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Completed

NCT Number: NCT02013115

Curosurf/Budesonide for Infants With Respiratory Distress Syndrome

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.

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Key information

Conditions

Respiratory Distress Syndrome Lung Diseases Respiration Disorders Respiratory Tract Diseases

Age range

Up to 12 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Chongqing, Chongqing Municipality, 400042, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of respiratory distress syndrome

Exclusion criteria

  • pneumothorax
  • surgical disease
  • major congenical defects

Treatment and study plan

Budesonide

Drug

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

Other names: Pumicort

Primary outcomes

  1. need of pulmonary surfactant

    Time frame: one month

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

Secondary outcomes

  1. the incidence of bronchopulmonary dysplasia

    Time frame: gestional age 36 weeks or later

    the hypothesis is Cursurf and Budesonide could reduced the incidence of bronchopulmonary dysplasia.

Other outcomes

  1. need of intubation

    Time frame: one month

    The hypothesis is Cursurf/Budesonide could reduced the need of intubation

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: Budesonide

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 17, 2013
Registry last updated
Dec 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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