Acute Respiratory Distress SyndromeNCT06188195
Establishment and Evaluation of Prenatal Prevention and Treatment Strategy for NARDS
A study testing Dexamethasone in people with Acute Respiratory Distress Syndrome and Respiratory Distress Syndrome, Acute, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
1. A predictive model for NARDS was established based on perinatal risk factors. Multivariate Logistic regression analysis was used to screen the independent prenatal risk factors for NARDS. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Respiratory Distress Syndrome, Acute
- What is being tested?
- Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The pregnant women with a probability greater than 80% in the prediction model of neonatal acute respiratory distress syndrome and agreed to ACS intervention.
- Obtaining patient consent.
Who cannot join
- the pregnant women with a probability of less than 80% in the neonatal acute respiratory distress syndrome prediction model.
- The patient refuses.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing
Li Wang, 13527499258, liwang8771@126.com
About this study
Official title: Establishment and Evaluation of Prenatal Prevention and Treatment Strategy for Neonatal Acute Respiratory Distress Syndrome
- A predictive model for NARDS was established based on perinatal risk factors. Multivariate Logistic regression analysis was used to screen the independent prenatal risk factors for NARDS. A Logistic regression model was constructed using the above independent risk factors and quantified in a nomogram to construct a visualization model for prenatal prediction of NARDS.
- The role of ACS in the prevention and treatment of ARDS in near-term/full-term infants.
For neonates with a probability greater than 80% in the prediction model of ARDS, at least one ACS was given before the termination of pregnancy. The GC level of cord blood (taken at birth) and the mRNA levels of α-ENaC, Na-K-atpase and SGK1 in nasal epithelium were measured within 2 hours and 1 day after birth in the ACS intervention group and the control group. The occurrence and severity of pulmonary edema, the occurrence and severity of ARDS, and the mortality rate of NARDS were evaluated by lung ultrasound. The indexes of the two groups were compared horizontally and longitudinally.
Read the detailed description
Based on the proposed scientific hypothesis, the project team intends to achieve the following research objectives through scientific experiments:
To explore the role of ACS in promoting fetal lung maturation from the perspective of lung fluid clearance through the traditional concept that ACS promotes fetal lung maturation mainly by inducing PS, so as to further expand the object and scope of ACS application.
The prenatal prediction model of ARDS was established by using perinatal risk factors, and the predictive value was visualized.
To explore the clinical value and mechanism of ACS in pregnant women at high risk of NARDS, and to open up new ideas for the prevention and treatment of NARDS from the perspective of promoting lung fluid clearance; The early prevention and treatment strategy of NARDS was established by combining the "prenatal prediction model +ACS", and its effect was evaluated.
- Being tested
- Dexamethasone
- Keywords
- Neonatal Acute Respiratory Distress Syndrome, Prediction nomogram, antenatal corticosteroids
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called antenatal corticosteroids
ACS intervention were used in the experimental group
| Study group | Role | What they receive |
|---|---|---|
| the experimental group | Experimental | For pregnant women with a probability greater than 80% in the prediction model of NARDS, those who agreed to ACS intervention were included in the experimental group Receives: Drug: Dexamethasone |
| the control group | No intervention | For pregnant women with a probability greater than 80% in the prediction model of NARDS, those who did not agree with ACS intervention were included in the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of neonatal acute respiratory distress syndrome
The incidence and severity of neonatal acute respiratory distress syndrome will be compared between the two groups
Measured: 1 year
The incidence and severity of pulmonary edema
The incidence and severity of pulmonary edema will be compared between the two groups
Measured: 1 year
The mortality of NARDS
The mortality rate of NARDS will be compared between the two groups
Measured: 1 year
The mRNA levels of α-ENaC, Na-K-atpase, and SGK1 in nasal epithelium
The mRNA levels of α-ENaC, Na-K-atpase, and SGK1 in nasal epithelium will be compared between the two groups
Measured: Day 0 after birth
The glucocorticoid level in cord blood
The glucocorticoid levels of cord blood will be compared between the two groups
Measured: Day 0 after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start1 Feb 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- University-Town Hospital of Chongqing Medical University, Children's Hospital of Chongqing Medical University, Chongqing Medical Center for Women and Children
- Responsible party
- Sponsor
- Investigators
- Li Wang, MD,PhD, Study chair, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188195
- Sponsor's protocol ID
- LWang
- Status last verified
- Dec 2024
- First submitted
- 27 Nov 2023
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
De Luca D, van Kaam AH, Tingay DG, Courtney SE, Danhaive O, Carnielli VP, Zimmermann LJ, Kneyber MCJ, Tissieres P, Brierley J, Conti G, Pillow JJ, Rimensberger PC. The Montreux definition of neonatal ARDS: biological and clinical background behind the description of a new entity. Lancet Respir Med. 2017 Aug;5(8):657-666. doi: 10.1016/S2213-2600(17)30214-X. Epub 2017 Jul 4.
PubMed 28687343Wang L, Chen L, Li R, Zhao J, Wu X, Li X, Shi Y. Efficacy of surfactant at different gestational ages for infants with respiratory distress syndrome. Int J Clin Exp Med. 2015 Aug 15;8(8):13783-9. eCollection 2015.
PubMed 26550326Cantarutti A, Franchi M, Monzio Compagnoni M, Merlino L, Corrao G. Mother's education and the risk of several neonatal outcomes: an evidence from an Italian population-based study. BMC Pregnancy Childbirth. 2017 Jul 12;17(1):221. doi: 10.1186/s12884-017-1418-1.
PubMed 28701151Venkatesh KK, Jackson W, Hughes BL, Laughon MM, Thorp JM, Stamilio DM. Correction: Association of chorioamnionitis and its duration with neonatal morbidity and mortality. J Perinatol. 2019 May;39(5):761. doi: 10.1038/s41372-019-0341-x.
PubMed 30842550Liu H, Li J, Guo J, Shi Y, Wang L. A prediction nomogram for neonatal acute respiratory distress syndrome in late-preterm infants and full-term infants: A retrospective study. EClinicalMedicine. 2022 Jun 25;50:101523. doi: 10.1016/j.eclinm.2022.101523. eCollection 2022 Aug.
PubMed 35784441Polnaszek B, Lopez JD, Clark R, Raghuraman N, Macones GA, Cahill AG. Marked variability in intrapartum electronic fetal heart rate patterns: association with neonatal morbidity and abnormal arterial cord gas. J Perinatol. 2020 Jan;40(1):56-62. doi: 10.1038/s41372-019-0520-9. Epub 2019 Oct 2.
PubMed 31578422Suvari L, Helve OM, Kari MA, Turpeinen LU, Palojarvi PA, Leskinen MJ, Andersson S, Janer AC. Glucocorticoids, sodium transport mediators, and respiratory distress syndrome in preterm infants. Pediatr Res. 2021 Apr;89(5):1253-1260. doi: 10.1038/s41390-020-1061-9. Epub 2020 Jul 14.
PubMed 32663837Saccone G, Berghella V. Antenatal corticosteroids for maturity of term or near term fetuses: systematic review and meta-analysis of randomized controlled trials. BMJ. 2016 Oct 12;355:i5044. doi: 10.1136/bmj.i5044.
PubMed 27733360Smith GC. Antenatal Betamethasone for Women at Risk for Late Preterm Delivery. N Engl J Med. 2016 Aug 4;375(5):486. doi: 10.1056/NEJMc1605902. No abstract available.
PubMed 27518672Sheibani L, Fong A, Henry DE, Norton ME, Truong YN, Anyikam A, Laurent LC, Rao R, Wing DA; University of California Fetal Consortium (UCfC). Maternal and neonatal outcomes after antenatal corticosteroid administration for PPROM at 32 to 33 6/7 weeks gestational age. J Matern Fetal Neonatal Med. 2017 Jul;30(14):1676-1680. doi: 10.1080/14767058.2016.1222366. Epub 2016 Aug 31.
PubMed 27578238Amiya RM, Mlunde LB, Ota E, Swa T, Oladapo OT, Mori R. Antenatal Corticosteroids for Reducing Adverse Maternal and Child Outcomes in Special Populations of Women at Risk of Imminent Preterm Birth: A Systematic Review and Meta-Analysis. PLoS One. 2016 Feb 3;11(2):e0147604. doi: 10.1371/journal.pone.0147604. eCollection 2016.
PubMed 26841022Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Plavka R, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GH, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2016 Update. Neonatology. 2017;111(2):107-125. doi: 10.1159/000448985. Epub 2016 Sep 21.
