Surfactant Administration by Insure or Thin Catheter

Launched by KAROLINSKA INSTITUTET · Jun 22, 2020

Keywords

ClinConnect Summary

This clinical trial is studying two different methods of administering a treatment called surfactant for premature infants who have a condition known as Respiratory Distress Syndrome (RDS). Surfactant helps to improve breathing by keeping the tiny air sacs in the lungs open. The trial is comparing a newer method using a thin catheter along with pain relief medication to the established method called INSURE, which is commonly used. The goal is to find out which method is safer and more effective for these vulnerable babies.

To be eligible for this trial, infants must be born before 32 weeks of pregnancy, need assistance with breathing (using a device called CPAP), and show signs of RDS that require surfactant treatment. However, babies who need surfactant immediately after birth or have specific health problems affecting their breathing will not be included in the study. If participants join, they can expect to receive one of the two methods being tested while being closely monitored by healthcare professionals to ensure their safety and comfort. This research aims to improve how we treat premature infants with breathing difficulties, ultimately helping them breathe better and thrive.

Gender

ALL

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.