Status:
RECRUITING
Surfactant Administration by Insure or Thin Catheter
Lead Sponsor:
Karolinska Institutet
Conditions:
RDS of Prematurity
Surfactant Deficiency Syndrome Neonatal
Eligibility:
All Genders
Up to 2 years
Phase:
NA
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...
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, ...
Eligibility Criteria
Inclusion
- Infants born before 32 completed weeks of gestation on CPAP, with clinical and radiological signs of RDS and need for surfactant treatment.
Exclusion
- Infants requiring surfactant as part of delivery room resuscitation are not eligible.
- Infants will be excluded from the final analysis if they have a congenital abnormality or condition that might have an adverse effect on breathing or ventilation, including: congenital diaphragmatic hernia; tracheo-oesophageal fistula or cyanotic heart disease.
Key Trial Info
Start Date :
May 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04445571
Start Date
May 21 2021
End Date
December 31 2026
Last Update
July 1 2025
Active Locations (1)
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1
Karolinska University Hospital
Stockholm, Sweden, 14186