Comparing two methods for surfactant administration in preterm infants
Surfactant Administration by Insure or Thin Catheter
NA · Karolinska Institutet · NCT04445571
This study is testing a new way to give surfactant to preterm infants with breathing problems to see if it helps them breathe better and feel less pain compared to the usual method.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | N/A to 2 Days |
| Sex | All |
| Sponsor | Karolinska Institutet (other) |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT04445571 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are infants born before 32 completed weeks of gestation who are on CPAP and show clinical signs of RDS requiring surfactant treatment.
Not a fit: Patients who may not benefit from this study include those requiring surfactant as part of delivery room resuscitation or those with congenital abnormalities affecting breathing.
Why it matters
Potential benefit: If successful, this study could enhance lung protective treatment strategies for preterm infants, potentially improving their oxygenation and reducing the need for invasive ventilation.
How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Stockholm
- Karolinska University Hospital — Stockholm, Sweden (RECRUITING)
Study contacts
- Study coordinator: Kajsa Bohlin, MD
- Email: kajsa.bohlin@ki.se
- Phone: +46858580000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: RDS of Prematurity, Surfactant Deficiency Syndrome Neonatal, Analgesia, LISA, INSURE, CPAP