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

April 30, 2007 updated by: University of Manitoba

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Manitoba
  - Winnipeg, Manitoba, Canada, R3A 1R9
    - Health Sciences Centre
  - Winnipeg, Manitoba, Canada
    - St. Boniface General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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. Time Frame: 7 days immediately after first extubation attempt	7 days immediately after first extubation attempt

Secondary Outcome Measures

Outcome Measure	Time Frame
Duration of time to methylxanthine treatment. Time Frame: During first 7 days and during hospitalization	During first 7 days and during hospitalization
Duration of supplemental oxygen use Time Frame: During hospitalization	During hospitalization
Incidence of bronchopulmonary dysplasia (both 28 days of age, and 36 weeks PCA) Time Frame: 28 days of age, 36 weeks PCA	28 days of age, 36 weeks PCA
Frequency of apneas during the initial 7 days post-extubation. Time Frame: Initial 7 days post-extubation	Initial 7 days post-extubation
Complications of therapy (air leak syndromes, gastric and intestinal distension). Time Frame: During Hospitalization	During Hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Collaborators

Health Sciences Centre Foundation, Manitoba

Investigators

Principal Investigator: Aaron Chiu, MD, University of Manitoba
Principal Investigator: Ruben Alvaro, MD, University of Mantioba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria