Acute Respiratory Distress Syndrome(ARDS) in Neonates

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

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.

Study Overview

• Status: Recruiting
• Conditions: ARDS; NRDS
• Intervention / Treatment: Other: Stayed in NRDS; Other: Converted to ARDS

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400042
      • Recruiting
      • Department of Pediatrics, Daping Hospital, Third Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 minutes to 4 weeks (CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The gestational age was less than 37 weeks;

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Stayed in NRDS; The neonates with NRDS are stayed in NRDS	Other: Stayed in NRDS; The neonates with NRDS are stayed in NRDS.
Converted to ARDS; The neonates with NRDS are converted to ARDS	Other: Converted to ARDS; The neonates with NRDS are converted to ARDS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2015
• Primary Completion (ANTICIPATED): December 30, 2023
• Study Completion (ANTICIPATED): December 30, 2023

Study Registration Dates

• First Submitted: July 12, 2017
• First Submitted That Met QC Criteria: July 21, 2017
• First Posted (ACTUAL): July 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 25, 2022
• Last Update Submitted That Met QC Criteria: October 23, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: ARDS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No