Curosurf/Budesonide for Infants With Respiratory Distress Syndrome

Army Medical University of People's Liberation Army

Status: Completed

Conditions: Respiratory Distress Syndrome

Treatments: Drug: Budesonide

Study type: Interventional

Funder types: Other

Identifiers

NCT02013115

curosurf/Budesonide for NRDS

Details and patient eligibility

About

Infants showing high local pulmonary inflammation diagnosted by respiratory distress syndrome usually need the second or more pulmonary surfactant and is easier to developing to Brochopulmonary. Cursurf is used worldwide in infants with respiratory distress syndrome, Budesonide is a glucocorticoid with a high local anti-inflammatory effect.Our hypothesis is Cursurf combined with Budesonide could reduced the need of Cursurf and incidence of Brochopulmonary dysplasia.

Enrollment: 300 patients

Sex: All

Ages: Under 12 hours old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of respiratory distress syndrome

Exclusion criteria

• pneumothorax
• surgical disease
• major congenical defects

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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300 participants in 2 patient groups

Cursurf

No Intervention group

Description:

The baby with respiratory distress syndrome was given Cursurf through intubation.

Cursurf and Budesonide

Experimental group

Description:

The baby with respiratory distress syndrome was given Cursurf and Budesonide through intubation.

Treatment:

Drug: Budesonide