Ignite Creation Date:
2024-05-06 @ 2:56 AM
Last Modification Date:
2024-10-26 @ 11:26 AM
Study NCT ID:
NCT02164734
Status:
TERMINATED
Last Update Posted:
2023-09-21
First Post:
2014-06-13
Brief Title:
Surfactant Via Endotracheal Tube vs Laryngeal Mask Airway LMA in Preterm Neonates With Respiratory Distress Syndrome
Sponsor:
Albany Medical College
Organization:
Albany Medical College
Study Overview
Official Title:
Efficacy of Rescue Surfactant Delivery Via Endotracheal Intubation INSURE Technique Versus Laryngeal Mask Airway LMA for Respiratory Distress Syndrome RDS in Preterm Neonates
Status:
TERMINATED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow to impossible recruitment during COVID-19 pandemic
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study newborn babies with respiratory distress syndrome RDS receiving oxygen via nasal continuous airway pressure CPAP modalities and needing surfactant treatment will be randomized to standard delivery of surfactant via and endotracheal tube airway inserted after pre-medication for pain with a short-acting narcotic or to surfactant delivery via laryngeal mask airway LMA The intent is to remove the airways and return babies to non-invasive CPAP support after surfactant is given The primary outcome measure is the rate of failure of initial surfactant therapy Standardized failure criteria are reached a early if the baby is unable to be placed back on non-invasive CPAP ie needs tracheal intubation and mechanical ventilation or b late if the baby requires ventilation retreatment with surfactant within 8 hours or more than 2 doses of surfactant
The objective of this protocol is to reduce the need for endotracheal intubation and mechanical ventilation in preterm neonates with RDS needing rescue surfactant therapy by instilling surfactant though an LMA while achieving comparable efficacy of surfactant treatment
The hypothesis is that surfactant treatment through an LMA will decrease the proportion of babies with RDS who require mechanical ventilation or subsequent intubation when compared to standard surfactant treatment following endotracheal intubation with sedation
The objective of this protocol is to reduce the need for endotracheal intubation and mechanical ventilation in preterm neonates with RDS needing rescue surfactant therapy by instilling surfactant though an LMA while achieving comparable efficacy of surfactant treatment
The hypothesis is that surfactant treatment through an LMA will decrease the proportion of babies with RDS who require mechanical ventilation or subsequent intubation when compared to standard surfactant treatment following endotracheal intubation with sedation
Detailed Description:
Respiratory Distress Syndrome RDS due to deficiency of pulmonary surfactant is common in preterm newborns Early treatment with surfactant improves oxygenation reduces the need for subsequent mechanical ventilation decreases the incidence of pulmonary air leaks and chronic lung disease and it also reduces mortality in extremely premature newborns Optimal treatment of RDS includes surfactant therapy and avoidance of invasive mechanical ventilation by using nasal continuous positive airway pressure modes NCPAP or NIPPV The current standard method of surfactant delivery requires tracheal intubation and at least brief positive-pressure ventilation as in the INSURE Intubation-Surfactant-Extubation approach Because tracheal intubation causes pain and vagal-mediated physiologic instability in neonates premedication with atropine and a narcotic is recommended However narcotic premedication increases respiratory depression which may require sustained mechanical ventilation thus contributing to the failure of INSURE In a recent trial at our center standard pretreatment with morphine and atropine was associated with failure of INSURE in more than 23 of patients Consequently we have recently changed our standard premedication for INSURE to the combination of atropine and remifentanil a rapid onset short-acting narcotic The Laryngeal Mask Airway LMA is a commercially available less invasive artificial airway that does not need to be inserted into the trachea it is FDA-approved for use in neonates preliminary data suggest that it can be used for surfactant administration which in our trial was associated with a lower failure rate than the morphine plus INSURE approach
The main objective of this study protocol is reduce the need for endotracheal intubation and mechanical ventilation in preterm neonates with mild to moderate RDS needing rescue surfactant therapy by instilling surfactant though an LMA A second objective is to compare the efficacy of surfactant administered via LMA versus endotracheal tube ETT in decreasing the severity of RDS Additionally we will further evaluate the safety of surfactant administration via LMA
