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

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Brief Title

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

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.

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.
    

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 Phase

Phase 3

Study Type

Interventional


Primary Outcome

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.

Secondary Outcome

 Duration of time to methylxanthine treatment.

Condition

Apnea

Intervention

Nasal Continuous Positive Airway Pressure


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

48

Start Date

November 2004

Completion Date

February 2007


Eligibility Criteria

        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).
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Aaron Chiu, MD, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT00188968

Organization ID

B2004:172



Study Sponsor

University of Manitoba

Collaborators

 Health Sciences Centre Foundation, Manitoba

Study Sponsor

Aaron Chiu, MD, Principal Investigator, University of Manitoba


Verification Date

April 2007