Randomized Trial of Nasal Continuous Positive Airway Pressure or Synchronized Nasal Ventilation in Premature Infants.
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.
1 other identifier
interventional
48
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 2004
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedMay 2, 2007
April 1, 2007
September 13, 2005
April 30, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Duration of time to methylxanthine treatment.
During first 7 days and during hospitalization
Duration of supplemental oxygen use
During hospitalization
Incidence of bronchopulmonary dysplasia (both 28 days of age, and 36 weeks PCA)
28 days of age, 36 weeks PCA
Frequency of apneas during the initial 7 days post-extubation.
Initial 7 days post-extubation
Complications of therapy (air leak syndromes, gastric and intestinal distension).
During Hospitalization
Interventions
Eligibility Criteria
You may qualify if:
- Premature infants with birth weight 500-1250 grams
- first attempt at extubation
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aaron Chiu, MD
University of Manitoba
- PRINCIPAL INVESTIGATOR
Ruben Alvaro, MD
University of Mantioba
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 16, 2005
Study Start
November 1, 2004
Study Completion
February 1, 2007
Last Updated
May 2, 2007
Record last verified: 2007-04