The primary hypothesis is that surfactant therapy delivered via LMA is not inferior to surfactant therapy delivered via transient intubation INSURE technique with short-acting narcotic premedication for mild to moderate RDS in preterm neonates
This randomized controlled trial will include babies with mild-to-moderate RDS less than 48 hours of age with gestational age 27 07 to 36 67 weeks treated with NCPAP or other NIPPV modality 5 cm H2O and FiO2 between 030 and 060 for at least 2 hours to maintain oxygen saturation by pulse oximetry SpO2 90-95
After informed consent is obtained babies are randomly assigned from sealed opaque consecutively numbered envelopes to ETT or LMA groups The ETT group is managed according to our current INSURE approach to surfactant therapy endotracheal intubation following premedication with atropine remifentanil whereas the LMA group will be pre-medicated with atropine before LMA insertion for surfactant administration
Both groups will receive Infasurf 3mLkg instilled in 2 aliquots via their respective airway followed by PPV for at least 5 minutes The artificial airway will be removed and the patient returned to NCPAPNIPPV by 15 minutes if spontaneous respirations are adequate Indications for surfactant re-dosing and mechanical ventilation will be equivalent for both groups Babies will continue or initiate assisted ventilation via ETT if any of the following occurs
Persistent apnea
Severe retractions
Inability to wean FiO2 60
Criteria for re-dosing with surfactant
1 Within 8 hours after first dose of surfactant
FiO2 20 higher than the baseline FiO2 after excluding other obvious causes of respiratory insufficiency such as pneumothorax
If early re-dosing of surfactant is needed in patients of either group it will be administered via ETT ie LMA patients will be intubated and will receive the dose of surfactant via ETT
2 Beyond 8 hours of the first dose of surfactant
FiO2 is 60 or
FiO2 is 30 associated with worsening clinical signs of RDS
If late re-dosing is needed in patients of the LMA group use of the LMA is permitted for the second dose In the ETT group all doses are given via the ETT
The main objective of this study protocol is reduce the need for endotracheal intubation and mechanical ventilation in preterm neonates with mild to moderate RDS needing rescue surfactant therapy by instilling surfactant though an LMA A second objective is to compare the efficacy of surfactant administered via LMA versus endotracheal tube ETT in decreasing the severity of RDS Additionally we will further evaluate the safety of surfactant administration via LMA
The primary hypothesis is that surfactant therapy delivered via LMA is not inferior to surfactant therapy delivered via transient intubation INSURE technique with short-acting narcotic premedication for mild to moderate RDS in preterm neonates
This randomized controlled trial will include babies with mild-to-moderate RDS less than 48 hours of age with gestational age 27 07 to 36 67 weeks treated with NCPAP or other NIPPV modality 5 cm H2O and FiO2 between 030 and 060 for at least 2 hours to maintain oxygen saturation by pulse oximetry SpO2 90-95
After informed consent is obtained babies are randomly assigned from sealed opaque consecutively numbered envelopes to ETT or LMA groups The ETT group is managed according to our current INSURE approach to surfactant therapy endotracheal intubation following premedication with atropine remifentanil whereas the LMA group will be pre-medicated with atropine before LMA insertion for surfactant administration
Both groups will receive Infasurf 3mLkg instilled in 2 aliquots via their respective airway followed by PPV for at least 5 minutes The artificial airway will be removed and the patient returned to NCPAPNIPPV by 15 minutes if spontaneous respirations are adequate Indications for surfactant re-dosing and mechanical ventilation will be equivalent for both groups Babies will continue or initiate assisted ventilation via ETT if any of the following occurs
Persistent apnea
Severe retractions
Inability to wean FiO2 60
Criteria for re-dosing with surfactant
1 Within 8 hours after first dose of surfactant
FiO2 20 higher than the baseline FiO2 after excluding other obvious causes of respiratory insufficiency such as pneumothorax
If early re-dosing of surfactant is needed in patients of either group it will be administered via ETT ie LMA patients will be intubated and will receive the dose of surfactant via ETT
2 Beyond 8 hours of the first dose of surfactant
FiO2 is 60 or
FiO2 is 30 associated with worsening clinical signs of RDS
If late re-dosing is needed in patients of the LMA group use of the LMA is permitted for the second dose In the ETT group all doses are given via the ETT
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