Acute Respiratory Distress Syndrome(ARDS) in Neonates

NCT03227289 | Unknown DMC

• 1 other identifier: ARDS
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

ARDS; NRDS

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Stayed in NRDS

The neonates with NRDS are stayed in NRDS

Other: Stayed in NRDS

Converted to ARDS

The neonates with NRDS are converted to ARDS

Other: Converted to ARDS

Interventions

Stayed in NRDS OTHER

The neonates with NRDS are stayed in NRDS.

Stayed in NRDS

Converted to ARDS OTHER

The neonates with NRDS are converted to ARDS.

Converted to ARDS

Eligibility Criteria

• Age: 5 Minutes - 28 Days
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The gestational age was less than 37 weeks;

You may qualify if:

• The gestational age was less than 37 weeks;
• 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.
• informed parental consent has been obtained

You may not qualify if:

• parents' decision not to participate;
• major congenital anomalies;
• died or left the neonatal intensive care unit(NICU) within 24 hour.

Sponsors & Collaborators

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

Study Sites (1)

Department of Pediatrics, Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

Study Officials

• Shi Yuan, PhD,MD

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

  STUDY DIRECTOR

Central Study Contacts

Ma Juan, MD

CONTACT

13508300283; 476679422@qq.com

Ma Juan, MD

CONTACT

1388.559467; 476679422@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 24, 2017
• Study Start: August 1, 2015
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: October 25, 2022

Record last verified: 2022-10

Locations

CN (1)