An observational study in Neonatal Acute Respiratory Distress Syndrome(ARDS), sponsored by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University. Completed at 2 sites in China. Open to participants aged 1 Minute to 1 Month. Per ClinicalTrials.gov, last updated 2020-01-09.
Sponsored by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Observational
Among 11 studies in Respiratory Distress Syndrome by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University — 2 open to participants now, 2 under way, none of them phase 3. Respiratory Distress Syndrome · Daping Hospital and the Research Institute of Surgery of the Third Military Medical University.
Among the 11 studies in Respiratory Distress Syndrome by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, this one is one of 2 that started in 2018, is one of 2 observational ones, and was the 7th registered.
1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 283 are open to participants now.
This study's enrollment of 1,000 is above the median of 100 across 475 observational studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →2 of the 11 studies in Respiratory Distress Syndrome by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University are open now, in 1 country. Each count lists the studies.
Of the 193 Respiratory Distress Syndrome studies recruiting now, 118 (61%) set no upper age limit and 48 (25%) stop at 75 or younger; 51 take children under 18; 8 take healthy volunteers.
This study: 1 Minute to 1 Month · all sexes.
The full table on the hub →11 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 2 started in 2018.
Median enrollment 300 across the 9 interventional studies, 700 across the 2 observational. Of the 5 that completed or were terminated, 0 (0%) have results posted.
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University is the lead sponsor of 121 studies on the registry; 42 are open to participants now.
1 of the studies in Respiratory Distress Syndrome by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04777760Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversitySurfactant for Neonatal Respiratory Distress Syndrome(NRDS) and Neonatal Acute Respiratory Distress Syndrome(NARDS) | 2026-12-31 |
Among the 11 studies in Respiratory Distress Syndrome by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
no intervention was given
bronchopulmonary dysplasia(BPD)
the incidence of BPD in infants with neonatal ARDS
Time frame: before discharge or 36 weeks' gestational age
risk factors for ARDS
to determine risk factors leading to ARDS
Time frame: before discharge or 36 weeks' gestational age
death
the mortality in infants with neonatal ARDS
Time frame: before discharge or 36 weeks' gestational age
epidemiological characteristics in infants with neonatal ARDS
to describe the epidemiological characteristics in infants with neonatal ARDS
Time frame: before discharge or 36 weeks' gestational age
intraventricular hemorrhage（IVH）
the incidence of IVH in infants with neonatal ARDS
Time frame: before discharge or 36 weeks' gestational age
retinopathy of prematurity(ROP)
the incidence of ROP in infants with neonatal ARDS
Time frame: before discharge or 36 weeks' gestational age
sepsis
the incidence of sepsis in infants with neonatal ARDS
Time frame: 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
Time frame: before discharge or 36 weeks' gestational age
necrotizing enterocolitis(NEC)
the incidence of NEC in infants with neonatal ARDS
Time frame: before discharge or 36 weeks' gestational age
Plan to share: Undecided
Ran from Jan 2018 to primary completion in Jun 2019, 17 months.
Of 225 non-industry observational studies under Respiratory Distress Syndrome, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's 17 months is below that.
Counting every sponsor, half of 231 studies reached it within 24 months; a quarter within 12 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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