NHFOV vs NIPPV vs nCPAP in Preterm Infants With Respiratory Distress Syndrome

NCT03842462 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 684

Last updated 2020-11-18

No results posted yet for this study

Summary

This will be a prospective, multi-center, three-arms,parallel, randomized, controlled trial with a superiority design,conducted in China. The investigators conduct this multi-centre, randomized, controlled trial to test the hypothesis that NHFOV is more effective than nCPAP or NIPPV in the treatment of respiratory distress syndrome (RDS) in infants with a gestational age of less than 30 weeks or a birth weight of less than 1500g when used as a primary noninvasive ventilation (NIV) mode.

Conditions

  • Preterm Infant

Interventions

OTHER

nCPAP

infants receive primary non-invasive respiratory support by mean of nCPAP

OTHER

NIPPV

infants receive primary non-invasive respiratory support by mean of NIPPV

OTHER

NHFOV

infants receive primary non-invasive respiratory support by mean of NHFOV

Sponsors & Collaborators

  • Jiulongpo No.1 People's Hospital

    lead OTHER

Principal Investigators

  • Yuan Shi, PhD · Children's Hospital of Chongqing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
12 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2022-05-21
Completion
2022-05-21

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03842462 on ClinicalTrials.gov