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.

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: Apnea; Bronchopulmonary Dysplasia; Infant, Premature
• Intervention / Treatment: Procedure: Nasal Continuous Positive Airway Pressure; Procedure: Synchronized Nasal Positive Pressure Ventilation

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): 48
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• 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

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.	7 days immediately after first extubation attempt

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• 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

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: September 13, 2005
• First Posted (Estimate): September 16, 2005

Study Record Updates

• Last Update Posted (Estimate): May 2, 2007
• Last Update Submitted That Met QC Criteria: April 30, 2007
• Last Verified: April 1, 2007

More Information

Terms related to this study

• Keywords: Reintubation; Xanthines; Nasal Intermittent Ventilation; Nasal continous positive airway pressure
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Lung Injury; Infant, Premature, Diseases; Ventilator-Induced Lung Injury; Premature Birth; Bronchopulmonary Dysplasia
• Other Study ID Numbers: B2004:172