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

Surfactant Administration in Preterm Infants

Sponsors

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

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

Overall Status Recruiting
Start Date June 1, 2016
Completion Date December 1, 2021
Primary Completion Date December 1, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
intubation rate 100-days
Enrollment 200
Condition
Intervention

Intervention type: Other

Intervention name: Modified INSURE technique

Description: modified INSURE means intubation-surfactant-X-ray relieved-extubation. Extubation and noninvasive ventilation is used after the X-ray relieving.

Arm group label: Modified INSURE

Intervention type: Other

Intervention name: INSURE technique

Description: INSURE means intubation-surfactant-extubation. Extubation and noninvasive ventilation is used after surfactant administration.

Arm group label: INSURE

Eligibility

Criteria:

Inclusion Criteria:

- All preterm infants with respiratory distress syndrome

Exclusion Criteria:

- congenital abnormalities or refuse the trials

Gender: All

Minimum age: N/A

Maximum age: 6 Hours

Healthy volunteers: No

Overall Contact

Last name: Wu Fang, MD

Phone: 8613883559467

Email: [email protected]

Location
facility status contact
Department of Pediatrics,Daping Hospital Recruiting Wu Fang, MD 8613883559467 [email protected]
Location Countries

China

Verification Date

January 2020

Responsible Party

Responsible party type: Principal Investigator

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

Investigator full name: Fang Wu

Investigator title: Principal Investigator

Has Expanded Access No
Number Of Arms 2
Arm Group

Arm group label: Modified INSURE

Arm group type: Experimental

Description: Modified INSURE is intubation-surfactant-X-ray relieved-extubation. Extubation and noninvasive ventilation is used after the X-ray relieving.

Arm group label: INSURE

Arm group type: Active Comparator

Description: INSURE technique meas surfactant administration through intubation-surfactant-extubation. And noninvasive ventilation is immediately used after surfactant.

Acronym surfactant
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov