NCT04445571 Surfactant Administration by Insure or Thin Catheter
| NCT ID | NCT04445571 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | RDS of Prematurity |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2021-05-21 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2021-05-21 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Infants born before 32 completed weeks of gestation on CPAP, with clinical and radiological signs of RDS and need for surfactant treatment. Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04445571 clinical trial?
This trial is open to participants of all sexes, up to 2 Days, studying RDS of Prematurity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04445571 currently recruiting?
Yes, NCT04445571 is actively recruiting participants. Contact the research team at kajsa.bohlin@ki.se for enrollment information.
Where is the NCT04445571 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT04445571 clinical trial?
NCT04445571 is sponsored by Karolinska Institutet. The trial plans to enroll 160 participants.