Respiratory Distress Syndrome (Neonatal), Surfactant Deficiency Syndrome Neonatal
Conditions
Keywords
less invasive surfactant, neonatal, video laryngoscopy
Brief 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?
Interventions
PROCEDUREVideo Laryngoscopy
Video Laryngoscopy will be used to visualize the vocal cords and place the LISA catheter
PROCEDUREDirect Laryngoscopy
Direct Laryngoscopy will be used to visualize the vocal cords and place the LISA catheter
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to 3 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of first attempt success | During procedure |
Secondary
| Measure | Time frame |
|---|---|
| Duration of desaturation below 80% SpO2 (sec), | during procedure |
| Duration of bradycardia (HR <100 bpm) | procedure duration |
| Number of desaturation/bradycardia episodes | during procedure |
| Number of surfactant installation attempts | during procedure |
| Time to completion of surfactant installation | during procedure |
| Time to insertion of thin catheter | during procedure |
| Amount of surfactant in stomach at the end of the procedure | within 5 min after procedure |
| Mean maximum fractioned inspired O2 used | during procedure |
| Lowest oxygen saturation during catheter insertion | during procedure |
| Fractionated inspired oxygen (FiO2) at 60 mins post procedure | 60 minutes post-procedure |
| Lowest heart rate during catheter insertion | during procedure |
| Cross over to alternative method | during procedure |
| Incidence of intubation at 72 hours post surfactant administration | procedure to 72 hours post-procedure |
| Incidence of pneumothorax | procedure to 72 hours post-procedure |
| Incidence of severe (grade III/IV) intraventricular hemorrhage | Birth to discharge |
| Continuous Positive Expiratory Pressure (CPAP) at 60 mins post procedure | 60 minutes post-procedure |
| Intubation during procedure | During Procedure |
| Change in provider during procedure | during procedure |
| Survival to discharge or 90 days | up to 90 days |
Countries
United States
Contacts
CONTACTPrincipal Investigator, MD
PRINCIPAL_INVESTIGATORChokshi, MD
UT Southwestern
PRINCIPAL_INVESTIGATORShalini Ramachandran, MD
UT Southwestern
Outcome results
None listed