Ignite Creation Date:
2024-05-05 @ 10:10 PM
Last Modification Date:
2024-10-26 @ 10:14 AM
Study NCT ID:
NCT01042600
Status:
COMPLETED
Last Update Posted:
2019-07-26
First Post:
2010-01-04
Brief Title:
Randomized Controlled Trial of Surfactant Delivery Via Laryngeal Mask Airway LMA Versus Endotracheal Intubation
Sponsor:
Albany Medical College
Organization:
Albany Medical College
Study Overview
Official Title:
Rescue Surfactant for Respiratory Distress Syndrome RDS in Newborns Comparing Efficacy of Delivery Via Laryngeal Mask Airway to Delivery by Endotracheal Intubation
Status:
COMPLETED
Status Verified Date:
2019-07
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:
In this study newborn babies with respiratory distress syndrome RDS receiving oxygen via nasal CPAP and needing surfactant treatment will be randomized to standard delivery of surfactant via and endotracheal tube airwayinserted after pre-medication for pain or to surfactant delivery via laryngeal mask airway LMA The intent is to remove the airways and return babies to nasal CPAP 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 CPAP needs mechanical ventilation or b late if the baby requires 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 with standard surfactant treatment following sedation and endotracheal intubation
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 with standard surfactant treatment following sedation and endotracheal intubation
Detailed Description:
Respiratory Distress Syndrome RDS due to deficiency of lung 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 NCPAP The current standard method of surfactant delivery requires tracheal intubation and at least brief positive-pressure ventilation Tracheal intubation causes pain and leads to vagal-mediated physiologic instability in neonates therefore premedication with morphine and atropine is routinely practiced in our setting However premedication with morphine often increases respiratory depression requiring sustained mechanical ventilation 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 and preliminary data suggest that it can be used for surfactant administration
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 evaluate the safety of surfactant administration via LMA
The primary hypothesis is that surfactant treatment via the LMA approach will decrease the proportion of babies with RDS who require mechanical ventilation or subsequent intubation when compared with standard surfactant as administered to the ETT group
This randomized controlled trial will include babies with mild-to-moderate RDS between 4 to 48 hours of age with gestational age 29 07 to 36 67 weeks treated with NCPAP 5 cm H2O and FiO2 between 030 and 060 for at least 2 hours to maintain SpO2 88-95 and informed consent Exclusion criteria are weight 1000 g airway anomalies pulmonary air leaks and craniofacial and cardiothoracic malformations
After informed consent is obtained babies are randomly assigned from sealed opaque consecutively numbered envelopes to the ETT or LMA The ETT group is managed according to our current practice of surfactant therapy endotracheal intubation following premedication with atropine morphine 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 NCPAP 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 early re-dosing
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 the dose 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 late re-dosing
FiO2 is 60 or
FiO2is 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
Primary Outcome Measures
Rate of failure of early surfactant rescue therapy in the 2 groups using the following criteria to differentiate early from late failure
Criteria for early failure within 1 hour
1 The need of mechanical ventilation within 1 hour of surfactant therapy
2 Use of Narcan to avoid mechanical ventilation after surfactant therapy
Criteria for late failure beyond 1 hour
1 Sustained FiO2 060 to maintain target SpO2
2 Second dose of surfactant within 8 hours after the first dose
3 More than 2 doses of surfactant
Babies will have FiO2 adjusted to maintain SpO2 88-95 per current practice Other aspects of weaning ventilatory support will be managed by clinicians preference
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 evaluate the safety of surfactant administration via LMA
The primary hypothesis is that surfactant treatment via the LMA approach will decrease the proportion of babies with RDS who require mechanical ventilation or subsequent intubation when compared with standard surfactant as administered to the ETT group
This randomized controlled trial will include babies with mild-to-moderate RDS between 4 to 48 hours of age with gestational age 29 07 to 36 67 weeks treated with NCPAP 5 cm H2O and FiO2 between 030 and 060 for at least 2 hours to maintain SpO2 88-95 and informed consent Exclusion criteria are weight 1000 g airway anomalies pulmonary air leaks and craniofacial and cardiothoracic malformations
After informed consent is obtained babies are randomly assigned from sealed opaque consecutively numbered envelopes to the ETT or LMA The ETT group is managed according to our current practice of surfactant therapy endotracheal intubation following premedication with atropine morphine 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 NCPAP 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 early re-dosing
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 the dose 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 late re-dosing
FiO2 is 60 or
FiO2is 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
Primary Outcome Measures
Rate of failure of early surfactant rescue therapy in the 2 groups using the following criteria to differentiate early from late failure
Criteria for early failure within 1 hour
1 The need of mechanical ventilation within 1 hour of surfactant therapy
2 Use of Narcan to avoid mechanical ventilation after surfactant therapy
Criteria for late failure beyond 1 hour
1 Sustained FiO2 060 to maintain target SpO2
2 Second dose of surfactant within 8 hours after the first dose
3 More than 2 doses of surfactant
Babies will have FiO2 adjusted to maintain SpO2 88-95 per current practice Other aspects of weaning ventilatory support will be managed by clinicians preference
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