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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00188968
Other study ID # B2004:172
Secondary ID
Status Completed
Phase Phase 3
First received September 13, 2005
Last updated April 30, 2007
Start date November 2004
Est. completion date February 2007

Study information

Verified date April 2007
Source University of Manitoba
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.


Description:

Early extubation of premature infants may limit the deleterious effects of positive pressure ventilation. The primary cause of failure of extubation (and the need for reintubation) is apnea of prematurity. Standard treatment for improving extubation success and decreasing apnea of prematurity is with the use of nasal continuous positive airway pressure (nCPAP), use of methylxanthines, or both. Recent literature suggests that methylxanthines may have significant effect on long-term neurodevelopmental outcome.

This primary objective of this study is to investigate the effect of synchronized nasal intermittent positive pressure ventilation (sNIPPV) combined with standard nasal continuous positive airway pressure (nCPAP) versus standard nCPAP alone, on the need for reintubation and the need of methylxanthine therapy in premature infants. The study period for the primary objective will be the first 7 days immediately after the initial extubation of premature infants with birth weights 500-1250 grams. A secondary objective is to identify any differences in duration of time free of endotracheal intubation and duration of time free of methylxanthine use between the two treatment modalities as measured from the first extubation attempt.

The study is a randomized, controlled trial using a new CPAP machine (Infant Flow advanceā„¢) that will be able to provide nCPAP with and without sNIPPV. Because of the mechanics of the sNIPPV mode, blinding of the study is not possible. The study is pragmatic in design allowing the medical staff to make clinical decisions on ventilatory management based on the routinely used criteria thus evaluating the study interventions in the everyday clinical environment. Analysis will be on an intention-to-treat basis.


Recruitment information / eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
Nasal Continuous Positive Airway Pressure

Synchronized Nasal Positive Pressure Ventilation


Locations

Country Name City State
Canada Health Sciences Centre Winnipeg Manitoba
Canada St. Boniface General Hospital Winnipeg Manitoba

Sponsors (2)

Lead Sponsor Collaborator
University of Manitoba Health Sciences Centre Foundation, Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

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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