NeoVest for Neonatal Respiratory Distress Syndrome

(Neovest Trial)

Overseen By Douglas Campbell, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Unity Health Toronto

Must not be taking: Inotropic medications

Disqualifiers: Apnoea, Bradycardia, Genetic conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 22 minutes

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the NeoVest, designed to assist babies with breathing problems. The NeoVest is a gentle, wearable vest that aids infants' breathing by softly pulling on the stomach. Researchers aim to determine if this device can safely support stable babies who still require breathing assistance. Babies in the neonatal intensive care unit (NICU) at St. Michael's Hospital, weighing more than 1.5 kg and experiencing mild breathing issues, may qualify for this trial. As an unphased trial, participation offers an opportunity to contribute to innovative research that could enhance infant care.

Do I have to stop my baby's current medications for the trial?

The trial protocol does not specify whether infants need to stop their current medications. However, infants requiring inotropic medications (drugs that affect heart contraction) are excluded, which might imply some restrictions.

What prior data suggests that the NeoVest device is safe for infants?

Research shows that specific safety information for NeoVest, a new wearable device for infants with breathing problems, is not yet available. As the research process is still in its early stages, the device is being studied to gather evidence on its safety and effectiveness.

NeoVest aids infant breathing by gently applying light suction to the abdomen, designed to be gentle on sensitive skin.

Although direct safety data is not yet available, the ongoing study indicates that the device has shown enough potential for further testing. Generally, devices and treatments must pass several safety checks before being tested on babies, suggesting that the risks are considered manageable at this stage. However, as with any new treatment, it is important to consider both the potential risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

NeoVest is unique because it uses negative pressure ventilation, a different approach compared to the usual positive pressure ventilation methods like CPAP and mechanical ventilation commonly used for Neonatal Respiratory Distress Syndrome. This method mimics the natural breathing process more closely, potentially leading to less lung injury and better outcomes for newborns. Researchers are excited about NeoVest because it could offer a gentler and more physiologically aligned way of supporting fragile newborns' breathing.

What evidence suggests that the NeoVest device is effective for neonatal respiratory distress syndrome?

Research shows that the NeoVest could help babies with breathing problems by gently assisting chest movement, making breathing easier. The materials are soft on the baby's skin, and the design is based on measurements from other babies in the hospital. Although specific data on NeoVest's effectiveness for neonatal respiratory distress syndrome (NRDS) is limited, similar gentle breathing support methods have shown promise in other studies. For instance, these methods have improved breathing and reduced complications in premature babies. Participants in this trial will receive the NeoVest as an experimental treatment to evaluate its effectiveness for NRDS. ^{1 6 7 8 9}

Who Is on the Research Team?

Douglas Campbell, MD

Principal Investigator

Unity Health Toronto

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am within the first two weeks of my life.

This criterion refers to 20 babies who are currently in the Neonatal Intensive Care Unit at St. Michael's Hospital.

You weighed more than 1.5 kilograms at birth.

Exclusion Criteria

My infant has a visible belly or chest abnormality.

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

My infant has an umbilical catheter.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive negative pressure ventilation using the NeoVest device, synchronized to the infant's respiratory demand

22 minutes

Single session

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NeoVest

Trial Overview 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.

How Is the Trial Designed?

Group I: NeoVest Experimental Treatment 1 Intervention

Negative pressure ventilation using NeoVest

Who Is Running the Clinical Trial?

Unity Health Toronto

Lead Sponsor

Trials

572

Recruited

470,000+

Published Research Related to This Trial

In a study of 100 neonates with neonatal respiratory distress syndrome (NRDS), nasal intermittent positive pressure ventilation (NIPPV) was found to be more effective than nasal continuous positive airway pressure (NCPAP) in reducing CO2 retention and improving oxygenation within the first 6 hours of treatment.

NIPPV also resulted in significantly lower rates of second endotracheal intubation and reduced the need for additional pulmonary surfactant, indicating its potential to improve overall respiratory support outcomes in neonates with NRDS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical application of nasal intermittent positive pressure ventilation in initial treatment of neonatal respiratory distress syndrome]. Fu, CH., Xia, SW.[2014]

A new NICU-focused trigger tool was developed and tested, revealing a high incidence of adverse events in hospitalized children, with 554 unique adverse events identified across 749 charts, averaging 0.74 events per patient.

The study found that 56% of these adverse events were preventable, highlighting the need for improved safety measures, as only 8% were reported through traditional hospital reporting systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in the neonatal intensive care unit: development, testing, and findings of an NICU-focused trigger tool to identify harm in North American NICUs. Sharek, PJ., Horbar, JD., Mason, W., et al.[2021]

Citations

1. withpower.com withpower.com/trial/phase-respiratory-distress-syndrome-4-2019-f4fd3

NeoVest for Neonatal Respiratory Distress Syndrome This trial tests the NeoVest, a wearable vest that helps infants with breathing problems by gently pulling on their abdomen.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12370393/

A Meta-Analysis Comparing Minimally Invasive Surfactant ... Conclusion: MIST proved to be a safer and more effective alternative to INSURE in preterm infants with NRDS, reducing several complications and mechanical ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1355184125000031

Neonatal respiratory outcomes following nebulised ... To determine if nebulised delivery of surfactant is a safe and effective method of administration in improving respiratory outcomes in preterm infants.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11048199/

The Outcomes of Preterm Infants with Neonatal Respiratory ... In the NIPPV group, there was a statistically significant increase in pH from 7.23 to 7.36 and a significant decrease in PvCO2 from 56.1 mmHg to ...

5. journals.lww.com journals.lww.com/md-journal/fulltext/2020/11250/nebulized_versus_invasively_delivered_surfactant.19.aspx

Nebulized versus invasively delivered surfactant therapy... Nebulized inhalation of pulmonary surfactant Curosurf might be effective in treatment of NRDS by improving lung function. Guo,2007, China ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK560779/

Neonatal Respiratory Distress Syndrome - StatPearls - NCBI Neonatal respiratory distress syndrome, or RDS, is a common cause of respiratory distress in a newborn, presenting within hours after birth.

7. uspharmacist.com uspharmacist.com/article/a-review-of-neonatal-respiratory-distress-syndrome

A Review of Neonatal Respiratory Distress Syndrome Prematurity is a major risk factor for RDS, as insufficient surfactant production is closely associated with underdeveloped lungs.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33235071/

Nebulized versus invasively delivered surfactant therapy ... We aimed to conduct this meta-analysis to evaluate the effects and safety of nebulized versus invasively delivered PS in the treatment of NRDS.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT02294630

NCT02294630 | Aerosolized Surfactant in Neonatal RDS Respiratory distress syndrome (RDS), caused by surfactant deficiency, is the leading cause of mortality and morbidity in preterm infants.