Surfactant Administration in Preterm Infants

NCT ID: NCT02821273

Last Updated: 2022-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Modified INSURE Technique

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Modified INSURE

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

Group Type EXPERIMENTAL

Modified INSURE technique

Intervention Type OTHER

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

INSURE

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

Group Type ACTIVE_COMPARATOR

INSURE technique

Intervention Type OTHER

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

Interventions

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Modified INSURE technique

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

Intervention Type OTHER

INSURE technique

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All preterm infants with respiratory distress syndrome

Exclusion Criteria

* congenital abnormalities or refuse the trials
Maximum Eligible Age

6 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Fang Wu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Pediatrics,Daping Hospital

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wu Fang, MD

Role: CONTACT

8613883559467

Facility Contacts

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Wu Fang, MD

Role: primary

8613883559467

Other Identifiers

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INSURE technique

Identifier Type: -

Identifier Source: org_study_id

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