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Clinical Trials/NCT02821273
NCT02821273
Recruiting
Not Applicable

Modified INSURE vs INSURE in Preterm Infants With Respiratory Distress Syndrome: A Randomized Controlled Trials

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University1 site in 1 country200 target enrollmentJune 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Modified INSURE Technique
Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Enrollment
200
Locations
1
Primary Endpoint
intubation rate
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

In preterm infants with respiratory distress syndrome, mechanical ventilation is related to increased risk of death and complications. Surfactant is an important methods to reduce mortality and intubation rates. INSURE technique is a standard method to administrate surfactant. However, several preterm infants need two or more surfactant, and therefore one more intubation is needed. How to reduce the times of intubation is an challenges for neonatologists.

Detailed Description

INSURE technique meas surfactant administration through intubation-surfactant-extubation. And noninvasive ventilation is immediately used after surfactant. The differences of modified INSURE compared with INSURE is intubation-surfactant-X-ray relieved-extubation. Extubation and noninvasive ventilation is used after the X-ray relieving.

Registry
clinicaltrials.gov
Start Date
June 1, 2016
End Date
December 31, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Responsible Party
Principal Investigator
Principal Investigator

Fang Wu

Principal Investigator

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

Eligibility Criteria

Inclusion Criteria

  • All preterm infants with respiratory distress syndrome

Exclusion Criteria

  • congenital abnormalities or refuse the trials

Outcomes

Primary Outcomes

intubation rate

Time Frame: 100-days

Study Sites (1)

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