Surfactant Administration in Preterm Infants (surfactant)

Army Medical University of People's Liberation Army

Status: Enrolling

Conditions: Modified INSURE Technique

Treatments: Other: Modified INSURE technique; Other: INSURE technique

Study type: Interventional

Funder types: Other

Identifiers

NCT02821273

INSURE technique

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: Under 6 hours old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All preterm infants with respiratory distress syndrome

Exclusion criteria

• congenital abnormalities or refuse the trials

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Modified INSURE

Experimental group

Description:

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

Treatment:

Other: Modified INSURE technique

INSURE

Active Comparator group

Description:

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

Treatment:

Other: INSURE technique