Feasibility Study of Placement and Surfactant Administration Through a Preterm Size Laryngeal Mask Airway in Very Low Birth Weight Neonates with Respiratory Distress Syndrome

Launched by KAROLINSKA INSTITUTET · Sep 18, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to help premature babies who have Respiratory Distress Syndrome (RDS), a condition that makes it hard for them to breathe. The researchers are testing a small device called a laryngeal mask airway (LMA) to see if it can be used to deliver a substance called surfactant directly into the lungs of very low birth weight babies (those weighing between 750g and 1500g at birth). The goal is to find out if this method is effective, safe, and if it causes any pain to the babies during the process.

To be eligible for this study, babies must be born in the hospital, be less than 34 weeks old, and be diagnosed with RDS, needing some help with breathing. They should be less than 48 hours old and have a specific birth weight. Parents who are interested in participating will need to give their consent. Throughout the trial, the baby's breathing, the success of the procedure, and any possible side effects will be closely monitored. This study is an important first step before larger trials can take place to prove how well this new approach works.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Parental informed consent, AND
• • Inborn neonate (=born in the hospital), AND
• • Gestational age less than 34 + 0 weeks, AND
• • Age less than 48 hours, AND
• • Birth weight from 750g to 1500g, AND
• • Clinical diagnosis of RDS requiring non-invasive respiratory support (CPAP/NIPPV) and fraction of inspired oxygen (FiO2) 0.30-0.60 to maintain oxygen saturation (SpO2) between 90% and 95%.
• Exclusion Criteria:
• • Severe respiratory insufficiency in need of emergency intubation
• • Previous surfactant administration
• • Previous mechanical ventilation
• • Known pneumothorax
• • Major malformations
• • Investigators not available