What side effects are associated with this type of intervention?

Common treatments for Neonatal Respiratory Distress Syndrome (NRDS) include Continuous Positive Airway Pressure (CPAP), mechanical ventilation, and surfactant therapy. CPAP can cause nasal trauma, abdominal distension, and air leaks such as pneumothorax. Mechanical ventilation may lead to lung injury, infections, and chronic lung disease. Surfactant therapy is generally well-tolerated but can occasionally cause transient bradycardia, oxygen desaturation, and pulmonary hemorrhage. Negative Pressure Non-Invasive Ventilation (NIV), like the NeoVest, aims to reduce lung injury compared to positive pressure methods, but potential side effects may include skin irritation and discomfort due to the wearable device.

What prior FDA approvals exist?

FDA-approved treatments for Neonatal Respiratory Distress Syndrome (RDS) primarily include surfactant replacement therapy and positive pressure ventilation methods such as Continuous Positive Airway Pressure (CPAP) and mechanical ventilation. Surfactant therapy involves administering surfactant extracts to reduce surface tension in the lungs, improving oxygenation. Positive pressure ventilation supports breathing by maintaining airway pressure. While the NeoVest, which uses negative pressure non-invasive ventilation (NIV), is a novel approach, it is not yet FDA-approved, and current treatments do not typically involve negative pressure methods.

What other types of research exist?

Promising alternatives to NeoVest for treating Neonatal Respiratory Distress Syndrome include: 1) Nebulized surfactant therapy using devices like the eFlow-Neos nebulizer, which has shown effectiveness and safety in non-invasive surfactant administration. 2) High-flow nasal cannula (HFNC) therapy, which provides heated and humidified oxygen at high flow rates and has been increasingly used for neonatal respiratory support. 3) Non-invasive neurally adjusted ventilatory assist (NIV-NAVA), which synchronizes ventilation with the infant's own respiratory efforts, improving comfort and efficacy. These alternatives offer non-invasive options that can potentially improve outcomes for neonates with RDS.

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Negative Pressure Ventilation

NeoVest for Neonatal Respiratory Distress Syndrome (Neovest Trial)

N/A

Recruiting

Led By Douglas Campbell, MD

Research Sponsored by Unity Health Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Within the first two weeks of life

Clinically stable, with symptoms of respiratory distress (due to transient tachypnea of the newborn, respiratory distress syndrome, etc.)

Must not have

Infants with abdominal wall defects and other visible abnormalities of the abdomen or chest

Infants with clinically significant apnoea or bradycardia (> 2 A&B in last hour, or apnea >20 sec, or bradycardia requiring significant stimulation)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 22 minutes

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the NeoVest, a wearable vest that helps infants with breathing problems by gently pulling on their abdomen. It is designed for premature and full-term infants who need breathing support. The vest assists breathing and synchronizes with the baby's natural breaths.

Who is the study for?

This trial is for babies over 1.5kg who are stable but have breathing difficulties like transient tachypnea or respiratory distress syndrome, and have been on nasal CPAP for at least 6 hours within their first two weeks of life. Babies with high oxygen needs, upper airway distress, significant apnoea/bradycardia, unstable blood pressure, recent extubation, certain catheters in place or allergies to silicone can't participate.

What is being tested?

The study tests the NeoVest device—a wearable vest that applies gentle negative pressure on a baby's abdomen to help with breathing. It aims to show this method is feasible and synchronized with the infant's own breaths. The data will support applications for larger studies.

What are the potential side effects?

Potential side effects may include skin irritation due to the vest material or discomfort from the negative pressure application. However, specific side effects will be monitored as part of the study's aim to establish feasibility.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am within the first two weeks of my life.

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My newborn is stable but has breathing difficulties.

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I have been using a CPAP machine at a low pressure setting for at least 6 hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My infant has a visible belly or chest abnormality.

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My infant has had serious breathing pauses or slow heart rate recently.

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My infant has an umbilical catheter.

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My infant needs extra oxygen (more than 35% oxygen in the air they breathe).

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My infant was recently taken off a ventilator.

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My infant has a genetic condition or unusual facial features.

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My infant shows signs of breathing difficulty.

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My infant has unstable blood pressure or needs special medication for heart and blood flow.

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My infant cannot have an NG tube placed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 22 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~22 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 22 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility of negative pressure ventilation with NeoVest

Secondary study objectives

Blood Pressure

Diaphragm Electrical Activity

Heart Rate

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: NeoVestExperimental Treatment1 Intervention

Negative pressure ventilation using NeoVest

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Neonatal Respiratory Distress Syndrome (NRDS) include surfactant therapy, mechanical ventilation, and non-invasive ventilation methods such as the NeoVest. Surfactant therapy involves administering surfactant directly into the lungs to reduce surface tension, thereby preventing alveolar collapse and improving oxygenation. Mechanical ventilation provides controlled breathing support to maintain adequate oxygen levels and remove carbon dioxide. Non-invasive ventilation methods like the NeoVest use gentle, synchronized negative pressure to assist the infant's natural breathing efforts, reducing the need for intubation and minimizing lung injury. These treatments are crucial for NRDS patients as they enhance lung function, improve gas exchange, and reduce the risk of long-term respiratory complications.

Efficacy study of pulmonary surfactant combined with assisted ventilation for acute respiratory distress syndrome management of term neonates.