Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06606444
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Feasibility Study of Placement and Surfactant Administration Through a Preterm Size Laryngeal Mask Airway in Very Low Birth Weight Neonates with Respiratory Distress Syndrome
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single-arm Prospective Feasibility Study of Placement and Surfactant Administration Through a Preterm Size Laryngeal Mask Airway in Very Low Birth Weight Neonates with Respiratory Distress Syndrome At a Level III Neonatal Intensive Care Unit in Hanoi Vietnam
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Surfactant administration via a supraglottic airway device or laryngeal mask airway SALSA is a minimally invasive method of instilling surfactant in the trachea during spontaneous breathing and after applying nasal continuous positive airway pressure nCPAP However the procedure has been limited from use in very low birth weight neonates due to lack of preterm size LMAs which are now emerging on the market
The goal of this study is to see if investigators can successfully use a new smaller laryngeal mask airway LMA to place and give surfactant to premature babies with respiratory distress syndrome RDS who weigh between 750g and 1500g at birth
The main objectives of the study are to
Check the placement of the new smaller LMA This includes evaluating the airway how long it takes to place the LMA how many attempts are needed and the babys stability during the process
Evaluate the administration of surfactant using the new LMA Investigators will look at how the baby responds clinically any changes in oxygen needs how many doses of surfactant are required the level of respiratory support needed and whether intubation or mechanical ventilation is necessary
Ensure the safety of using the new LMA and administering surfactant Investigators will monitor the babys stability during the procedure and watch for any adverse events
Assess pain during the procedure Investigators will evaluate pain levels using a pain scale based on video reviews
Above objectives of feasibility are to be assessed before proceeding to a large randomize clinical trial assessing effectiveness and safety
The goal of this study is to see if investigators can successfully use a new smaller laryngeal mask airway LMA to place and give surfactant to premature babies with respiratory distress syndrome RDS who weigh between 750g and 1500g at birth
The main objectives of the study are to
Check the placement of the new smaller LMA This includes evaluating the airway how long it takes to place the LMA how many attempts are needed and the babys stability during the process
Evaluate the administration of surfactant using the new LMA Investigators will look at how the baby responds clinically any changes in oxygen needs how many doses of surfactant are required the level of respiratory support needed and whether intubation or mechanical ventilation is necessary
Ensure the safety of using the new LMA and administering surfactant Investigators will monitor the babys stability during the procedure and watch for any adverse events
Assess pain during the procedure Investigators will evaluate pain levels using a pain scale based on video reviews
Above objectives of feasibility are to be assessed before proceeding to a large randomize clinical trial assessing effectiveness and safety
Detailed Description:
Methodology Feasibility will be measure by a combination of real-life observations of the procedure and video-review with synced physiological data oxygen saturation and heart rate
Study Site The Phu San Hanoi Hospital the largest obstetric hospital in northern Vietnam receives about 40000 births annually and has a level-III neonatal intensive care unit with capacity of approximately 40 neonates Approximately 10-15 neonates weighing less than 1500g per month are admitted who receives standard surfactant treatment with IN-tubation-SURfactant-Extubation INSURE
Study Site The Phu San Hanoi Hospital the largest obstetric hospital in northern Vietnam receives about 40000 births annually and has a level-III neonatal intensive care unit with capacity of approximately 40 neonates Approximately 10-15 neonates weighing less than 1500g per month are admitted who receives standard surfactant treatment with IN-tubation-SURfactant-Extubation INSURE
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