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NCT07426016
Video vs. Direct Laryngoscopy for Less Invasive Surfactant Administration
Conditions: Respiratory Distress Syndrome (Neonatal), Surfactant Deficiency Syndrome Neonatal
Sex: All
Ages: 0 Hours – 3 Days
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: University of Texas Southwestern Medical Center
Location: Parkland Hospital Dallas Texas
Summary
Many preterm babies born between 22-28+6 weeks' estimated gestational age (EGA) need surfactant, a medicine that helps the lungs. The goal of the study is to compare the use of video-based visualization to direct visualization during a procedure called less invasive surfactant administration (LISA). The main questions the study aims to answer are: 1) does one method of visualization have a increased rate of giving the medicine successfully on the first attempt? 2) what benefits are there of each method?
Eligibility Criteria
Inclusion Criteria:
* Infants born ≤28 weeks GA successfully resuscitated in the delivery room (DR) and maintained on CPAP • Need for surfactant in the first 36 hours of life based on clinical assessment and/or meeting threshold per unit protocol
Exclusion Criteria:
* Infants born ≥29 weeks GA or
* Infants with known congenital anomalies or
* Infants who are determined by the primary care team to receive comfort care only or
* Infants who are intubated at any time prior to surfactant administration
Source: ClinicalTrials.gov (NCT07426016). StuddyBuddy aggregates publicly available trial information.