Prevention of Chronic Lung Disease (CLD) in Preterm Infants

NCT00883532 | Unknown Phase 4 DMC

• 2 other identifiers: Yeh 2009 (CMU)NHRI
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Distress Syndrome; Chronic Lung Disease of Prematurity

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Chronic lung disease morbidity among the survival

  36 postconceptional weeks

Secondary Outcomes (1)

• Neurodevelopment

  2 years of age

Study Arms (2)

budesonide

EXPERIMENTAL

The treatment group will receive surfactant and budesonide.

Drug: budesonide

surfactant and air

PLACEBO COMPARATOR

The placebo group will receive surfactant and air as control.

Drug: surfactant and air (placebo)

Interventions

budesonide DRUG

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

Also known as: pulmicort

budesonide

surfactant and air (placebo) DRUG

receive surfactant and air as control through endotracheal route

Also known as: survanta

surfactant and air

Eligibility Criteria

• Age: 30 Minutes - 4 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Severe congenital anomalities
• Lethal cardiopulmonary status at birth

Sponsors & Collaborators

• China Medical University, China: lead
• National Taiwan University Hospital: collaborator
• Taipei Medical University Hospital: collaborator
• Cathay General Hospital: collaborator
• Chang Gung Memorial Hospital: collaborator

Study Sites (1)

China Medical University

Taichung, Taiwan, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 18426851 BACKGROUND

• 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.

  PMID: 26351971 DERIVED

Related Links

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

MeSH Terms

Conditions

Respiratory Distress Syndrome; Bronchopulmonary Dysplasia; Premature Birth

Interventions

Budesonide; Surface-Active Agents; Air; beractant

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Ventilator-Induced Lung Injury; Lung Injury; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Specialty Uses of Chemicals; Chemical Actions and Uses; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Study Officials

• Tsu F Yeh, M.D.

  China Medical University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tsu F Yeh, M.D.

CONTACT

886-4-2203-4150; tfyeh@mail.ncku.edu.tw

Yu C Pan, BS

CONTACT

886-4-2203-4150; yuchenpanpan@yahoo.com.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 15, 2009
• First Posted: April 17, 2009
• Study Start: April 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: April 1, 2013
• Last Updated: August 8, 2012

Record last verified: 2009-04

Locations

CN (1)