Using medication to improve surfactant administration in preterm infants
Use of Premedication for Less Invasive Surfactant Administration: A Randomized Control Trial
This study is testing if giving certain medications before a surfactant treatment can help preterm infants breathe better and reduce heart and oxygen problems during the procedure.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 0 Hours to 72 Hours |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT05065424 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of administering IV fentanyl and atropine as premedication before the Less Invasive Surfactant Administration (LISA) procedure in preterm infants with Respiratory Distress Syndrome. It is a double-blinded randomized control trial comparing the effects of this premedication against a placebo. The primary focus is to reduce the incidence of bradycardia and hypoxemia events during the LISA procedure in infants who are at least 29 weeks gestational age. The study aims to provide insights into improving procedural outcomes for vulnerable newborns.
Who should consider this trial
Good fit: Ideal candidates are preterm infants aged 0-72 hours, born at or after 29 weeks gestational age, who require the LISA procedure.
Not a fit: Patients who require intubation prior to surfactant therapy or have severe congenital anomalies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more effective surfactant administration in preterm infants, reducing complications during the procedure.
How similar studies have performed: Other studies have explored similar premedication approaches, but this specific combination in the context of LISA is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dallas, Texas
- Parkland Health and Hospital System — Dallas, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Marina Santos Oren, MD
- Email: venkat.kakkilaya@utsouthwestern.edu
- Phone: 2146483903
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.