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Prevention of Chronic Lung Disease (CLD) in Preterm Infants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by China Medical University, China.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
National Taiwan University Hospital
Taipei Medical University Hospital
Cathay General Hospital
Chang Gung Memorial Hospital
Information provided by:
China Medical University, China
ClinicalTrials.gov Identifier:
NCT00883532
First received: April 15, 2009
Last updated: August 7, 2012
Last verified: April 2009
  Purpose

Pulmonary inflammation plays an important role in the early development of CLD. Postnatal glucocorticoids have been shown effective in the prevention or treatment of CLD with various success. However, systemic glucocorticoid therapy often associated with various short term and long term complications. Therefore, modification of the therapeutic regimen is needed. Inhaled steroid, including inhaled budesonide,have been tried but the results are essentially unsuccessful, most likely due to small airways that the inhaled steroid reaching to the peripheral lungs are limited and unpredictable. Direct instillation of budesonide into the airway has also shown to be ineffective, possibly due to poor distribution of steroid in the lungs.

The investigators hypothesize that intratracheal instillation of budesonide, a strong tropical steroid, using surfactant as vehicle would facilitate the delivery of budesonide to the lung periphery and would inhibit lung inflammation and improve the pulmonary outcome. The result of our pilot study (Pediatrics, 2008) indicated this high possibility.


Condition Intervention Phase
Respiratory Distress Syndrome
Chronic Lung Disease of Prematurity
Drug: budesonide
Drug: surfactant and air (placebo)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Prevention of Chronic Lung Disease (CLD) in Preterm Infants -A New Therapeutic Regimen

Resource links provided by NLM:


Further study details as provided by China Medical University, China:

Primary Outcome Measures:
  • Chronic lung disease morbidity among the survival [ Time Frame: 36 postconceptional weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Neurodevelopment [ Time Frame: 2 years of age ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: April 2009
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: budesonide
The treatment group will receive surfactant and budesonide.
Drug: budesonide
budesonide, 0.25 mg/Kg/dose every 8 hours until the infant requires FIO2 < 30% or is extubated
Other Name: pulmicort
Placebo Comparator: surfactant and air
The placebo group will receive surfactant and air as control.
Drug: surfactant and air (placebo)
receive surfactant and air as control through endotracheal route
Other Name: survanta

Detailed Description:

After informed consent is obtained, infant will be randomly assigned to two groups based on a double-blind design. Group I will receive surfactant and budesonide and GII will receive surfactant and air as control through endotracheal route. Therapy will be given every 8 hours until the infant require FIO2 < 30% or is extubated. The end point of assessment is the combined incidence of CLD and death judged at 36 weeks postconceptional age and the long term neurological and cognitive function at 2-3 years.

The incidence of CLD and death in the selective group of infant is about 60%. Using this 60% incidence in the placebo group and expected 40% (33% improvement) in the treated group, 130 infants in each group is needed to detected a difference, permitting a 5% chance of type I error and 10% chance of type II error. The total safe target number will be 300; 150 in each group. A collaborative study is therefore proposed. The primary outcome to be assessed is the combined incidence of CLD and death. The secondary outcome to be assessed is short term and long term side effects.

  Eligibility

Ages Eligible for Study:   up to 4 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infant with birth weight between 500-1500 gram
  • Severe respiratory distress syndrome and requires mechanical ventilation with FIO2 > 60% shortly after birth

Exclusion Criteria:

  • Severe congenital anomalities
  • Lethal cardiopulmonary status at birth
  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: NCT00883532

Contacts
Contact: Tsu F Yeh, M.D. 886-4-2203-4150 tfyeh@mail.ncku.edu.tw
Contact: Yu C Pan, BS 886-4-2203-4150 yuchenpanpan@yahoo.com.tw

Locations
China, Taiwan
China Medical University Recruiting
Taichung, Taiwan, China
Contact: Tsu F Yeh, M.D.    886-4-2203-4150    tfyeh@mail.ncku.edu.tw   
Contact: Yu C Pan, BS    886-4-2203-4150    yuchenpanpan@yahoo.com.tw   
Principal Investigator: Tsu F Yeh, M.D.         
Sponsors and Collaborators
China Medical University, China
National Taiwan University Hospital
Taipei Medical University Hospital
Cathay General Hospital
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Tsu F Yeh, M.D. China Medical University, China
  More Information

Additional Information:
Publications:
Responsible Party: Tsu F. Yeh/ Chair professor of Pediatrics, College of medicine, china medical university,Taiwan
ClinicalTrials.gov Identifier: NCT00883532     History of Changes
Other Study ID Numbers: Yeh 2009 (CMU), NHRI
Study First Received: April 15, 2009
Last Updated: August 7, 2012
Health Authority: China: Ethics Committee

Keywords provided by China Medical University, China:
Preterm infant
Respiratory distress syndrome
chronic lung disease
budesonide
surfactant

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Lung Diseases
Respiratory Distress Syndrome, Newborn
Syndrome
Disease
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Injury
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Ventilator-Induced Lung Injury
Budesonide
Pulmonary Surfactants
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014