Neonatal Acute Respiratory Distress Syndrome(ARDS)NCT03311165
Epidemiological Study of Neonatal Acute Respiratory Distress Syndrome (ARDS)
An observational study of Neonatal Acute Respiratory Distress Syndrome(ARDS), run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 minute to 1 month
- Conditions the study is for
- Neonatal Acute Respiratory Distress Syndrome(ARDS)
- How many people
- 1,000 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2018to 30 Jun 2019
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 1 month
- All sexes
- Child
Study population: the definition of neonatal ARDS applies to infants from birth until 44 weeks, post-menstrual age or until 4 weeks, postnatal age (for neonates born after 40 weeks, post-menstrual age) to account for the role of prematurity; ARDS in infants older than these age limits should be diagnosed according to PALICC definition
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
Department of Pediatrics, Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400042
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Chongqing
About this study
Official title: Risk Factors, Clinical Course, Treatment and Prognosis of Neonatal Acute Respiratory Distress Syndrome (ARDS): A Prospective, Observational Cohort Study
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.
Read the detailed description
In 2017, the neonatal acute respiratory distress syndrome(ARDS) Consortium Working Group has proposed diagnostic criteria for neonatal ARDS. The study consists of a prospective, multicentre, web-based,cohort study in China in which neonates who fulfil the new criteria definition are enrolled in order to: describe the epidemiology, clinical course, and prognosis of neonates affected by neonatal ARDS; identify a list of risk factors for neonatal ARDS, as it exists for adults and older children with ARDS; and guide future studies.
- Being tested
- no intervention
- Keywords
- neonate, Acute Respiratory Distress Syndrome, prognosis, risk factor, clinical course
- Medical subject headings
- Respiratory Distress Syndrome, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention was given
What is being measured
The primary outcome is the main question the study is designed to answer.
bronchopulmonary dysplasia(BPD)
the incidence of BPD in infants with neonatal ARDS
Measured: before discharge or 36 weeks' gestational age
Secondary outcomes (8)
risk factors for ARDS
to determine risk factors leading to ARDS
Measured: before discharge or 36 weeks' gestational age
death
the mortality in infants with neonatal ARDS
Measured: before discharge or 36 weeks' gestational age
epidemiological characteristics in infants with neonatal ARDS
to describe the epidemiological characteristics in infants with neonatal ARDS
Measured: before discharge or 36 weeks' gestational age
intraventricular hemorrhage（IVH）
the incidence of IVH in infants with neonatal ARDS
Measured: before discharge or 36 weeks' gestational age
retinopathy of prematurity(ROP)
the incidence of ROP in infants with neonatal ARDS
Measured: before discharge or 36 weeks' gestational age
sepsis
the incidence of sepsis in infants with neonatal ARDS
Measured: before discharge or 36 weeks' gestational age
bronchopulmonary dysplasia(BPD) and/or death
the incidence of BPD and/or death in infants with neonatal ARDS
Measured: before discharge or 36 weeks' gestational age
necrotizing enterocolitis(NEC)
the incidence of NEC in infants with neonatal ARDS
Measured: before discharge or 36 weeks' gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start1 Jan 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal Acute Respiratory Distress Syndrome(ARDS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Daping Hospital of Army Medical University, Jiulongpo No.1 People's Hospital, Children's Hospital of Chongqing Medical University, Lanzhou General Hospital of PLA, First Affiliated Hospital of Chongqing Medical University, Southwest Hospital, China, Guiyang Maternal and Child Health Care Hospital, Chengdu Women and Children's Center Hospital, Second Affiliated Hospital of Army Medical University, Zhujiang Hospital, People's Liberation Army No.202 Hospital, Bethune International Peace Hospital, The 251st hosptital of PLA, People's Hospital of Xinjiang Uygur Autonomous Region, Changhai Hospital, The PLA Rocket Force general hospital, the 252th Hospital of PLA, Hunan Children's Hospital, Wuhan general hospital of PLA, Jinan general hospital of PLA, The 306 Hospital of People's Liberation Army, The 452nd hospital of PLA, Xijing