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Glucocorticoid Therapy Impact on the Inflammatory Response and Clinical Evolution in Patients With Severe Bronchiolitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fundació Sant Joan de Déu
ClinicalTrials.gov Identifier:
NCT02571517
First received: September 29, 2015
Last updated: October 7, 2015
Last verified: October 2015
  Purpose
The purpose of this study is to to demonstrate that a 7-day course of systemic glucocorticoids decreases the inflammatory activity of moderate or severe bronchiolitis in paediatric patients compared to the standard treatment. To evaluate the morbidity (regarding to the clinical course: Intensive Pediatric Unit Care unit (PICU) admission, mechanical ventilation, ionotropic support, nosocomial infection, rescue therapy for respiratory failure; duration of PICU stay and hospitalization; and exitus) between the treatment and the control groups.

Condition Intervention Phase
Bronchiolitis, Viral Drug: Glucocorticoids Other: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Impact of the Administration of Systemic Glucocorticoids on Inflammatory Response and Clinical Evolution of Patients Diagnosed With Moderate- Severe Bronchiolitis

Resource links provided by NLM:


Further study details as provided by Fundació Sant Joan de Déu:

Primary Outcome Measures:
  • Change from Baseline in inflammatory response [ Time Frame: enrollment to one week treatment ]
    inflammatory response evaluation of the first week of glucocorticoids treatment as assessed by multiple measurements aggregated to arrive at one reported value, which are: the bronchiolitis clinical severity Scale, pediatric mortality Risk scale (PRISM III), the Chest x-ray test, the nasopharyngeal aspiration and analytical exploration (at day 5-7)

  • Morbidity episodes [ Time Frame: 14 months ]
    Morbidity assessment by multiple measurements aggregated to arrive at one reported value which are as follow: necessity of mechanical ventilation, inotropic, presence of nosocomial infection, rescue therapies if respiratory failure occur; days of admission to the Pediatric Intensive Care Unit and hospitalization, in both treatment and control groups


Secondary Outcome Measures:
  • Number of Side effects estimate [ Time Frame: 14 months ]
    Number of Side effects estimate by comparing the experimental group to the control group


Enrollment: 94
Study Start Date: November 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glucocorticoids

methylprednisolone intravenous administration of 2mg/kg/day (divided in two doses) and/or oral prednisolone 2,5 mg/kg/day (in two divided doses) during 7 days.

Patients younger than 2 year, who required hospitalization, affected by moderate or severe bronchiolitis

Drug: Glucocorticoids
Patients assigned to experimental group (group 1) will receive iv methylprednisolone 2 mg/kg/day (divided in two doses) doses and/or oral prednisolone 2,5 mg/kg/day (divided in two doses) during 7 days.
Other Names:
  • SOLU-MODERIN 125 mg
  • METHYLPREDNISOLONE SODIUM SUCCINATE
  • ESTILSONA Gotas
Placebo Comparator: Placebo

will receive iv/oral glucose 5% solution as placebo of 2mg/kg/day and/or 2,5 mg/kg/day (divided in two doses) during 7 days.

Patients younger than 2 year, who required hospitalization, affected by moderate or severe bronchiolitis.

Other: Placebo
Patients assigned to control group (group 2) will receive iv/oral glucose 5% solution as placebo, 2 mg/kg/day (divided in two doses) during 7 days.
Other Names:
  • glucose 5% solution
  • Plast-Apyr Glucosado 5%

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

The study will recruit paediatric patients younger than one year old who require hospitalization for moderate-severe bronchiolitis according to the BRONCHIOLITIS SCORE of Sant Joan de Deu Hospital (HSJD)

Exclusion Criteria:

  • Patients of either gender under one year old with mild bronchiolitis.
  • Patients with bronchiolitis in which the principal symptom is apnoea.
  • Patients who have received corticotherapy before admission to hospital.
  • No consent from parents or tutors.
  • Patients with previous acquired or innate immunodepression.
  • Patients enrolled in other clinical trials.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02571517

Sponsors and Collaborators
Fundació Sant Joan de Déu
Investigators
Principal Investigator: Iolanda Jordán, MD UCIP H Sant Joan de Déu
  More Information

Publications:
Responsible Party: Fundació Sant Joan de Déu
ClinicalTrials.gov Identifier: NCT02571517     History of Changes
Other Study ID Numbers: FSJD-GLUCOBR-2010
2011-000337-36 ( EudraCT Number )
Study First Received: September 29, 2015
Last Updated: October 7, 2015

Keywords provided by Fundació Sant Joan de Déu:
Respiratory viral infection.
Respiratory syncytial virus bronchiolitis
METHYLPREDNISOLONE SODIUM SUCCINATE

Additional relevant MeSH terms:
Bronchiolitis
Bronchiolitis, Viral
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Virus Diseases
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Glucocorticoids
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 25, 2017