needed to verify the origin of oedema. - Mild ARDS: 4=OI<8;Moderate ARDS: 8=OI<16;Severe ARDS: OI=16 Exclusion Criteria: - Hyaline Membrane Disease defined as: Mandatory criteria : defined as respiratory distress syndrome appearing within the first 24 hours of life, with response to surfactant and / or volume recruitment. Additional criteria : Lung imaging Supporting the diagnosis and / or lamellar body counts < 30,000 / mm3. - Transient tachypnea of the neonate (wet lung) defined as: Mandatory criteria : defined as mild ( Silverman score =3 ) respiratory distress appearing within the first 24 hours of life and ending within the first 48 hours of life, needing only oxygen administration and / or CPAP. Additional criteria : Lung imaging Supporting the diagnosis and / or lamellar body counts > 30,000 / mm3. - Patients beyond the first month of life |
| Country | Name | City | State |
|---|---|---|---|
| China | Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | Chongqing | |
| China | Department of Pediatrics, Daping Hospital, Third Military Medical University | Chongqing | Chongqing |
| Lead Sponsor | Collaborator |
|---|---|
| Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | 307 Hospital of PLA, 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, Daping Hospital of Army Medical University, First Affiliated Hospital of Chongqing Medical University, First Affiliated Hospital of Harbin Medical University, First Affiliated Hospital of Xinjiang Medical University, First Hospital of Jilin University, First people Hospital of Kashi, General Hospital of Tibet Military Region, General Hospital of Xinjiang Military Area, Guangzhou general hospital of PLA, Guilin Medical College, Guiyang Maternal and Child Health Care Hospital, Hospital (T.C.M)Affiliated to Southwest Medical University, Hunan Children's Hospital, Hunan Maternal and Children Health Hospital, Inner Mongolia People's Hospital, Jiangxi Province Children's Hospital, Jinan general hospital of PLA, Jiulongpo No.1 People's Hospital, Lanzhou General Hospital of PLA, Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, Maternal and Children’s Healthcare Hospital of Taian, Nanfang Hospital of Southern Medical University, Navy General Hospital of PLA, Newborn Department of Ankang City Central Hospital of Shaanxi Province, Ningbo Women & Children's Hospital, People's Hospital of Xinjiang Uygur Autonomous Region, People's Liberation Army No.202 Hospital, Quanzhou Children's Hospital, Second Affiliated Hospital of Guangzhou Medical University, Shaanxi Provincial People's Hospital, Shandong Maternal and Child Health Hospital, Shanghai Children's Medical Center, Shanxi Provincial Maternity and Children's Hospital, Shenyang General Hospital of PLA, South Paris University Hospitals, Southwest Hospital, China, The 155th hosptital of PLA, The 211st hospital of PLA, The 251st hosptital of PLA, the 252th Hospital of PLA, The 306 Hospital of People's Liberation Army, The 452nd hospital of PLA, The 88th Hospital of PLA, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Zhengzhou University, the Maternal and Child Health Hospital of Hainan Province, The People's Hospital of Dehong Autonomous Prefecture, the PLA General Hospital, The PLA Rocket Force general hospital, The Second Affiliated Hospital of the Army Medical University, The Second Hospital of Shandong University, the Second Hospital of Xian Jiao Tong University, The Second Military Medical University Changhai Hospital, Tianjin Central Hospital of Gynecology Obstetrics, Tongji Medical College,Huazhong University of Science &Techonlogy, Women and Children Hospital of Qinghai Province, Women and Children's Hospital, Branch of Chongqing Sanxia Central Hospital, Wuhan general hospital of PLA, Xijing Hospital,FMMU, Yan’an Hospital Affiliated to Kunming Medical University, Yinchuan No.1 people Hospital, Zhang Ye Pepole Hospital of HeXi University, Zhengzhou Children's Hospital, China, Zhujiang Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | bronchopulmonary dysplasia(BPD) | the incidence of BPD in infants with neonatal ARDS | before discharge or 36 weeks' gestational age | |
| Secondary | risk factors for ARDS | to determine risk factors leading to ARDS | before discharge or 36 weeks' gestational age | |
| Secondary | death | the mortality in infants with neonatal ARDS | before discharge or 36 weeks' gestational age | |
| Secondary | epidemiological characteristics in infants with neonatal ARDS | to describe the epidemiological characteristics in infants with neonatal ARDS | before discharge or 36 weeks' gestational age | |
| Secondary | intraventricular hemorrhage(IVH) | the incidence of IVH in infants with neonatal ARDS | before discharge or 36 weeks' gestational age | |
| Secondary | retinopathy of prematurity(ROP) | the incidence of ROP in infants with neonatal ARDS | before discharge or 36 weeks' gestational age | |
| Secondary | sepsis | the incidence of sepsis in infants with neonatal ARDS | before discharge or 36 weeks' gestational age | |
| Secondary | bronchopulmonary dysplasia(BPD) and/or death | the incidence of BPD and/or death in infants with neonatal ARDS | before discharge or 36 weeks' gestational age | |
| Secondary | necrotizing enterocolitis(NEC) | the incidence of NEC in infants with neonatal ARDS | before discharge or 36 weeks' gestational age |