Comparing two methods for surfactant administration in preterm infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the efficacy and safety of surfactant administration using a thin catheter technique combined with analgesic premedication, compared to the established INSURE strategy. It focuses on preterm infants born before 32 weeks of gestation who are on CPAP and require surfactant treatment for respiratory distress syndrome (RDS). The study aims to assess outcomes such as oxygenation improvement, reduction in respiratory failure, and the need for mechanical ventilation within 48 hours post-procedure. Additionally, it will investigate safety aspects, including stress and pain levels during the administration process.

Why it matters

Who can join: the full rules

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.

Where it's running

• Karolinska University Hospital
  Stockholm, Sweden Recruiting

Study contacts

• Study coordinator: Kajsa Bohlin, MD
• Email: kajsa.bohlin@ki.se
• Phone: +46858580000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.