Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00188968
Status:
COMPLETED
Last Update Posted:
2007-05-02
First Post:
2005-09-13
Brief Title:
Randomized Trial of Nasal Continuous Positive Airway Pressure or Synchronized Nasal Ventilation in Premature Infants
Sponsor:
University of Manitoba
Organization:
University of Manitoba
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None