Surfactant Administration in Preterm Infants

Not Applicable

Recruiting

• Conditions: Modified INSURE Technique

• Registration Number: NCT02821273
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2016-06-01
• Study First Submitted: 2016-06-24
• Study First Submitted QC: 2016-06-30
• Study First Posted: 2016-07-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-13
• Last Update Posted: 2022-10-14
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• All preterm infants with respiratory distress syndrome

Exclusion Criteria

• congenital abnormalities or refuse the trials

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
intubation rate	100-days

Trial Locations

Locations (1)

Department of Pediatrics,Daping Hospital; 🇨🇳 Chongqing, Chongqing, China