Establishment and Evaluation of Prenatal Prevention and Treatment Strategy for NARDS

NCT06188195 | Recruiting

• 1 other identifier: LWang
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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.
2. 2.The role of ACS in the prevention and treatment of ARDS in near-term/full-term infants.

Conditions

Acute Respiratory Distress Syndrome; Respiratory Distress Syndrome, Acute

Keywords

Neonatal Acute Respiratory Distress Syndrome; Prediction nomogram; antenatal corticosteroids

Outcome Measures

Primary Outcomes (5)

• 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

  1 year

• The incidence and severity of pulmonary edema

  The incidence and severity of pulmonary edema will be compared between the two groups

  1 year

• The mortality of NARDS

  The mortality rate of NARDS will be compared between the two groups

  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

  Day 0 after birth

• The glucocorticoid level in cord blood

  The glucocorticoid levels of cord blood will be compared between the two groups

  Day 0 after birth

Study Arms (2)

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

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

Interventions

Dexamethasone DRUG

ACS intervention were used in the experimental group

Also known as: antenatal corticosteroids

the experimental group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• the pregnant women with a probability of less than 80% in the neonatal acute respiratory distress syndrome prediction model.
• The patient refuses.

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead
• University-Town Hospital of Chongqing Medical University: collaborator
• Children's Hospital of Chongqing Medical University: collaborator
• Chongqing Medical Center for Women and Children: collaborator

Study Sites (1)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, China

RECRUITING

Related Publications (13)

• 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.

  PMID: 28687343 BACKGROUND

• Wang 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.

  PMID: 26550326 BACKGROUND

• Cantarutti 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.

  PMID: 28701151 BACKGROUND

• Venkatesh 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.

  PMID: 30842550 BACKGROUND

• Liu 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.

  PMID: 35784441 BACKGROUND

• Polnaszek 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.

  PMID: 31578422 BACKGROUND

• Suvari 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.

  PMID: 32663837 BACKGROUND

• Saccone 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.

  PMID: 27733360 BACKGROUND

• Smith 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.

  PMID: 27518672 BACKGROUND

• Sheibani 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.

  PMID: 27578238 BACKGROUND

• Amiya 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.

  PMID: 26841022 BACKGROUND

• Sweet 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.

  PMID: 27649091 BACKGROUND

• Miyazaki 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.

  PMID: 25990481 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Li Wang, MD,PhD

  The Second Affiliated Hospital of Chongqing Medical University

  STUDY CHAIR

Central Study Contacts

Li Wang, MD,PhD

CONTACT

13527499258; liwang8771@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: January 3, 2024
• Study Start: February 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 4, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)