Health TrialsbyHealthPanel

Video vs. Direct Laryngoscopy for Less Invasive Surfactant Administration

ConditionsRespiratory Distress Syndrome (Neonatal)Surfactant Deficiency Syndrome Neonatal
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-3
SponsorUniversity of Texas Southwestern Medical Center

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Video Laryngoscopy

    Procedure/Surgery

    Video Laryngoscopy will be used to visualize the vocal cords and place the LISA catheter

  • Direct Laryngoscopy

    Procedure/Surgery

    Direct Laryngoscopy will be used to visualize the vocal cords and place the LISA catheter

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Video LaryngoscopyActive comparator 1 intervention
Group B: Direct LaryngoscopyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rate of first attempt success

Time frame
During procedure

Secondary outcomes

1

Duration of desaturation below 80% SpO2 (sec),

Time frame
during procedure
2

Duration of bradycardia (HR <100 bpm)

Time frame
procedure duration
3

Number of desaturation/bradycardia episodes

Time frame
during procedure
4

Number of surfactant installation attempts

Time frame
during procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Texas Southwestern Medical Center

Lead sponsor

Source ClinicalTrials.gov
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