Acute Respiratory Distress Syndrome(ARDS) in Neonates

NCT ID: NCT03227289

Last Updated: 2022-10-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-08-01
• Study Completion Date: 2023-12-30

Brief 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.

Detailed 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.

Conditions

ARDS; NRDS

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Stayed in NRDS

The neonates with NRDS are stayed in NRDS

Stayed in NRDS

Intervention Type: OTHER

The neonates with NRDS are stayed in NRDS.

Converted to ARDS

The neonates with NRDS are converted to ARDS

Converted to ARDS

Intervention Type: OTHER

The neonates with NRDS are converted to ARDS.

Interventions

Stayed in NRDS

The neonates with NRDS are stayed in NRDS.

Intervention Type: OTHER

Converted to ARDS

The neonates with NRDS are converted to ARDS.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 5 Minutes
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Ma Juan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shi Yuan, PhD,MD

Role: STUDY_DIRECTOR

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

Locations

Department of Pediatrics, Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ma Juan, MD

Role: CONTACT

476679422@qq.com

13508300283

Ma Juan, MD

Role: CONTACT

476679422@qq.com

1388.559467

Facility Contacts

Juan Ma, physician

Role: primary

zoe330@163.com

18680887330

Other Identifiers

ARDS

Identifier Type: -

Identifier Source: org_study_id