Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00433212
Status:
COMPLETED
Last Update Posted:
2014-12-05
First Post:
2007-02-07
Brief Title:
Nasal Intermittent Positive Pressure Ventilation in Premature Infants NIPPV
Sponsor:
McMaster University
Organization:
McMaster University
Study Overview
Official Title:
Efficacy and Safety of NIPPV to Increase Survival Without Bronchopulmonary Dysplasia in Extremely Low Birth Weight Infants
Status:
COMPLETED
Status Verified Date:
2014-12
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:
NIPPV
Brief Summary:
The machines and oxygen used to help very premature babies breathe can have side-effects such as bronchopulmonary dysplasia BPD Infants with BPD get more complications a higher death rate a longer time in intensive care and on assisted ventilation more hospital readmissions in the first year of life and more learning problems than infants who do not develop BPD Doctors try to remove the tube in the wind-pipe that links the baby to the breathing machine as soon as possible However small babies get tired and still require help to breathe One of the standard and common techniques to help them breathe without a tube in the wind-pipe is to use simple pressure support nasal continuous positive airway pressure or nCPAP This supports breathing a little but it is often not enough to prevent the need to go back on the breathing machine
Nasal intermittent positive pressure ventilation NIPPV is similar to nCPAP but also gives some breaths or extra support to babies through a small tube in the nose NIPPV is safe and effective and already in use as an alternate standard therapy
The main research question After being weaned from the breathing machine is NIPPV better than nCPAP in preventing BPD in premature babies weighing 999 grams or less at birth
Nasal intermittent positive pressure ventilation NIPPV is similar to nCPAP but also gives some breaths or extra support to babies through a small tube in the nose NIPPV is safe and effective and already in use as an alternate standard therapy
The main research question After being weaned from the breathing machine is NIPPV better than nCPAP in preventing BPD in premature babies weighing 999 grams or less at birth
Detailed Description:
The immature lung of extremely low birth weight ELBW 1000 g infants is easily damaged by the placement of an endotracheal tube to deliver mechanical ventilation and oxygen This and the total time of mechanical ventilation contributes to bronchopulmonary dysplasia BPD Infants with BPD have an increased risk of later death or neuro-impairment With the increasing survival of ELBW infants in the NICU there has been a proportionate increase in the number of infants surviving with BPD
Following invasive ventilation via an endotracheal tube ETT extubation to nasal Continuous Positive Airway Pressure nCPAPventilation is the standard approach Currently 40 of infants who are extubated and given nCPAP support fail and require re-intubation Previous work suggests that a less invasive respiratory support such as Nasal Intermittent Positive Pressure Ventilation NIPPV without an endotracheal tube is less injurious to the lung NIPPV may thereby reduce the duration of invasive ventilator support and aid successful early extubation We hypothesize that the use of NIPPV leads to a higher rate of survival without BPD than standard therapy with nCPAP
This randomized clinical trial is appropriately powered to compare NIPPV with nCPAP to detect effects on clinically relevant long-term outcomes such as death and BPD at 36 weeks This is a multi-national randomized open clinical trial of two different standard methods of providing non-invasive respiratory support to 1000 extremely preterm infants weighing less than 1000 grams at birth
Following invasive ventilation via an endotracheal tube ETT extubation to nasal Continuous Positive Airway Pressure nCPAPventilation is the standard approach Currently 40 of infants who are extubated and given nCPAP support fail and require re-intubation Previous work suggests that a less invasive respiratory support such as Nasal Intermittent Positive Pressure Ventilation NIPPV without an endotracheal tube is less injurious to the lung NIPPV may thereby reduce the duration of invasive ventilator support and aid successful early extubation We hypothesize that the use of NIPPV leads to a higher rate of survival without BPD than standard therapy with nCPAP
This randomized clinical trial is appropriately powered to compare NIPPV with nCPAP to detect effects on clinically relevant long-term outcomes such as death and BPD at 36 weeks This is a multi-national randomized open clinical trial of two different standard methods of providing non-invasive respiratory support to 1000 extremely preterm infants weighing less than 1000 grams at birth
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISRCTN15233270 | None | None | None |
| CIHR MCT-80246 | None | None | None |