Surfactant Administration by Insure or Thin Catheter
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
| Condition(s) | RDS of Prematurity, Surfactant Deficiency Syndrome Neonatal, Analgesia |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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. |
| Ages | 2 Days |
| Sex | All |
| Lead sponsor | Karolinska Institutet |
| Locations | Stockholm, Sweden |
| Start date | 2021-05-21 |
| NCT ID | NCT04445571 |
| Official listing | https://clinicaltrials.gov/study/NCT04445571 |