Acute Respiratory Distress Syndrome(ARDS) in Neonates

ARDS Clinical Trial

Official title:

Pregnancy Risk Factors Promote Conversion From Neonatal Respiratory Distress Syndrome(NRDS) to Acute Respiratory Distress Syndrome(ARDS) : a Observational Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03227289
• Other study ID #: ARDS
• Status: Recruiting
• Start date: August 1, 2015
• Est. completion date: December 30, 2023

Study information

• Verified date: October 2022
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: Ma Juan, MD
• Phone: 13508300283
• Email: 476679422[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Acute respiratory distress syndrome in neonates has been defined in 2015. Earlier identification and successful intervention into the potential pregnancy associated risk factors for the conversion from NRDS to ARDS is one of the most important components of ARDS prevention.

Description:

Pregnancy risk factors (PRF), such as intrahepatic cholestasis during pregnancy(ICP), hypertensive disorder complicating pregnancy(HDCP) and gestational diabetes mellitus(GDM), are related to NRDS, ARDS and subsequent death. Meantime, it has also been proven that the prevention of PRF reduces the risk of NRDS and ARDS. However, few study reported the relations between PRF and the conversion from NRDS to ARDS, and it also remains unknown whether treating PRF can reduce the progression from NRDS to ARDS.

We have found that PRF were related to the increase and deterioration of NRDS in a Chinese cohort. The aims of the present study were: 1). to report the effects of PRF on the conversion from NRDS to ARDS. 2). to clarify whether PRF treatment could prevention from conversion from NRDS to ARDS in a Chinese population.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Gender: All
• Age group: 5 Minutes to 28 Days

Eligibility

Inclusion Criteria:

1. The gestational age was less than 37 weeks;

2. These neonates were diagnosed with NRDS; The diagnosis of NRDS was based on clinical manifestations and chest X-ray findings. The clinical signs and symptoms of NRDS were respiratory distress, tachypnea, nasal flaring, groan, and cyanosis after birth. The typical X-ray picture of RDS showed a grain shadow, air bronchogram or white lung.

3. informed parental consent has been obtained

Exclusion Criteria:

1. parents' decision not to participate;

2. major congenital anomalies;

3. died or left the neonatal intensive care unit(NICU) within 24 hour.

Related Conditions & MeSH terms

• Acute Lung Injury
• ARDS
• NRDS
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Other:
• Stayed in NRDS
The neonates with NRDS are stayed in NRDS.
• Converted to ARDS
The neonates with NRDS are converted to ARDS.

Locations

Country	Name	City	State
China	Department of Pediatrics, Daping Hospital, Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the effects of Pregnancy risk factors (PRF) on the conversion from NRDS to ARDS	the effects of Pregnancy risk factors (PRF) on the conversion from NRDS to ARDS	within 28 days
Primary	clarify whether PRF treatment could prevention from conversion from NRDS to ARDS	clarify whether PRF treatment could prevention from conversion from NRDS to ARDS	within 28 days