Premedication for Less Invasive Surfactant Administration

Launched by UNIVERSITY OF OULU · Nov 7, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a method for delivering surfactant, a substance that helps keep the lungs open, to preterm infants who have breathing difficulties. The goal is to find the best way to prepare these babies for the procedure, using either ketamine or fentanyl as medication beforehand. These medications are meant to help reduce pain without making it hard for the baby to breathe. Researchers want to see which medication leads to fewer problems during and after the procedure.

To be eligible for this trial, infants must be born at least 26 weeks gestation and need help with breathing, but not through invasive methods like intubation (a tube inserted into the windpipe). If a baby needs more than one dose of surfactant, they can be included again in the study. Parents can expect that their baby will receive either ketamine or fentanyl before the surfactant is given, and the doctors will closely monitor their baby's health and any side effects. This research is important because it could help improve the care of premature infants with breathing issues while minimizing risks.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Gestational age at birth ≥26 weeks
• • Respiratory insufficiency managed with non-invasive respiratory support (nasal continuous positive airway pressure or high-flow)
• • Requirement for oxygen to maintain oxygen saturation in the target range and need for surfactant treatment (according to clinician's assessment)
• • If further doses of surfactant are needed, patient can be re-randomized
• Exclusion Criteria:
• • Severe RDS with high oxygen requirements, severe respiratory acidosis and/or widespread atelectasis radiologically, such that ongoing ventilator support will be necessary after surfactant therapy (intubation in preferable to LISA if FiO2 \>40% at GA \<28 weeks and \>60% at GA ≥28 weeks)
• • Maxillo-facial, tracheal or known pulmonary malformations
• • Any known chromosomal abnormality or severe malformation
• • An alternative cause for respiratory distress (e.g. congenital pneumonia or pulmonary hypoplasia)