100 Participants NeededMy employer runs this trial

Laryngoscopy Methods for Neonatal Respiratory Distress Syndrome

(VID LISA Trial)

PI
Overseen ByPrincipal Investigator, MD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Texas Southwestern Medical Center
Must be taking: Surfactant
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to help preterm babies with breathing problems by administering a medicine called surfactant. Researchers aim to determine whether using a video laryngoscope (a camera) or direct laryngoscopy (without a camera) is more effective for successful first-attempt administration. They also assess any additional benefits each method might offer. This trial targets preterm babies born at or before 28 weeks who have received initial breathing support and require surfactant within the first 36 hours after birth. As an unphased trial, it provides a unique opportunity to contribute to important research that could enhance care for preterm infants.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that these laryngoscopy methods are safe for neonatal respiratory distress syndrome?

Studies have shown that using video laryngoscopy during a less invasive method of administering surfactant to newborns appears promising. Research indicates that video laryngoscopy increases the likelihood of success on the first attempt and may reduce the risk of complications compared to traditional methods. It has been associated with shorter durations of breathing support and oxygen use.

In contrast, direct laryngoscopy has led to issues such as low heart rate and oxygen levels in some babies during the procedure. For example, one study reported that 7% of babies experienced a drop in heart rate, and 77% had lower oxygen levels. These findings suggest that while both methods are used, video laryngoscopy might offer a safer option for newborns requiring surfactant treatment.12345

Why are researchers excited about this trial?

Researchers are excited about exploring different laryngoscopy methods for treating Neonatal Respiratory Distress Syndrome because these techniques could improve the way surfactant is administered to babies. Video laryngoscopy offers a unique advantage by using a camera to provide a clearer view of the vocal cords, which could lead to more accurate placement of the LISA catheter. On the other hand, direct laryngoscopy, while more traditional, doesn't rely on a camera and could be quicker in emergency situations. By comparing these two methods, researchers hope to find out which is more effective or safer, potentially leading to better outcomes for newborns with this serious condition.

What evidence suggests that these laryngoscopy methods are effective for neonatal respiratory distress syndrome?

This trial will compare two methods for placing a breathing tube in newborns with respiratory distress syndrome: video laryngoscopy and direct laryngoscopy. Research has shown that video laryngoscopy helps doctors place a breathing tube in a newborn's windpipe more successfully on the first try. Specifically, one study found that video laryngoscopy improved first attempt success rates by 46% compared to the traditional method, direct laryngoscopy. This method often makes it easier and more effective for doctors to see where to place the tube. In contrast, direct laryngoscopy has been less successful, particularly for doctors in training. Overall, video laryngoscopy may provide a safer and more effective way to assist preterm babies with breathing problems.12356

Who Is on the Research Team?

CM

Chokshi, MD

Principal Investigator

UT Southwestern

SR

Shalini Ramachandran, MD

Principal Investigator

UT Southwestern

Are You a Good Fit for This Trial?

This trial is for premature babies born at or before 28 weeks who are stable after birth and need surfactant medicine within their first 36 hours of life to help with breathing problems.

Inclusion Criteria

My baby was born at or before 28 weeks and needed CPAP and surfactant soon after birth.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo less invasive surfactant administration using either video or direct laryngoscopy

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surfactant administration

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Direct Laryngoscopy
  • Video Laryngoscopy

Trial Overview

The study compares two ways of helping doctors see the airway when giving surfactant: using a video camera (video laryngoscopy) versus looking directly (direct laryngoscopy) during a less invasive procedure. Babies are randomly assigned to one method.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Video LaryngoscopyActive Control1 Intervention
Group II: Direct LaryngoscopyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+

Citations

Procedural success and safety of a standardized less invasive ...

This study provides detailed data on the procedural quality of LISA when opioid analgesia and video laryngoscopy are used. This data may inform future trials ...

Surfactant Administration in Preterm babies (28-36 weeks) ...

12% (n=9, LISA group) & 14.6% (n=11 InSurE group) had adverse events during the procedure. Also, we observed insignificant statistical difference in the rates ...

Comparative efficacy and safety of pulmonary surfactant ...

To compare five pulmonary surfactant (PS) administration strategies for neonates with respiratory distress syndrome (RDS), including intubation-surfactant- ...

Effectiveness and safety profile of introducing less invasive ...

This study aimed to evaluate the effects of introducing LISA in the management of RDS on health outcomes and the safety profile.

Outcomes, safety and health economics of introduction ...

Systematic reviews confirmed that LISA significantly improved outcomes for infants with RDS when compared to InSurE [7]. Currently, the European ...

Neonatal Respiratory Distress Syndrome - StatPearls - NCBI

The disorder results in alveolar collapse, reduced lung compliance, hypoxemia, and progressive respiratory failure shortly after birth. This ...