Randomized Trial of Nasal Continuous Positive Airway Pressure or Synchronized Nasal Ventilation in Premature Infants.

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00188968
• Other study ID #: B2004:172
• 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 advance™) 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
• 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

Related Conditions & MeSH terms

• Apnea
• Bronchopulmonary Dysplasia
• Infant, Premature
• Premature Birth

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