NCT02013115

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 17, 2013

Completed
1 year until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2017

Completed
Last Updated

December 7, 2017

Status Verified

December 1, 2013

Enrollment Period

2.8 years

First QC Date

December 11, 2013

Last Update Submit

December 6, 2017

Conditions

Respiratory Distress Syndrome

Keywords

infantrespiratory distress syndrome

Outcome Measures

Primary Outcomes (1)

  • need of pulmonary surfactant

    The hypothesis is Cursurf/Budesonide could reduced the need of pulmonary surfactant

    one month

Secondary Outcomes (1)

  • the incidence of bronchopulmonary dysplasia

    gestional age 36 weeks or later

Other Outcomes (1)

  • need of intubation

    one month

Study Arms (2)

Cursurf

NO INTERVENTION

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

Cursurf and Budesonide

EXPERIMENTAL

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

Drug: Budesonide

Interventions

BudesonideDRUG

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

Also known as: Pumicort
Cursurf and Budesonide

Eligibility Criteria

AgeUp to 12 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Clinical diagnosis of respiratory distress syndrome

You may not qualify if:

  • pneumothorax
  • surgical disease
  • major congenical defects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 11, 2013

First Posted

December 17, 2013

Study Start

January 1, 2015

Primary Completion

October 30, 2017

Study Completion

October 30, 2017

Last Updated

December 7, 2017

Record last verified: 2013-12

Locations

CN(1)