A Phase 3 interventional study of Nasal Continuous Positive Airway Pressure and Synchronized Nasal Positive Pressure Ventilation in Apnea, Infant, Premature and Bronchopulmonary Dysplasia, sponsored by University of Manitoba. Completed at 2 sites in Canada. Per ClinicalTrials.gov, last updated 2007-05-02.
Sponsored by University of Manitoba · Phase 3, Interventional, and Treatment
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.
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.
339 studies on the registry are indexed under Bronchopulmonary Dysplasia; 80 are open to participants now.
This study's enrollment of 48 is below the median of 70 across 228 interventional studies indexed under Bronchopulmonary Dysplasia.
Browse Bronchopulmonary Dysplasia studies →University of Manitoba is the lead sponsor of 542 studies on the registry; 87 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
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Inclusion Criteria:
Exclusion Criteria:(clinical suspicion or documented diagnosis of:
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
Duration of time to methylxanthine treatment.
Time frame: During first 7 days and during hospitalization
Duration of supplemental oxygen use
Time frame: During hospitalization
Incidence of bronchopulmonary dysplasia (both 28 days of age, and 36 weeks PCA)
Time frame: 28 days of age, 36 weeks PCA
Frequency of apneas during the initial 7 days post-extubation.
Time frame: Initial 7 days post-extubation
Complications of therapy (air leak syndromes, gastric and intestinal distension).
Time frame: During Hospitalization
This study is completed, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.
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University of Manitoba