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Surfactant Administration in Preterm Infants

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02821273
Acronym
surfactant
Enrollment
200
Registered
2016-07-01
Start date
2016-06-01
Completion date
2023-12-31
Last updated
2022-10-14

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

Conditions

Modified INSURE Technique

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.

Interventions

OTHERModified INSURE technique

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

OTHERINSURE technique

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 6 Hours
Healthy volunteers
No

Inclusion criteria

* All preterm infants with respiratory distress syndrome

Exclusion criteria

* congenital abnormalities or refuse the trials

Design outcomes

Primary

MeasureTime frame
intubation rate100-days

Countries

China

Contacts

Primary ContactWu Fang, MD
476679422@qq.com8613883559467

Outcome results

None listed

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