Hospital，FMMU, 307 Hospital of PLA, The 88th Hospital of PLA, Tianjin Central Hospital of Gynecology Obstetrics, Beijing 302 Hospital, First Affiliated Hospital of Xinjiang Medical University, Nanfang Hospital, Southern Medical University, Children's Hospital of Fudan University, Shanxi Provincial Maternity and Children's Hospital, the PLA General Hospital, The 155th hosptital of PLA, General Hospital of Xinjiang Military Area, Guangzhou General Hospital of Guangzhou Military Command, The 211st hospital of PLA, First Affiliated Hospital of Harbin Medical University, Maternal and Children's Healthcare Hospital of Taian, Zhengzhou Children's Hospital, China, Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, General Hospital of Shenyang Military Region, The First Affiliated Hospital of Anhui Medical University, Yan'an Affiliated Hospital of Kunming Medical University, Inner Mongolia People's Hospital, Women and Children's Hospital, Branch of Chongqing Sanxia Central Hospital, Children's Hospital of Nanjing Medical University, The First Hospital of Jilin University, Shanghai Children's Medical Center, Ningbo Women & Children's Hospital, Shandong Provincial Maternal and Child Health Care Hospital, Guilin Medical College, Women and Children Hospital of Qinghai Province, Quanzhou Children's Hospital, Ankang City Central Hospital, the Second Hospital of Xian Jiao Tong University, The Second Hospital of Shandong University, Hunan Maternal and Children Health Hospital, The First People's Hospital of Yinchuan, The First Affiliated Hospital of Zhengzhou University, The People's Hospital of Dehong Autonomous Prefecture, First people Hospital of Kashi, General Hospital of Tibet Military Region, Navy General Hospital, Beijing, Second Affiliated Hospital of Guangzhou Medical University, Jiangxi Province Children's Hospital, the Maternal and Child Health Hospital of Hainan Province, Zhang Ye Pepole Hospital of HeXi University, Shaanxi Provincial People's Hospital, Hospital (T.C.M）Affiliated to Southwest Medical University, Huazhong University of Science and Technology, South Paris University Hospitals
- Responsible party
- Principal investigator, Ma Juan, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Investigators
- Shi Yuan, PhD,MD, Principal investigator, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03311165
- Sponsor's protocol ID
- 201726
- Status last verified
- Jan 2020
- First submitted
- 4 Oct 2017
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chen L, Li J, Shi Y; Chinese Neonatal ARDS (ChiNARDS) study group. Clinical characteristics and outcomes in neonates with perinatal acute respiratory distress syndrome in China: A national, multicentre, cross-sectional study. EClinicalMedicine. 2022 Nov 12;55:101739. doi: 10.1016/j.eclinm.2022.101739. eCollection 2023 Jan.
PubMed 36386029
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors, Clinical Course, Treatment and Prognosis of Neonatal Acute Respiratory Distress Syndrome (ARDS): A Prospective, Observational Cohort Study
- ClinicalTrials.gov ID
- NCT03311165
- Acronym / sponsor ID
- 201726
- Keywords
- neonate, Acute Respiratory Distress Syndrome, prognosis, risk factor, clinical course
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Collaborators
- Daping Hospital of Army Medical University, Jiulongpo No.1 People's Hospital, Children's Hospital of Chongqing Medical University, Lanzhou General Hospital of PLA, First Affiliated Hospital of Chongqing Medical University, Southwest Hospital, China, Guiyang Maternal and Child Health Care Hospital, Chengdu Women and Children's Center Hospital, Second Affiliated Hospital of Army Medical University, Zhujiang Hospital, People's Liberation Army No.202 Hospital, Bethune International Peace Hospital, The 251st hosptital of PLA, People's Hospital of Xinjiang Uygur Autonomous Region, Changhai Hospital, The PLA Rocket Force general hospital, the 252th Hospital of PLA, Hunan Children's Hospital, Wuhan general hospital of PLA, Jinan general hospital of PLA, The 306 Hospital of People's Liberation Army, The 452nd hospital of PLA, Xijing Hospital，FMMU, 307 Hospital of PLA, The 88th Hospital of PLA, Tianjin Central Hospital of Gynecology Obstetrics, Beijing 302 Hospital, First Affiliated Hospital of Xinjiang Medical University, Nanfang Hospital, Southern Medical University, Children's Hospital of Fudan University, Shanxi Provincial Maternity and Children's Hospital, the PLA General Hospital, The 155th hosptital of PLA, General Hospital of Xinjiang Military Area, Guangzhou General Hospital of Guangzhou Military Command, The 211st hospital of PLA, First Affiliated Hospital of Harbin Medical University, Maternal and Children's Healthcare Hospital of Taian, Zhengzhou Children's Hospital, China, Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, General Hospital of Shenyang Military Region, The First Affiliated Hospital of Anhui Medical University, Yan'an Affiliated Hospital of Kunming Medical University, Inner Mongolia People's Hospital, Women and Children's Hospital, Branch of Chongqing Sanxia Central Hospital, Children's Hospital of Nanjing Medical University, The First Hospital of Jilin University, Shanghai Children's Medical Center, Ningbo Women & Children's Hospital, Shandong Provincial Maternal and Child Health Care Hospital, Guilin Medical College, Women and Children Hospital of Qinghai Province, Quanzhou Children's Hospital, Ankang City Central Hospital, the Second Hospital of Xian Jiao Tong University, The Second Hospital of Shandong University, Hunan Maternal and Children Health Hospital, The First People's Hospital of Yinchuan, The First Affiliated Hospital of Zhengzhou University, The People's Hospital of Dehong Autonomous Prefecture, First people Hospital of Kashi, General Hospital of Tibet Military Region, Navy General Hospital, Beijing, Second Affiliated Hospital of Guangzhou Medical University, Jiangxi Province Children's Hospital, the Maternal and Child Health Hospital of Hainan Province, Zhang Ye Pepole Hospital of HeXi University, Shaanxi Provincial People's Hospital, Hospital (T.C.M）Affiliated to Southwest Medical University, Huazhong University of Science and Technology, South Paris University Hospitals
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 17 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In 2017, the neonatal acute respiratory distress syndrome(ARDS) Consortium Working Group has proposed diagnostic criteria for neonatal ARDS. The study consists of a prospective, multicentre, web-based,cohort study in China in which neonates who fulfil the new criteria definition are enrolled in order to: describe the epidemiology, clinical course, and prognosis of neonates affected by neonatal ARDS; identify a list of risk factors for neonatal ARDS, as it exists for adults and older children with ARDS; and guide future studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 1 minute to 1 month
- Sex
- All
- Age groups
- Child
- Study population
- the definition of neonatal ARDS applies to infants from birth until 44 weeks, post-menstrual age or until 4 weeks, postnatal age (for neonates born after 40 weeks, post-menstrual age) to account for the role of prematurity; ARDS in infants older than these age limits should be diagnosed according to PALICC definition
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention was given | Other | – |
Primary outcome
bronchopulmonary dysplasia(BPD)
Time frame: before discharge or 36 weeks' gestational age
the incidence of BPD in infants with neonatal ARDS
8 secondary outcomes
risk factors for ARDS
Time frame: before discharge or 36 weeks' gestational age
death
Time frame: before discharge or 36 weeks' gestational age
epidemiological characteristics in infants with neonatal ARDS
Time frame: before discharge or 36 weeks' gestational age
intraventricular hemorrhage（IVH）
Time frame: before discharge or 36 weeks' gestational age
retinopathy of prematurity(ROP)
Time frame: before discharge or 36 weeks' gestational age
sepsis
Time frame: before discharge or 36 weeks' gestational age
bronchopulmonary dysplasia(BPD) and/or death
Time frame: before discharge or 36 weeks' gestational age
necrotizing enterocolitis(NEC)
Time frame: before discharge or 36 weeks' gestational age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
- Derived from this study: PubMed 36386029Chen L, Li J, Shi Y; Chinese Neonatal ARDS (ChiNARDS) study group. Clinical characteristics and outcomes in neonates with perinatal acute respiratory distress syndrome in China: A national, multicentre, cross-sectional study. EClinicalMedicine. 2022 Nov 12;55:101739. doi: 10.1016/j.eclinm.2022.101739. eCollection 2023 Jan.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shi Yuan, PhD,MD principal investigator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Acute Respiratory Distress Syndrome(ARDS), run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bronchopulmonary dysplasia(BPD) (time frame: before discharge or 36 weeks' gestational age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03311165, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2020.