Bronchopulmonary Dysplasia Clinical Trial
Official title:
A Randomized, Controlled Trial of Synchronized Nasal Intermittent Positive Pressure Ventilation Versus Nasal Continuous Positive Airway Pressure Using the Infant Flow Advance to Facilitate Successful Extubation in Premature Infants.
Verified date | April 2007 |
Source | University of Manitoba |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
Very premature infants uniformly do not have mature functioning lungs to breathe well nor mature regulation mechanisms to breathe regularly. Assistance with a mechanical respirator is common. However, prolonged use of a respirator can itself cause long-term complications. Furthermore, commonly used drugs to improve the regularity of breathing may have long-term consequence only recently recognized. This study will compare two different types of assistance using a nasally applied breathing assist device. The aim is to see which type of assistance is best at avoiding the need for both prolonged respirator use and drugs to regulate breathing.
Status | Completed |
Enrollment | 48 |
Est. completion date | February 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Premature infants with birth weight 500-1250 grams - first attempt at extubation Exclusion Criteria:(clinical suspicion or documented diagnosis of: - neuromuscular disease - chromosomal abnormality - or any congenital anomalies that would affect ability to be extubated from mechanical ventilation via endotracheal tube (i.e. congenital cardiac anomalies, choanal atresia). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Health Sciences Centre | Winnipeg | Manitoba |
Canada | St. Boniface General Hospital | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
University of Manitoba | Health Sciences Centre Foundation, Manitoba |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Need for methylxanthine treatment OR the need for re-intubation in the first 7 days after the initial extubation in preterm infants intubated for treatment of respiratory distress. | 7 days immediately after first extubation attempt | ||
Secondary | Duration of time to methylxanthine treatment. | During first 7 days and during hospitalization | ||
Secondary | Duration of supplemental oxygen use | During hospitalization | ||
Secondary | Incidence of bronchopulmonary dysplasia (both 28 days of age, and 36 weeks PCA) | 28 days of age, 36 weeks PCA | ||
Secondary | Frequency of apneas during the initial 7 days post-extubation. | Initial 7 days post-extubation | ||
Secondary | Complications of therapy (air leak syndromes, gastric and intestinal distension). | During Hospitalization |
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