Ignite Creation Date:
2024-05-06 @ 2:51 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04445571
Status:
RECRUITING
Last Update Posted:
2023-10-12
First Post:
2020-06-22
Brief Title:
Surfactant Administration by Insure or Thin Catheter
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
Surfactant Administration by Insure or Thin Catheter
Status:
RECRUITING
Status Verified Date:
2023-10
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:
SAINT
Brief Summary:
This trial evaluates the efficacy and safety of surfactant administration with thin catheter technique together with analgesic premedication in comparison with the established INSURE-strategy It will provide valuable knowledge to improve clinical methodology and enhance lung protective treatment strategies for preterm infants
Detailed Description:
To compare two approaches for surfactant administration during CPAP in preterm infants the INSURE and the LISA technique using premedication intubation protocols and investigate aspects of safety stress and pain timely administration of the drug response in oxygenation and pulmonary outcome
Our study asks whether P among infants born 32 weeks gestation with RDS I does surfactant administration with LISA and analgesia premedication C versus surfactant administration according to the INSURE protocol O improve oxygenation and reduce the rate of respiratory failure and need for intubation and mechanical ventilation T within 48 hours of the procedure
Primary outcomes
1 Positive effect Oxygenation measured as arterial to alveolar ratio aA ratio at 24 hours post-procedure
2 Negative effect Need for mechanical ventilation MV within 48 hours post-procedure
Safety outcomes
1 Time from meeting the FiO2 or aA ratio criteria for surfactant treatment until surfactant administration
2 Number of tries before successful intubationplacement of catheter
3 Positive pressure ventilation during the procedure - yesnoduration minutes
4 Stress and pain changes in heart rate blood pressure and BIIP-scale
Our study asks whether P among infants born 32 weeks gestation with RDS I does surfactant administration with LISA and analgesia premedication C versus surfactant administration according to the INSURE protocol O improve oxygenation and reduce the rate of respiratory failure and need for intubation and mechanical ventilation T within 48 hours of the procedure
Primary outcomes
1 Positive effect Oxygenation measured as arterial to alveolar ratio aA ratio at 24 hours post-procedure
2 Negative effect Need for mechanical ventilation MV within 48 hours post-procedure
Safety outcomes
1 Time from meeting the FiO2 or aA ratio criteria for surfactant treatment until surfactant administration
2 Number of tries before successful intubationplacement of catheter
3 Positive pressure ventilation during the procedure - yesnoduration minutes
4 Stress and pain changes in heart rate blood pressure and BIIP-scale
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