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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Apnea; Infant, Premature; Bronchopulmonary Dysplasia	Procedure: Nasal Continuous Positive Airway Pressure; Procedure: Synchronized Nasal Positive Pressure Ventilation	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	48 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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.
Study Start Date :	November 2004
Actual Study Completion Date :	February 2007

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

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Locations

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

Sponsors and Collaborators

University of Manitoba

Health Sciences Centre Foundation, Manitoba

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00188968 History of Changes
Other Study ID Numbers:	B2004:172
First Posted:	September 16, 2005
Last Update Posted:	May 2, 2007
Last Verified:	April 2007

Keywords provided by University of Manitoba:

Xanthines; Reintubation; Nasal Intermittent Ventilation; Nasal continous positive airway pressure

Additional relevant MeSH terms:

Premature Birth; Bronchopulmonary Dysplasia; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Ventilator-Induced Lung Injury	Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases