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Curosurf/Budesonide for Infants With Respiratory Distress Syndrome

Curosurf/Budesonide for Infants With Respiratory Distress Syndrome

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02013115
Acronym
Budesonide
Enrollment
300
Registered
2013-12-17
Start date
2015-01-01
Completion date
2017-10-30
Last updated
2017-12-07

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

Conditions

Respiratory Distress Syndrome

Keywords

infant, respiratory distress syndrome

Brief summary

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.

Interventions

DRUGBudesonide

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 12 Hours
Healthy volunteers
No

Inclusion criteria

* Clinical diagnosis of respiratory distress syndrome

Exclusion criteria

* pneumothorax * surgical disease * major congenical defects

Design outcomes

Primary

MeasureTime frameDescription
need of pulmonary surfactantone monthThe hypothesis is Cursurf/Budesonide could reduced the need of pulmonary surfactant

Secondary

MeasureTime frameDescription
the incidence of bronchopulmonary dysplasiagestional age 36 weeks or laterthe hypothesis is Cursurf and Budesonide could reduced the incidence of bronchopulmonary dysplasia.

Other

MeasureTime frameDescription
need of intubationone monthThe hypothesis is Cursurf/Budesonide could reduced the need of intubation

Countries

China

Outcome results

None listed

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