Prevention of Chronic Lung Disease (CLD) in Preterm Infants

NCT ID: NCT00883532

Last Updated: 2012-08-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2013-04-30

Brief 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.

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.

Conditions

Respiratory Distress Syndrome; Chronic Lung Disease of Prematurity

Keywords

Preterm infant; Respiratory distress syndrome; chronic lung disease; budesonide; surfactant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

budesonide

The treatment group will receive surfactant and budesonide.

Group Type: EXPERIMENTAL

budesonide

Intervention Type: DRUG

budesonide, 0.25 mg/Kg/dose every 8 hours until the infant requires FIO2 \< 30% or is extubated

surfactant and air

The placebo group will receive surfactant and air as control.

Group Type: PLACEBO_COMPARATOR

surfactant and air (placebo)

Intervention Type: DRUG

receive surfactant and air as control through endotracheal route

Interventions

budesonide

budesonide, 0.25 mg/Kg/dose every 8 hours until the infant requires FIO2 \< 30% or is extubated

Intervention Type: DRUG

surfactant and air (placebo)

receive surfactant and air as control through endotracheal route

Intervention Type: DRUG

Other Intervention Names

pulmicort; survanta

Eligibility 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

• Minimum Eligible Age: 30 Minutes
• Maximum Eligible Age: 4 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: collaborator

Taipei Medical University Hospital

OTHER

Sponsor Role: collaborator

Cathay General Hospital

OTHER

Sponsor Role: collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role: collaborator

China Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

College of medicine, china medical university,Taiwan

Principal Investigators

Tsu F Yeh, M.D.

Role: PRINCIPAL_INVESTIGATOR

China Medical University, China

Locations

China Medical University

Taichung, Taiwan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Tsu F Yeh, M.D.

Role: CONTACT

Phone: 886-4-2203-4150

Email: tfyeh@mail.ncku.edu.tw

Yu C Pan, BS

Role: CONTACT

Phone: 886-4-2203-4150

Email: yuchenpanpan@yahoo.com.tw

Facility Contacts

Tsu F Yeh, M.D.

Role: primary

Yu C Pan, BS

Role: backup

References

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.

Reference Type: BACKGROUND

PMID: 18426851 (View on PubMed)

Yeh TF, Chen CM, Wu SY, Husan Z, Li TC, Hsieh WS, Tsai CH, Lin HC. Intratracheal Administration of Budesonide/Surfactant to Prevent Bronchopulmonary Dysplasia. Am J Respir Crit Care Med. 2016 Jan 1;193(1):86-95. doi: 10.1164/rccm.201505-0861OC.

Reference Type: DERIVED

PMID: 26351971 (View on PubMed)

Related Links

http://www.cmu.edu.tw

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

Other Identifiers

NHRI

Identifier Type: -

Identifier Source: secondary_id

Yeh 2009 (CMU)

Identifier Type: -

Identifier Source: org_study_id