PubMed 27649091Miyazaki K, Furuhashi M, Ishikawa K, Tamakoshi K, Hayashi K, Kai A, Ishikawa H, Murabayashi N, Ikeda T, Kono Y, Kusuda S, Fujimura M. Long-term outcomes of antenatal corticosteroids treatment in very preterm infants after chorioamnionitis. Arch Gynecol Obstet. 2015 Dec;292(6):1239-46. doi: 10.1007/s00404-015-3762-6. Epub 2015 May 20.
PubMed 25990481
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment and Evaluation of Prenatal Prevention and Treatment Strategy for Neonatal Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT06188195
- Acronym / sponsor ID
- LWang
- Keywords
- Neonatal Acute Respiratory Distress Syndrome, Prediction nomogram, antenatal corticosteroids
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Collaborators
- University-Town Hospital of Chongqing Medical University, Children's Hospital of Chongqing Medical University, Chongqing Medical Center for Women and Children
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Jan 2024 (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.
- A predictive model for NARDS was established based on perinatal risk factors. Multivariate Logistic regression analysis was used to screen the independent prenatal risk factors for NARDS. A Logistic regression model was constructed using the above independent risk factors and quantified in a nomogram to construct a visualization model for prenatal prediction of NARDS.
- The role of ACS in the prevention and treatment of ARDS in near-term/full-term infants.
For neonates with a probability greater than 80% in the prediction model of ARDS, at least one ACS was given before the termination of pregnancy. The GC level of cord blood (taken at birth) and the mRNA levels of α-ENaC, Na-K-atpase and SGK1 in nasal epithelium were measured within 2 hours and 1 day after birth in the ACS intervention group and the control group. The occurrence and severity of pulmonary edema, the occurrence and severity of ARDS, and the mortality rate of NARDS were evaluated by lung ultrasound. The indexes of the two groups were compared horizontally and longitudinally.
Detailed description
Based on the proposed scientific hypothesis, the project team intends to achieve the following research objectives through scientific experiments:
To explore the role of ACS in promoting fetal lung maturation from the perspective of lung fluid clearance through the traditional concept that ACS promotes fetal lung maturation mainly by inducing PS, so as to further expand the object and scope of ACS application.
The prenatal prediction model of ARDS was established by using perinatal risk factors, and the predictive value was visualized.
To explore the clinical value and mechanism of ACS in pregnant women at high risk of NARDS, and to open up new ideas for the prevention and treatment of NARDS from the perspective of promoting lung fluid clearance; The early prevention and treatment strategy of NARDS was established by combining the "prenatal prediction model +ACS", and its effect was evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the experimental group | Experimental | Drug: DexamethasoneFor pregnant women with a probability greater than 80% in the prediction model of NARDS, those who agreed to ACS intervention were included in the experimental group |
| the control group | No intervention | –For pregnant women with a probability greater than 80% in the prediction model of NARDS, those who did not agree with ACS intervention were included in the control group |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- The pregnant women with a probability greater than 80% in the prediction model of neonatal acute respiratory distress syndrome and agreed to ACS intervention.
- Obtaining patient consent.
Key exclusion criteria (2 listed)
- the pregnant women with a probability of less than 80% in the neonatal acute respiratory distress syndrome prediction model.
- The patient refuses.
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 |
|---|---|---|
| DexamethasoneAlso: antenatal corticosteroidsACS intervention were used in the experimental group | Drug | the experimental group |
Primary outcome
The incidence and severity of neonatal acute respiratory distress syndrome
Time frame: 1 year
The incidence and severity of neonatal acute respiratory distress syndrome will be compared between the two groups
The incidence and severity of pulmonary edema
Time frame: 1 year
The incidence and severity of pulmonary edema will be compared between the two groups
The mortality of NARDS
Time frame: 1 year
The mortality rate of NARDS will be compared between the two groups
The mRNA levels of α-ENaC, Na-K-atpase, and SGK1 in nasal epithelium
Time frame: Day 0 after birth
The mRNA levels of α-ENaC, Na-K-atpase, and SGK1 in nasal epithelium will be compared between the two groups
The glucocorticoid level in cord blood
Time frame: Day 0 after birth
The glucocorticoid levels of cord blood will be compared between the two groups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Background: PubMed 28687343De Luca D, van Kaam AH, Tingay DG, Courtney SE, Danhaive O, Carnielli VP, Zimmermann LJ, Kneyber MCJ, Tissieres P, Brierley J, Conti G, Pillow JJ, Rimensberger PC. The Montreux definition of neonatal ARDS: biological and clinical background behind the description of a new entity. Lancet Respir Med. 2017 Aug;5(8):657-666. doi: 10.1016/S2213-2600(17)30214-X. Epub 2017 Jul 4.
