Prevention of Chronic Lung Disease (CLD) in Preterm Infants

Respiratory Distress Syndrome Clinical Trial

Official title:

Prevention of Chronic Lung Disease (CLD) in Preterm Infants -A New Therapeutic Regimen

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00883532
• Other study ID #: Yeh 2009 (CMU)
• Secondary ID: NHRI
• Status: Recruiting
• Phase: Phase 4
• First received: April 15, 2009
• Last updated: August 7, 2012
• Start date: April 2009
• Est. completion date: April 2013

Study information

• Verified date: April 2009
• Source: China Medical University, China
• Contact: Tsu F Yeh, M.D.
• Phone: 886-4-2203-4150
• Email: tfyeh[@]mail.ncku.edu.tw
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 4 Hours

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Chronic Lung Disease of Prematurity
• Lung Diseases
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Drug:
• budesonide
budesonide, 0.25 mg/Kg/dose every 8 hours until the infant requires FIO2 < 30% or is extubated
• surfactant and air (placebo)
receive surfactant and air as control through endotracheal route

Locations

Country	Name	City	State
China	China Medical University	Taichung	Taiwan

Sponsors (5)

Lead Sponsor	Collaborator
China Medical University, China	Cathay General Hospital, Chang Gung Memorial Hospital, National Taiwan University Hospital, Taipei Medical University Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Yeh TF, Lin HC, Chang CH, Wu TS, Su BH, Li TC, Pyati S, Tsai CH. Early intratracheal instillation of budesonide using surfactant as a vehicle to prevent chronic lung disease in preterm infants: a pilot study. Pediatrics. 2008 May;121(5):e1310-8. doi: 10.1542/peds.2007-1973. Epub 2008 Apr 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic lung disease morbidity among the survival		36 postconceptional weeks	Yes
Secondary	Neurodevelopment		2 years of age	Yes

External Links

•   click here for more information about the study; prevention of chronic lung disease in preterm infants--a new therapeutic regimen