Premedication for Less Invasive Surfactant Administration Study (PRELISA)

Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · Sep 22, 2021

Keywords

ClinConnect Summary

The PRELISA study is researching a new way to help premature infants with a condition called Respiratory Distress Syndrome, which makes it hard for them to breathe. The goal of this trial is to see if giving these infants two medications, IV fentanyl and atropine, before a procedure called Less Invasive Surfactant Administration (LISA) can make the procedure safer and more effective. Researchers want to find out if this premedication can reduce problems like low heart rates and low oxygen levels during the procedure, compared to giving a placebo (a substance with no active medication).

To participate in this study, infants must be at least 29 weeks old and require respiratory support with CPAP (a type of breathing assistance). However, infants who need to be intubated (have a breathing tube placed) beforehand or have certain serious health conditions are not eligible. If your infant qualifies and joins the study, they will receive either the medications or a placebo before the procedure, and their health will be closely monitored to see how well they do. This research could help improve care for premature babies in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Infants ≥29 weeks gestational age between 0-72 hours of life on CPAP for respiratory support who qualify for the LISA procedure as determined by the primary team using Parkland OPTISURF guidelines
• Exclusion Criteria:
• • Infants requiring intubation prior to surfactant therapy
• • Infants with known severe congenital anomalies (including complex congenital heart disease, airway, and central nervous system anomalies)
• • Infants born to mothers with known opioid addiction or in a methadone treatment program