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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03227289

Enrollment

200

Registered

2017-07-24

Start date

2015-08-01

Completion date

2023-12-30

Last updated

2022-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS, NRDS

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.

Interventions

OTHERStayed in NRDS

The neonates with NRDS are stayed in NRDS.

OTHERConverted to ARDS

The neonates with NRDS are converted to ARDS.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Minutes to 28 Days

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.

Design outcomes

Primary

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

Countries

China

Contacts

Primary ContactMa Juan, MD

476679422@qq.com13508300283

Backup ContactMa Juan, MD

476679422@qq.com1388.559467

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026