- Background: PubMed 26550326Wang L, Chen L, Li R, Zhao J, Wu X, Li X, Shi Y. Efficacy of surfactant at different gestational ages for infants with respiratory distress syndrome. Int J Clin Exp Med. 2015 Aug 15;8(8):13783-9. eCollection 2015.
- Background: PubMed 28701151Cantarutti A, Franchi M, Monzio Compagnoni M, Merlino L, Corrao G. Mother's education and the risk of several neonatal outcomes: an evidence from an Italian population-based study. BMC Pregnancy Childbirth. 2017 Jul 12;17(1):221. doi: 10.1186/s12884-017-1418-1.
- Background: PubMed 30842550Venkatesh KK, Jackson W, Hughes BL, Laughon MM, Thorp JM, Stamilio DM. Correction: Association of chorioamnionitis and its duration with neonatal morbidity and mortality. J Perinatol. 2019 May;39(5):761. doi: 10.1038/s41372-019-0341-x.
- Background: PubMed 35784441Liu H, Li J, Guo J, Shi Y, Wang L. A prediction nomogram for neonatal acute respiratory distress syndrome in late-preterm infants and full-term infants: A retrospective study. EClinicalMedicine. 2022 Jun 25;50:101523. doi: 10.1016/j.eclinm.2022.101523. eCollection 2022 Aug.
- Background: PubMed 31578422Polnaszek B, Lopez JD, Clark R, Raghuraman N, Macones GA, Cahill AG. Marked variability in intrapartum electronic fetal heart rate patterns: association with neonatal morbidity and abnormal arterial cord gas. J Perinatol. 2020 Jan;40(1):56-62. doi: 10.1038/s41372-019-0520-9. Epub 2019 Oct 2.
- Background: PubMed 32663837Suvari L, Helve OM, Kari MA, Turpeinen LU, Palojarvi PA, Leskinen MJ, Andersson S, Janer AC. Glucocorticoids, sodium transport mediators, and respiratory distress syndrome in preterm infants. Pediatr Res. 2021 Apr;89(5):1253-1260. doi: 10.1038/s41390-020-1061-9. Epub 2020 Jul 14.
- Background: PubMed 27733360Saccone G, Berghella V. Antenatal corticosteroids for maturity of term or near term fetuses: systematic review and meta-analysis of randomized controlled trials. BMJ. 2016 Oct 12;355:i5044. doi: 10.1136/bmj.i5044.
- Background: PubMed 27518672Smith GC. Antenatal Betamethasone for Women at Risk for Late Preterm Delivery. N Engl J Med. 2016 Aug 4;375(5):486. doi: 10.1056/NEJMc1605902. No abstract available.
- Background: PubMed 27578238Sheibani L, Fong A, Henry DE, Norton ME, Truong YN, Anyikam A, Laurent LC, Rao R, Wing DA; University of California Fetal Consortium (UCfC). Maternal and neonatal outcomes after antenatal corticosteroid administration for PPROM at 32 to 33 6/7 weeks gestational age. J Matern Fetal Neonatal Med. 2017 Jul;30(14):1676-1680. doi: 10.1080/14767058.2016.1222366. Epub 2016 Aug 31.
- Background: PubMed 26841022Amiya RM, Mlunde LB, Ota E, Swa T, Oladapo OT, Mori R. Antenatal Corticosteroids for Reducing Adverse Maternal and Child Outcomes in Special Populations of Women at Risk of Imminent Preterm Birth: A Systematic Review and Meta-Analysis. PLoS One. 2016 Feb 3;11(2):e0147604. doi: 10.1371/journal.pone.0147604. eCollection 2016.
- Background: PubMed 27649091Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Plavka R, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GH, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2016 Update. Neonatology. 2017;111(2):107-125. doi: 10.1159/000448985. Epub 2016 Sep 21.
- Individual participant dataSharing planned: No
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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.
Li Wang, MD,PhD study chair
The Second Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone in people with Acute Respiratory Distress Syndrome and Respiratory Distress Syndrome, Acute, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Wang, MD,PhD (13527499258, liwang8771@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of neonatal acute respiratory distress syndrome (time frame: 1 year). The study lists 5 primary outcomes in all. 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 NCT06188195, which also lists 13 linked publications.
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 4 Jun 2025.