Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06295484
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-02-20
Brief Title:
Effect of Nasal CPAP Versus NIPPV On Diaphragm Electrical Activity Edi In VLBW Preterm Infants
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
Effect of Nasal Continuous Positive Airway Pressure nCPAP Versus Non-Invasive Positive Pressure Ventilation NIPPV On Diaphragm Electrical Activity Edi In Very Low Birth Weight VLBW Preterm Infants
Status:
RECRUITING
Status Verified Date:
2024-02
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:
Background
In premature babies many organ systems are not fully grown and developed including the lungs and respiratory muscles so they will need breathing support to help them to breathe by preventing their tiny air sacs to collapse This support commonly done by CPAP and Non-Invasive Positive Pressure Ventilation NIPPV therapy by giving some pressure and oxygen to their lungs through an interface placed on their noses Both CPAP and NIPPV can be used as a support modality for respiratory distress syndrome apnea of prematurity and providing breathing support after extubation from the full mechanical breathing support
The CPAP supports the babys immature lungs by delivering constant pressure to keep their lungs and breathing well supported Whereas the NIPPV will use constant pressure in the background similar to CPAP and on top it will give extra intermittent puffs at regular intervals to support the babys breathing The NIPPV is the most common choice by the clinicians when the traditional CPAP is no longer effective to avoid the full mechanical breathing support and to protect the developing lungs
Studies suggested that NIPPV is better than the traditional CPAP in reducing the need of the baby to need full mechanical breathing support This might be because the investigators tend to use lower pressures with CPAP 5-8 cmH2O compared to relatively higher pressures with NIPPV More recently clinicians showed the safety of using equivalent higher CPAP pressures 9 cmH2O to what the investigators use in the NIPPV in preterm babies
One way to measure the support that the investigators are giving to the patient with the different devices is to measure the diaphragm activity which the investigators call the Edi signal using a special feeding catheter and a specific machine to measure it The catheter is placed and used as a routine feeding tube but has sensors at the end to measure this Edi signal One opening of the tube will be connected to a computer to record the Edi signals The other opening of the tube will be used for feeding
In premature babies many organ systems are not fully grown and developed including the lungs and respiratory muscles so they will need breathing support to help them to breathe by preventing their tiny air sacs to collapse This support commonly done by CPAP and Non-Invasive Positive Pressure Ventilation NIPPV therapy by giving some pressure and oxygen to their lungs through an interface placed on their noses Both CPAP and NIPPV can be used as a support modality for respiratory distress syndrome apnea of prematurity and providing breathing support after extubation from the full mechanical breathing support
The CPAP supports the babys immature lungs by delivering constant pressure to keep their lungs and breathing well supported Whereas the NIPPV will use constant pressure in the background similar to CPAP and on top it will give extra intermittent puffs at regular intervals to support the babys breathing The NIPPV is the most common choice by the clinicians when the traditional CPAP is no longer effective to avoid the full mechanical breathing support and to protect the developing lungs
Studies suggested that NIPPV is better than the traditional CPAP in reducing the need of the baby to need full mechanical breathing support This might be because the investigators tend to use lower pressures with CPAP 5-8 cmH2O compared to relatively higher pressures with NIPPV More recently clinicians showed the safety of using equivalent higher CPAP pressures 9 cmH2O to what the investigators use in the NIPPV in preterm babies
One way to measure the support that the investigators are giving to the patient with the different devices is to measure the diaphragm activity which the investigators call the Edi signal using a special feeding catheter and a specific machine to measure it The catheter is placed and used as a routine feeding tube but has sensors at the end to measure this Edi signal One opening of the tube will be connected to a computer to record the Edi signals The other opening of the tube will be used for feeding
Detailed Description:
Our main goal in this study
To measure and compare the Edi in preterm babies requiring breathing support with CPAP or NIPPV
Inclusion Criteria Potential Candidates
This study involves stable babies who were born with a birth weight of less than 1500 grams and require CPAP
The steps of the study
The baby will be assigned to first go on traditional CPAP NIPPV or high CPAP stay for 2 hours switch to one of the other methods for 2 hours and then spend 2 hours supported by the remaining method The investigators will continue to record the Edi signals during the 3 methods
Study duration will be 6 hours from the time of catheter insertion to fit into feeding and handling plans Upon completion or termination of the study protocol the participants baby will be put back to the originally prescribed breathing support
Routine monitoring for oxygen saturation heart rate and respiratory rate will be continued as per the standard of practice in the NICU
To measure and compare the Edi in preterm babies requiring breathing support with CPAP or NIPPV
Inclusion Criteria Potential Candidates
This study involves stable babies who were born with a birth weight of less than 1500 grams and require CPAP
The steps of the study
The baby will be assigned to first go on traditional CPAP NIPPV or high CPAP stay for 2 hours switch to one of the other methods for 2 hours and then spend 2 hours supported by the remaining method The investigators will continue to record the Edi signals during the 3 methods
Study duration will be 6 hours from the time of catheter insertion to fit into feeding and handling plans Upon completion or termination of the study protocol the participants baby will be put back to the originally prescribed breathing support
Routine monitoring for oxygen saturation heart rate and respiratory rate will be continued as per the standard of practice in the NICU
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None